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Today, we're advancing programs in Endocrinology Rare Disease and Oncology.\r\nHere at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.\r\nGuided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.\r\nOur culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.\r\nThe Medical Director is involved in the design, monitoring, data analysis, and interpretation of the Company’s late-phase clinical trials in endocrinology. As such, the Medical Director is an important and visible member of the clinical development team. The Medical Director position is based in the United States (preferably in Palo Alto, California) and will report to the Vice President, Clinical Science.\r\n\r\nKey Responsibilities\r\n Contribute to formulation and implementation of the Clinical Development Plan\r\n Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program\r\n For clinical trials: design, provide overall oversight, and support site and subject retention\r\n Serve as a Medical Monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy data\r\n Provide leadership to teams of medical monitors\r\n Provide leadership to study teams\r\n Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members\r\n Ensure study integrity, and track accumulating safety and efficacy data\r\n Analyze, evaluate, interpret, and report clinical data\r\n Anticipate and solve complex drug development problems\r\n Contribute to regulatory strategy\r\n Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions\r\n Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance\r\n Collaborate with—and serve as a clinical research resource for—cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development\r\n Contribute to (and may be asked to represent the clinical development department in) corporate strategic and organizational initiatives\r\n Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company\r\n Assist in portfolio management and commercial activities as needed\r\n Complete assigned tasks thoroughly, accurately, and on time\r\n Adhere to rigorous ethical standards\r\n Requirements\r\nKnowledge, Skills and Experience\r\n M.D. degree\r\n Completion of ACGME-accredited residency and fellowship (strongly preferred)\r\n Physician licensure in at least one state (strongly preferred)\r\n Board-certified (strongly preferred), with specialty in endocrinology highly desired\r\n At least 5 years of industry experience (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis). Those with less experience may be considered for an Associate Medical Director position.\r\n At least 3 years of experience with clinical trial design and execution\r\n Strong track record of scientific and clinical inquiry\r\n Possess excellent communication skills (written and oral)\r\n Learn quickly, follow complex directions under pressure\r\n Multi-task while remaining organized and attentive to detail\r\n Lead both directly and by example\r\n Work hard, be a trustworthy and collaborative team player\r\n Take initiative and solve complex problems\r\n Demonstrate sound judgement in terms of handling complex, confidential, and regulated information\r\n \r\nTravel up to 20% domestically and internationally for scientific meetings.\r\nSalary range: $265-295K/year\r\nBenefits\r\n 401(k) plan with company match \r\n Medical, dental, and vision plans \r\n Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance \r\n Company-provided short and long-term disability benefits \r\n Unique offerings of Pet Insurance and Legal Insurance\r\n Employee Assistance Program\r\n Employee Discounts\r\n Professional Development\r\n Health Saving Account (HSA)\r\n Flexible Spending Accounts\r\n Various incentive compensation plans\r\n Accident, Critical Illness, and Hospital Indemnity Insurance \r\n Mental Health resources \r\n Paid leave benefits for new parents \r\n \r\nA note to recruiters:\r\nWe do not allow external search party solicitation. 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Our award-winning products help our global community with daily insights to inspire healthy lifestyles. We've helped millions of people understand and improve their health.\r\nAt Oura we are building a complete platform for preventative health, from sleep optimization to metabolic health, women’s health, stress management and heart health tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a technology product. \r\nFor us, empowering the world starts with living our values and empowering our team. As a quickly growing company we work to ensure that our team members have what they need to do their best work — both in and out of the office.\r\nWe are looking for a Director, Regulatory Affairs and Quality Assurance to play a key role in shaping Oura’s future products and services.\r\nWhat you will do:\r\n Lead regulatory and quality strategy for product development, approval, and lifecycle management for all regulated features.\r\n Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.\r\n Review marketing and promotional materials for regulated and general wellness features.\r\n Serve as the primary liaison with regulatory agencies and notified bodies.\r\n Guide the creation and submission of regulatory filings including 510(k)s, De Novo submissions, and international registrations.\r\n Partner with science, data science, engineering, clinical, marketing, and legal teams to integrate regulatory requirements into product design and development, including clinical evidence strategy.\r\n Oversee post-market surveillance, adverse event reporting, and regulatory audits.\r\n Build and manage the RA/QA team, including hiring, mentoring, and performance development.\r\n Monitor regulatory changes and trends, advising the executive team on potential business impacts.\r\n Ensure an effective Quality Management System (QMS).\r\n This is a remote US role.\r\n\r\nRequirements\r\nWe would love to have you on our team if you have:\r\n Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred.\r\n 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred.\r\n Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.\r\n Proven track record of successful management of a quality system, including external audits.\r\n Deep understanding of software as a medical device (SaMD) and cybersecurity regulations.\r\n Experience with privacy and data regulations (e.g., HIPAA, GDPR).\r\n Excellent leadership, communication, and stakeholder management skills.\r\n Ability to thrive in a fast-paced, dynamic startup environment.\r\n Benefits\r\nAt Oura, we care about you and your well-being. What we offer:\r\n Competitive salary and equity packages\r\n Health, dental, vision insurance, and mental health resources\r\n An Oura Ring of your own plus employee discounts for friends & family\r\n 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off\r\n Paid sick leave and parental leave\r\n \r\nOura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates’ pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.\r\n\r\n Region 1: $206,000 - $257,000\r\n Region 2: $190,000 - $237,000\r\n Region 3: $178,000 - $223,000 \r\n \r\nA recruiter can determine your zones/tiers based on your US location.\r\nWe are not considering candidates residing in the following states: Alaska (AK), Arkansas (AR), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode Island (RI), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI)\r\n\r\nOura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.\r\n\r\nWe will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.\r\nDisclaimer: Beware of fake job offers!\r\nWe’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note:\r\n Our jobs are listed only on the ŌURA Careers page and trusted job boards.\r\n We will never ask for personal information like ID or payment for equipment upfront.\r\n Official offers are sent through Docusign after a verbal offer, not via text or email.\r\n Stay cautious and protect your personal details.\r\nTo all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.\r\n\r\n","price":"$206,000-257,000/year","unit":"per year","currency":null,"company":"Workable","language":"en","online":1,"infoType":1,"biz":"jobs","postDate":"1756712150000","seoName":"director-regulatory-affairs-and-quality-assurance","supplement":null,"author":null,"originalPrice":null,"soldCnt":null,"topSeller":null,"source":1,"cardType":null,"action":"https://us.ok.com/city-alameda/cate-management8/director-regulatory-affairs-and-quality-assurance-6349981625356912/","localIds":"116","cateId":null,"tid":null,"logParams":{"tid":"3c1bc9c2-c44b-4e33-b41c-ff2f9d9c04aa","sid":"1edd0e9e-9f52-483a-b2a9-a4a05e0a53ec"},"attrParams":{"summary":null,"highLight":["Lead regulatory strategy for health products","Ensure FDA and CE compliance","Manage RA/QA team"],"employment":[{"icon":"https://sgj1.ok.com/yongjia/bkimg/8hvituaa__w72_h72.webp","name":"Job Type","value":"Full-time","unit":null}]},"isFavorite":false},{"category":"4000,4182,4190","location":"Palo Alto, CA, USA","infoId":"6349991733261112","pictureUrl":"https://uspic1.ok.com/post/image/fc2dfa4f-dccd-4b5b-b64c-e4037dc4d35f.jpg","title":"Head of ICSR Management - Job ID: 1598","content":"Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.\r\nHere at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.\r\nGuided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.\r\nOur culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.\r\nThe Head of ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head, Global PV Operations, Head of ICSR Management Team is responsible for the oversight of all ICSR Management activities including ICSR processing workflow management, submission and follow-up activities. He/She is responsible for the leadership and management of the strategic and operational job activities pertaining to the ICSR Management team.\r\n\r\nKey Responsibilities\r\n People Management: Establish and manage a team of ICSR Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to.\r\n Responsible for managerial oversight of the ICSR Management team with regards to budget, headcount, people and organizational development.\r\n Participates with senior management to establish strategic plans and objectives.\r\n Acts as an integral member of the Global Patient Safety (GPS) leadership team.\r\n Works closely with the Head, Global PV Operations to be aware of all safety issues/concerns and provide consultation when needed.\r\n Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products.\r\n Ensures that all safety reports received from any source for Ascendis Products are processed in the safety database and are reported according to ICH-GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business Partner agreements.\r\n Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assists in the oversight of the PV Vendor processing ICSRs for Ascendis Products.\r\n Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable. Coordinates follow up activities for missing or ambiguous safety information as appropriate.\r\n Support vendor oversight by monitoring performance metrics/KPIs.\r\n Provides input to assigned vendors to improve the quality of Adverse Event intake.\r\n Performs late case investigation and risk mitigation strategy. Ability to review late case(s) to determine Root Cause Analysis (RCA) and create Corrective Action and Preventative action (CAPA) as applicable.\r\n Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and submission to Health Authorities or partners as applicable.\r\n Ensure any non-compliance or late ICSR are identified and ensure deviations are filed in accordance with Ascendis requirements.\r\n Accountable for the data integrity of safety data outputs from the Safety Database for aggregate reports, Health Authority requests or other safety requirements.\r\n Liaise with other functional groups for implementation of PV related processes requiring cross functional collaboration.\r\n Drafts and updates departmental SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations.\r\n Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)\r\n Responsible for training GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety.\r\n Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable.\r\n Identify opportunities for process improvements and participate in process optimization initiatives.\r\n Support Medical Safety Science team with activities related to signal detection, risk management and health authority responses as needed.\r\n Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required.\r\n Supports Case Transmission Verification (CTV) and SAE Reconciliation activities as needed.\r\n Collaborate with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database.\r\n Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure appropriate safety exchange requirements are established and adhered to.\r\n Responsible for the creation, maintenance and implementation of the Business Continuity Plan (BCP ) as needed.\r\n \r\nAdditional activities may include but are not limited to:\r\n Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)\r\n Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits\r\n Work collaboratively with Vendor Management, PV Study Management, QPPV Office and Medical Safety Science teams for assigned activities\r\n Is responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary\r\n Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR management (example: Local PV agreements, CRMs, Digital Media etc.)\r\n Participate in relevant crisis management activities within the scope of Ascendis PV group \r\n \r\nCompetencies Identified for success:\r\n Works effectively, independently, and collaboratively\r\n Strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment\r\n Demonstrates ownership, initiative, and accountability\r\n Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting\r\n Excellent communication skills, both written and verbal, with credibility and confidence \r\n Sound strategic evaluation, analysis, and decision-making skills as demonstrated in effective strategy formulation, tactics, and action plans to achieve results\r\n Displays a high level of commitment\r\n \r\nSalary Range: $220-245K DOE \r\n\r\nA note to recruiters:\r\nWe do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.\r\nRequirements\r\n Health Care Professional degree required (e.g., B. Pharm, PharmD, RN etc.)\r\n Candidates with advanced scientific degrees and extensive drug safety experience is highly desired.\r\n Minimum of 10 years recent experience in Pharmacovigilance.\r\n Minimum of 5 years of people management experience (preferred).\r\n Working knowledge of validated Drug Safety Databases (Argus preferred)\r\n Experience with MedDRA coding and global safety reporting regulatory requirements.\r\n Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.\r\n Ability to travel up to 20% of the time domestically and internationally\r\n Benefits\r\n 401(k) plan with company match \r\n Medical, dental, and vision plans \r\n Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance \r\n Company-provided short and long-term disability benefits \r\n Unique offerings of Pet Insurance and Legal Insurance\r\n Employee Assistance Program\r\n Employee Discounts\r\n Professional Development\r\n Health Saving Account (HSA)\r\n Flexible Spending Accounts\r\n Various incentive compensation plans\r\n Accident, Critical Illness, and Hospital Indemnity Insurance \r\n Mental Health resources \r\n Paid leave benefits for new parents \r\n ","price":"$220,000-245,000/year","unit":"per year","currency":null,"company":"Workable","language":"en","online":1,"infoType":1,"biz":"jobs","postDate":"1756710757000","seoName":"head-of-icsr-management-job-id-1598","supplement":null,"author":null,"originalPrice":null,"soldCnt":null,"topSeller":null,"source":1,"cardType":null,"action":"https://us.ok.com/city-alameda/cate-management8/head-of-icsr-management-job-id-1598-6349991733261112/","localIds":"11037","cateId":null,"tid":null,"logParams":{"tid":"9e995b3a-0324-412a-9d36-1654bf527ea0","sid":"1edd0e9e-9f52-483a-b2a9-a4a05e0a53ec"},"attrParams":{"summary":null,"highLight":["Lead ICSR Management Team","Ensure compliance with PV regulations","Strategic oversight of safety reporting"],"employment":[{"icon":"https://sgj1.ok.com/yongjia/bkimg/8hvituaa__w72_h72.webp","name":"Job Type","value":"Full-time","unit":null}]},"isFavorite":false},{"category":"4000,4182,4190","location":"Hayward, CA, USA","infoId":"6349992032627312","pictureUrl":"https://uspic1.ok.com/post/image/fc2dfa4f-dccd-4b5b-b64c-e4037dc4d35f.jpg","title":"Women's Health Manager","content":"Under the supervision of the Associate Director of Clinical Services, the Women’s Health Manager oversees the Comprehensive Perinatal Services Program (CPSP) and leads the Women’s Health (WH) service line at Tiburcio Vasquez Health Center, Inc. (TVHC). This role is responsible for strategic program planning, implementation, evaluation, and quality assurance to ensure the delivery of high-quality, patient-centered care.\r\nThe Women’s Health Manager directly supervises the CPSP staff and collaborates across departments, working closely with providers, nursing teams, operations, business development, the Social Determinants of Health (SDOH) team, and community partners. Through a cross-functional approach, this position drives the continuous improvement and expansion of women’s health services to meet the needs of TVHC’s diverse patient population.\r\nAbout Us: Tiburcio Vasquez Health Center is a non-profit community health center that is dedicated to promoting the health and well-being of our community by providing accessible, high quality care by integrating primary care, dental care, WIC support, mental health counseling, community health education and more.\r\nCompensation: $76,530.94 - $84,927.20 annually, depending on experience.\r\nTVHC offers compensation ranges that are determined by a thorough market-based analysis and are fully disclosed in accordance with California law. The pay for a selected candidate is determined by a variety of factors to ensure fair and equitable compensation. These factors include the candidate's experience, education, skills, training, licensure, certifications, and the specific scope of the role. We are committed to providing a competitive compensation package that extends beyond base salary, designed to support the health, wealth, and career development of our employees.\r\nResponsibilities: \r\n Remains current on regulatory requirements and best practices related to Women’s Health/Perinatal care in particular the Comprehensive Perinatal Support Program (CPSP).\r\n Lead program planning, execution, and evaluation to enhance service delivery and patient care.\r\n Facilitate care coordination meetings with CPSP, Operations, and Medical Services teams.\r\n Conduct audits and quality reviews to ensure compliance with regulatory standards and improve patient services.\r\n Develop and maintain a CPSP training curriculum for staff and adjacent support teams, ensuring compliance with job expectations and productivity standards.\r\n Oversee and facilitate staff training and development related to Perinatal care and regulatory requirements.\r\n Manage TVHC’s Centering Program, coordinating group prenatal services and promoting patient engagement.\r\n Track, analyze, and manage data and reporting metrics required by county CPSP, active grants, and TVHC quality projects.\r\n Ensure compliance with billing, documentation, and clinical workflows, collaborating with TVHC leaders.\r\n Work with the Population Health team to leverage data insights for improved patient outcomes.\r\n Collaborate with WIC, Family Support Services (FSS), and clinic leadership to enhance Women’s Health services.\r\n Support the transition of newborns into Pediatric care, ensuring continuity of services.\r\n Maintain and develop patient education materials, aligning with best practices and regulatory standards.\r\n Works in conjunction with HR to address staffing and hiring needs and manage employee performance.\r\n Attends all appropriate clinic staff meetings to coordinate program activities.\r\n Manage CPSP staff scheduling, including coverage, training coordination, and EMR/EPIC functions.\r\n Promote a team-based approach to obstetric and gynecological care, including case conferences.\r\n Act as a TVHC liaison with community partners, hospitals, and external agencies.\r\n Represent TVHC in local, county, regional, and statewide meetings, committees, and conferences.\r\n Adhere to and promote TVHC’s Service Excellence Standards in all responsibilities.\r\n Perform other duties as assigned by leadership.\r\n Requirements\r\n Excellent organizational and time management skills, with the ability to prioritize multiple projects while ensuring quality service and business outcomes.\r\n Proven ability to establish and maintain effective working relationships with employees, peers, and leadership to support business objectives.\r\n Proficiency in Microsoft Office Suite (PowerPoint, Word, Excel, Outlook), Tableau, email communication, and other essential software/applications relevant to the role.\r\n Strong presentation skills, with the ability to effectively organize and present information in both formal and informal group settings.\r\n Sound judgment and discretion in making programmatic decisions.\r\n Ability to travel to designated locations needed.\r\n Qualifications:\r\n Associate’s degree (AA) in Nursing, Public Health, Health Administration, Social Work, or a related field required (or six years of experience in Women’s Health, Perinatal care, or a related area).\r\n Licensed Vocational Nurse (LVN) license preferred but not required, with at least two years of clinical experience.\r\n Minimum of two (2) years of experience in maternal & child Health, health education, or community outreach required.\r\n Minimum of three (3) or more years of supervisory experience required. \r\n Experience in project planning, leadership, and implementation preferred. \r\n Benefits\r\nWe offer excellent benefits including: medical (100% paid co-payments, premiums, etc.), dental, vision (including dependent and domestic partner coverage), generous paid leave benefits including holidays, Flexible Spending Accounts, retirement plans with an Employer match, tuition reimbursement, monthly treats, pet insurance, and more.\r\n","price":"$76,530.94-84,927.2","unit":null,"currency":null,"company":"Workable","language":"en","online":1,"infoType":1,"biz":"jobs","postDate":"1756093127000","seoName":"women-s-health-manager","supplement":null,"author":null,"originalPrice":null,"soldCnt":null,"topSeller":null,"source":1,"cardType":null,"action":"https://us.ok.com/city-alameda/cate-management8/women-s-health-manager-6349992032627312/","localIds":"863","cateId":null,"tid":null,"logParams":{"tid":"1a4f7a0d-03f2-4640-a840-103f43f75f74","sid":"1edd0e9e-9f52-483a-b2a9-a4a05e0a53ec"},"attrParams":{"summary":null,"employment":[{"icon":"https://sgj1.ok.com/yongjia/bkimg/8hvituaa__w72_h72.webp","name":"Job Type","value":"Full-time","unit":null}]},"isFavorite":false},{"category":"4000,4182,4190","location":"Hayward, CA, USA","infoId":"6349991819366712","pictureUrl":"https://uspic1.ok.com/post/image/fc2dfa4f-dccd-4b5b-b64c-e4037dc4d35f.jpg","title":"Associate Medical Director, Women's Health (CNM, NP or PA)","content":"At Tiburcio Vasquez Health Center (TVHC), we’re dedicated to delivering patient-centered, value-based care to our diverse, multilingual community. You’ll collaborate with a multidisciplinary team to provide culturally sensitive, high-quality care in an outpatient setting. If you’re passionate about making a meaningful impact in community health, TVHC is the place for you!\r\n\r\nAbout Us: TVHC is a mission-driven, non-profit Federally Qualified Health Center (FQHC) dedicated to improving the health and well-being of the communities we serve. We offer comprehensive, accessible care through an integrated model that includes primary care, dental services, WIC support, mental health counseling, community health education, and more!\r\n\r\nWe are seeking an Associate Medical Director (CNM, NP or PA) to provide clinical leadership and oversight for our Women's Health department. Reporting directly to the Chief Medical Officer (CMO), the AMD will play a key role in supervising day-to-day care delivery, supporting clinical staff, and fostering a culture of high-quality, equitable healthcare.\r\nThe schedule includes:\r\n 1 day of clinical leadership providing department and personnel oversight\r\n 4 days providing clinical care to patients\r\n Compensation: $69.39 - $82.86 per hour / $144,331.20 - $172,348.80 salary, with an additional $20,000 per year leadership stipend, and a signing bonus available!\r\nTVHC offers compensation ranges that are fully disclosed in accordance with California law. The pay for a selected candidate is determined by a variety of factors to ensure fair and equitable compensation. We are committed to providing a competitive compensation package that extends beyond base salary, designed to support the health, wealth, and career development of our employees.\r\nLoan repayment/forgiveness candidacy is available. Our service area qualifies as a Medically Underserved Area (MUA) and a Health Professional Shortage Area (HPSA) through the National Health Service Corp (NHSC) loan repayment program. To learn more, visit the following link: \r\nResponsibilities: \r\n Manages administrative responsibilities such as effective integration and coordination of the clinical services department; scheduling and conducting departmental staff meetings, orienting, and mentoring new providers; ensuring clinical staff is updated and/or trained to standards\r\n Utilizes department and individual-specific data and dashboards to guide operational and clinical excellence\r\n Supervises, mentors, coaches, and develops clinicians utilizing qualitative and quantitative data\r\n Develops educational programming and support as assigned\r\n Participates in the recruitment, hiring, corrective action counseling and terminations as needed\r\n Responsible for peer review process and performance review for direct reports. \r\n Supports the Physicians and NP/PA/CNM’s in the accurate and timely completion of documentation and follow-up tasks\r\n Assumes clinical responsibility in conjunction with the Chief Medical Officer. Provides regular, ongoing, and special reporting in functional areas. Facilitates monthly department meeting in support and alignment with the mission, vision and values of the organization\r\n Fosters an environment that promotes TVHC’s Quality Initiatives and supports removing barriers to achieving quality in medical care. Promotes a positive working culture and actively engages in constructive problem solving. This includes the development of clinical pathways to reduce unwarranted practice variation\r\n Performs health assessments, including a thorough history and physical examination, ordering or performing certain diagnostic tests, medication orders, evaluation of the psychosocial and family aspects of the situation sufficient to make a general health assessment, and diagnose the nature of common acute and chronic conditions, and any necessary follow-up care.\r\n Provides direct clinical medical services in the area of board certified (or board eligible) medical specialty in accordance with the highest applicable standards of medical and professional practice and in full accordance with health center protocols, policies and Job Description, Associate Medical Director.\r\n Provides leadership, vision, and direction of the department, including assisting in formulation and/or revision of medical program/clinical services policies and protocols.\r\n Assist in the design, implementation, and evaluation of TVHC’s clinical programs. Assist in planning and supervising new technologies and programs. Works collaboratively with other departments for the successful integration of services as appropriate.\r\n Assumes other responsibilities at the direction of the Chief Medical Officer including but not limited to staff performance evaluations, monitoring providers’ PAQs. \r\n Demonstrates commitment to, and understanding of, TVHC’s Service Excellence Standards, by modeling service excellence in all internal and external relationships, addressing service excellence deficits in staff, and in performance of all duties and responsibilities of this position.\r\n In the absence of CMO, or when directed by the CEO or Designee: may be asked to assume responsibilities and authorities of Chief Medical Officer, on an interim basis as required to ensure regulatory compliance and the ongoing clinic operations of TVHC.\r\n Collaborates with Management Team members, as directed, to develop strategies and policies and provides consultation within scope of responsibility.\r\n Performs other related duties as may be assigned by Chief Medical Officer and or Chief Executive Officer.\r\n Requirements\r\nMust have license as an NP, CNM or PA, and board certification or eligibility within discipline required.\r\n Current, valid license to practice medicine in the State of California, including DEA license (if applicable) and CPR required.\r\n Minimum three (3) years of clinical experience required.\r\n Minimum two (2) years of experience supervising providers and other clinical staff preferred.\r\n Experience in underserved communities or in a community health center setting preferred. \r\n Qualifications: \r\n Proficiency in clinical practice within the specified medical specialty.\r\n For MDs or DOs, a willingness to collaborate with and provide supervision to NP/PA/CNM providers as required.\r\n Ability to travel to designated locations as required by supervisor. \r\n Demonstrated ability to work effectively independently and as part of a team, in collaborative settings, required.\r\n Excellent written and verbal communication skills required.\r\n Understands and is committed to maintaining highest level of confidentiality.\r\n Demonstrated ability to provide leadership to staff and build the trust and respect of patients, staff, colleagues, and external contacts.\r\n Commitment to remaining up-to-date with evidence-based, best practices in internal medicine and community-based medicine\r\n Willingness and ability to work some evenings and weekends, as needed.\r\n Ability to utilize computer technology preferred, and willingness to develop and adapt to the evolving technological requirements of modern medical health center practices required.\r\n Demonstrates flexibility regarding job duties and assignments.\r\n Benefits\r\nHealth & Wellness\r\n Medical: 100% employer-paid co-payments, prescriptions, and premiums\r\n Dental & Vision Coverage: employer-paid premiums\r\n Life Insurance\r\n Pet Insurance\r\n Short-Term and Long-Term Disability\r\n Chiropractic/Acupuncture: 100% employer-paid\r\n Employee Assistance Program (EAP)\r\n Financial Benefits\r\n Retirement Plan with Matching!\r\n Guaranteed Salary Increases\r\n Flexible Spending Accounts: Healthcare & Dependent Care\r\n NHSC/HRSA Loan Repayment Eligibility\r\n Visa Assistance\r\n Commuter Benefits\r\n Scrub Allowance \r\n Paid Time Off & Leave\r\n Generous Paid Time Off for Vacation & Sick\r\n 13 Paid Holidays\r\n Educational Leave\r\n Travel Assistance Program\r\n Professional Development & Career Growth\r\n Tuition Reimbursement\r\n Continuing Education Reimbursement\r\n Scholarship Program\r\n Professional Membership Reimbursement\r\n Career Growth Opportunities\r\n EPIC Superusers\r\n Recognition Programs\r\n Work Environment & Perks\r\n Dragon Ambient Experience (DAX) AI Clinical Documentation\r\n Malpractice Insurance Covered\r\n Monthly Treats\r\n Bilingual Medical Assistants\r\n Employee Discounts\r\n Employee Referral Program\r\n 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Location:
Alameda
Category:
Management

Workable
Medical Director, Clinical Development - Job: MDCD
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
The Medical Director is involved in the design, monitoring, data analysis, and interpretation of the Company’s late-phase clinical trials in endocrinology. As such, the Medical Director is an important and visible member of the clinical development team. The Medical Director position is based in the United States (preferably in Palo Alto, California) and will report to the Vice President, Clinical Science.
Key Responsibilities
Contribute to formulation and implementation of the Clinical Development Plan
Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program
For clinical trials: design, provide overall oversight, and support site and subject retention
Serve as a Medical Monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy data
Provide leadership to teams of medical monitors
Provide leadership to study teams
Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
Ensure study integrity, and track accumulating safety and efficacy data
Analyze, evaluate, interpret, and report clinical data
Anticipate and solve complex drug development problems
Contribute to regulatory strategy
Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions
Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
Collaborate with—and serve as a clinical research resource for—cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development
Contribute to (and may be asked to represent the clinical development department in) corporate strategic and organizational initiatives
Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
Assist in portfolio management and commercial activities as needed
Complete assigned tasks thoroughly, accurately, and on time
Adhere to rigorous ethical standards
Requirements
Knowledge, Skills and Experience
M.D. degree
Completion of ACGME-accredited residency and fellowship (strongly preferred)
Physician licensure in at least one state (strongly preferred)
Board-certified (strongly preferred), with specialty in endocrinology highly desired
At least 5 years of industry experience (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis). Those with less experience may be considered for an Associate Medical Director position.
At least 3 years of experience with clinical trial design and execution
Strong track record of scientific and clinical inquiry
Possess excellent communication skills (written and oral)
Learn quickly, follow complex directions under pressure
Multi-task while remaining organized and attentive to detail
Lead both directly and by example
Work hard, be a trustworthy and collaborative team player
Take initiative and solve complex problems
Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
Travel up to 20% domestically and internationally for scientific meetings.
Salary range: $265-295K/year
Benefits
401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Palo Alto, CA, USA
$265,000-295,000/year

Workable
Director, Regulatory Affairs and Quality Assurance
Our mission at Oura is to make health a daily practice, empowering every person to own their inner potential. Our award-winning products help our global community with daily insights to inspire healthy lifestyles. We've helped millions of people understand and improve their health.
At Oura we are building a complete platform for preventative health, from sleep optimization to metabolic health, women’s health, stress management and heart health tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a technology product.
For us, empowering the world starts with living our values and empowering our team. As a quickly growing company we work to ensure that our team members have what they need to do their best work — both in and out of the office.
We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key role in shaping Oura’s future products and services.
What you will do:
Lead regulatory and quality strategy for product development, approval, and lifecycle management for all regulated features.
Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.
Review marketing and promotional materials for regulated and general wellness features.
Serve as the primary liaison with regulatory agencies and notified bodies.
Guide the creation and submission of regulatory filings including 510(k)s, De Novo submissions, and international registrations.
Partner with science, data science, engineering, clinical, marketing, and legal teams to integrate regulatory requirements into product design and development, including clinical evidence strategy.
Oversee post-market surveillance, adverse event reporting, and regulatory audits.
Build and manage the RA/QA team, including hiring, mentoring, and performance development.
Monitor regulatory changes and trends, advising the executive team on potential business impacts.
Ensure an effective Quality Management System (QMS).
This is a remote US role.
Requirements
We would love to have you on our team if you have:
Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred.
8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred.
Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.
Proven track record of successful management of a quality system, including external audits.
Deep understanding of software as a medical device (SaMD) and cybersecurity regulations.
Experience with privacy and data regulations (e.g., HIPAA, GDPR).
Excellent leadership, communication, and stakeholder management skills.
Ability to thrive in a fast-paced, dynamic startup environment.
Benefits
At Oura, we care about you and your well-being. What we offer:
Competitive salary and equity packages
Health, dental, vision insurance, and mental health resources
An Oura Ring of your own plus employee discounts for friends & family
20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
Paid sick leave and parental leave
Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates’ pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.
Region 1: $206,000 - $257,000
Region 2: $190,000 - $237,000
Region 3: $178,000 - $223,000
A recruiter can determine your zones/tiers based on your US location.
We are not considering candidates residing in the following states: Alaska (AK), Arkansas (AR), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode Island (RI), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI)
Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.
We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Disclaimer: Beware of fake job offers!
We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note:
Our jobs are listed only on the ŌURA Careers page and trusted job boards.
We will never ask for personal information like ID or payment for equipment upfront.
Official offers are sent through Docusign after a verbal offer, not via text or email.
Stay cautious and protect your personal details.
To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.

San Francisco, CA, USA
$206,000-257,000/year

Workable
Head of ICSR Management - Job ID: 1598
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
The Head of ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head, Global PV Operations, Head of ICSR Management Team is responsible for the oversight of all ICSR Management activities including ICSR processing workflow management, submission and follow-up activities. He/She is responsible for the leadership and management of the strategic and operational job activities pertaining to the ICSR Management team.
Key Responsibilities
People Management: Establish and manage a team of ICSR Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to.
Responsible for managerial oversight of the ICSR Management team with regards to budget, headcount, people and organizational development.
Participates with senior management to establish strategic plans and objectives.
Acts as an integral member of the Global Patient Safety (GPS) leadership team.
Works closely with the Head, Global PV Operations to be aware of all safety issues/concerns and provide consultation when needed.
Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products.
Ensures that all safety reports received from any source for Ascendis Products are processed in the safety database and are reported according to ICH-GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business Partner agreements.
Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assists in the oversight of the PV Vendor processing ICSRs for Ascendis Products.
Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable. Coordinates follow up activities for missing or ambiguous safety information as appropriate.
Support vendor oversight by monitoring performance metrics/KPIs.
Provides input to assigned vendors to improve the quality of Adverse Event intake.
Performs late case investigation and risk mitigation strategy. Ability to review late case(s) to determine Root Cause Analysis (RCA) and create Corrective Action and Preventative action (CAPA) as applicable.
Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and submission to Health Authorities or partners as applicable.
Ensure any non-compliance or late ICSR are identified and ensure deviations are filed in accordance with Ascendis requirements.
Accountable for the data integrity of safety data outputs from the Safety Database for aggregate reports, Health Authority requests or other safety requirements.
Liaise with other functional groups for implementation of PV related processes requiring cross functional collaboration.
Drafts and updates departmental SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations.
Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
Responsible for training GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety.
Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable.
Identify opportunities for process improvements and participate in process optimization initiatives.
Support Medical Safety Science team with activities related to signal detection, risk management and health authority responses as needed.
Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required.
Supports Case Transmission Verification (CTV) and SAE Reconciliation activities as needed.
Collaborate with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database.
Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure appropriate safety exchange requirements are established and adhered to.
Responsible for the creation, maintenance and implementation of the Business Continuity Plan (BCP ) as needed.
Additional activities may include but are not limited to:
Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
Work collaboratively with Vendor Management, PV Study Management, QPPV Office and Medical Safety Science teams for assigned activities
Is responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary
Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR management (example: Local PV agreements, CRMs, Digital Media etc.)
Participate in relevant crisis management activities within the scope of Ascendis PV group
Competencies Identified for success:
Works effectively, independently, and collaboratively
Strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment
Demonstrates ownership, initiative, and accountability
Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
Excellent communication skills, both written and verbal, with credibility and confidence
Sound strategic evaluation, analysis, and decision-making skills as demonstrated in effective strategy formulation, tactics, and action plans to achieve results
Displays a high level of commitment
Salary Range: $220-245K DOE
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Requirements
Health Care Professional degree required (e.g., B. Pharm, PharmD, RN etc.)
Candidates with advanced scientific degrees and extensive drug safety experience is highly desired.
Minimum of 10 years recent experience in Pharmacovigilance.
Minimum of 5 years of people management experience (preferred).
Working knowledge of validated Drug Safety Databases (Argus preferred)
Experience with MedDRA coding and global safety reporting regulatory requirements.
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
Ability to travel up to 20% of the time domestically and internationally
Benefits
401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents

Palo Alto, CA, USA
$220,000-245,000/year

Workable
Women's Health Manager
Under the supervision of the Associate Director of Clinical Services, the Women’s Health Manager oversees the Comprehensive Perinatal Services Program (CPSP) and leads the Women’s Health (WH) service line at Tiburcio Vasquez Health Center, Inc. (TVHC). This role is responsible for strategic program planning, implementation, evaluation, and quality assurance to ensure the delivery of high-quality, patient-centered care.
The Women’s Health Manager directly supervises the CPSP staff and collaborates across departments, working closely with providers, nursing teams, operations, business development, the Social Determinants of Health (SDOH) team, and community partners. Through a cross-functional approach, this position drives the continuous improvement and expansion of women’s health services to meet the needs of TVHC’s diverse patient population.
About Us: Tiburcio Vasquez Health Center is a non-profit community health center that is dedicated to promoting the health and well-being of our community by providing accessible, high quality care by integrating primary care, dental care, WIC support, mental health counseling, community health education and more.
Compensation: $76,530.94 - $84,927.20 annually, depending on experience.
TVHC offers compensation ranges that are determined by a thorough market-based analysis and are fully disclosed in accordance with California law. The pay for a selected candidate is determined by a variety of factors to ensure fair and equitable compensation. These factors include the candidate's experience, education, skills, training, licensure, certifications, and the specific scope of the role. We are committed to providing a competitive compensation package that extends beyond base salary, designed to support the health, wealth, and career development of our employees.
Responsibilities:
Remains current on regulatory requirements and best practices related to Women’s Health/Perinatal care in particular the Comprehensive Perinatal Support Program (CPSP).
Lead program planning, execution, and evaluation to enhance service delivery and patient care.
Facilitate care coordination meetings with CPSP, Operations, and Medical Services teams.
Conduct audits and quality reviews to ensure compliance with regulatory standards and improve patient services.
Develop and maintain a CPSP training curriculum for staff and adjacent support teams, ensuring compliance with job expectations and productivity standards.
Oversee and facilitate staff training and development related to Perinatal care and regulatory requirements.
Manage TVHC’s Centering Program, coordinating group prenatal services and promoting patient engagement.
Track, analyze, and manage data and reporting metrics required by county CPSP, active grants, and TVHC quality projects.
Ensure compliance with billing, documentation, and clinical workflows, collaborating with TVHC leaders.
Work with the Population Health team to leverage data insights for improved patient outcomes.
Collaborate with WIC, Family Support Services (FSS), and clinic leadership to enhance Women’s Health services.
Support the transition of newborns into Pediatric care, ensuring continuity of services.
Maintain and develop patient education materials, aligning with best practices and regulatory standards.
Works in conjunction with HR to address staffing and hiring needs and manage employee performance.
Attends all appropriate clinic staff meetings to coordinate program activities.
Manage CPSP staff scheduling, including coverage, training coordination, and EMR/EPIC functions.
Promote a team-based approach to obstetric and gynecological care, including case conferences.
Act as a TVHC liaison with community partners, hospitals, and external agencies.
Represent TVHC in local, county, regional, and statewide meetings, committees, and conferences.
Adhere to and promote TVHC’s Service Excellence Standards in all responsibilities.
Perform other duties as assigned by leadership.
Requirements
Excellent organizational and time management skills, with the ability to prioritize multiple projects while ensuring quality service and business outcomes.
Proven ability to establish and maintain effective working relationships with employees, peers, and leadership to support business objectives.
Proficiency in Microsoft Office Suite (PowerPoint, Word, Excel, Outlook), Tableau, email communication, and other essential software/applications relevant to the role.
Strong presentation skills, with the ability to effectively organize and present information in both formal and informal group settings.
Sound judgment and discretion in making programmatic decisions.
Ability to travel to designated locations needed.
Qualifications:
Associate’s degree (AA) in Nursing, Public Health, Health Administration, Social Work, or a related field required (or six years of experience in Women’s Health, Perinatal care, or a related area).
Licensed Vocational Nurse (LVN) license preferred but not required, with at least two years of clinical experience.
Minimum of two (2) years of experience in maternal & child Health, health education, or community outreach required.
Minimum of three (3) or more years of supervisory experience required.
Experience in project planning, leadership, and implementation preferred.
Benefits
We offer excellent benefits including: medical (100% paid co-payments, premiums, etc.), dental, vision (including dependent and domestic partner coverage), generous paid leave benefits including holidays, Flexible Spending Accounts, retirement plans with an Employer match, tuition reimbursement, monthly treats, pet insurance, and more.

Hayward, CA, USA
$76,530.94-84,927.2

Workable
Associate Medical Director, Women's Health (CNM, NP or PA)
At Tiburcio Vasquez Health Center (TVHC), we’re dedicated to delivering patient-centered, value-based care to our diverse, multilingual community. You’ll collaborate with a multidisciplinary team to provide culturally sensitive, high-quality care in an outpatient setting. If you’re passionate about making a meaningful impact in community health, TVHC is the place for you!
About Us: TVHC is a mission-driven, non-profit Federally Qualified Health Center (FQHC) dedicated to improving the health and well-being of the communities we serve. We offer comprehensive, accessible care through an integrated model that includes primary care, dental services, WIC support, mental health counseling, community health education, and more!
We are seeking an Associate Medical Director (CNM, NP or PA) to provide clinical leadership and oversight for our Women's Health department. Reporting directly to the Chief Medical Officer (CMO), the AMD will play a key role in supervising day-to-day care delivery, supporting clinical staff, and fostering a culture of high-quality, equitable healthcare.
The schedule includes:
1 day of clinical leadership providing department and personnel oversight
4 days providing clinical care to patients
Compensation: $69.39 - $82.86 per hour / $144,331.20 - $172,348.80 salary, with an additional $20,000 per year leadership stipend, and a signing bonus available!
TVHC offers compensation ranges that are fully disclosed in accordance with California law. The pay for a selected candidate is determined by a variety of factors to ensure fair and equitable compensation. We are committed to providing a competitive compensation package that extends beyond base salary, designed to support the health, wealth, and career development of our employees.
Loan repayment/forgiveness candidacy is available. Our service area qualifies as a Medically Underserved Area (MUA) and a Health Professional Shortage Area (HPSA) through the National Health Service Corp (NHSC) loan repayment program. To learn more, visit the following link:
Responsibilities:
Manages administrative responsibilities such as effective integration and coordination of the clinical services department; scheduling and conducting departmental staff meetings, orienting, and mentoring new providers; ensuring clinical staff is updated and/or trained to standards
Utilizes department and individual-specific data and dashboards to guide operational and clinical excellence
Supervises, mentors, coaches, and develops clinicians utilizing qualitative and quantitative data
Develops educational programming and support as assigned
Participates in the recruitment, hiring, corrective action counseling and terminations as needed
Responsible for peer review process and performance review for direct reports.
Supports the Physicians and NP/PA/CNM’s in the accurate and timely completion of documentation and follow-up tasks
Assumes clinical responsibility in conjunction with the Chief Medical Officer. Provides regular, ongoing, and special reporting in functional areas. Facilitates monthly department meeting in support and alignment with the mission, vision and values of the organization
Fosters an environment that promotes TVHC’s Quality Initiatives and supports removing barriers to achieving quality in medical care. Promotes a positive working culture and actively engages in constructive problem solving. This includes the development of clinical pathways to reduce unwarranted practice variation
Performs health assessments, including a thorough history and physical examination, ordering or performing certain diagnostic tests, medication orders, evaluation of the psychosocial and family aspects of the situation sufficient to make a general health assessment, and diagnose the nature of common acute and chronic conditions, and any necessary follow-up care.
Provides direct clinical medical services in the area of board certified (or board eligible) medical specialty in accordance with the highest applicable standards of medical and professional practice and in full accordance with health center protocols, policies and Job Description, Associate Medical Director.
Provides leadership, vision, and direction of the department, including assisting in formulation and/or revision of medical program/clinical services policies and protocols.
Assist in the design, implementation, and evaluation of TVHC’s clinical programs. Assist in planning and supervising new technologies and programs. Works collaboratively with other departments for the successful integration of services as appropriate.
Assumes other responsibilities at the direction of the Chief Medical Officer including but not limited to staff performance evaluations, monitoring providers’ PAQs.
Demonstrates commitment to, and understanding of, TVHC’s Service Excellence Standards, by modeling service excellence in all internal and external relationships, addressing service excellence deficits in staff, and in performance of all duties and responsibilities of this position.
In the absence of CMO, or when directed by the CEO or Designee: may be asked to assume responsibilities and authorities of Chief Medical Officer, on an interim basis as required to ensure regulatory compliance and the ongoing clinic operations of TVHC.
Collaborates with Management Team members, as directed, to develop strategies and policies and provides consultation within scope of responsibility.
Performs other related duties as may be assigned by Chief Medical Officer and or Chief Executive Officer.
Requirements
Must have license as an NP, CNM or PA, and board certification or eligibility within discipline required.
Current, valid license to practice medicine in the State of California, including DEA license (if applicable) and CPR required.
Minimum three (3) years of clinical experience required.
Minimum two (2) years of experience supervising providers and other clinical staff preferred.
Experience in underserved communities or in a community health center setting preferred.
Qualifications:
Proficiency in clinical practice within the specified medical specialty.
For MDs or DOs, a willingness to collaborate with and provide supervision to NP/PA/CNM providers as required.
Ability to travel to designated locations as required by supervisor.
Demonstrated ability to work effectively independently and as part of a team, in collaborative settings, required.
Excellent written and verbal communication skills required.
Understands and is committed to maintaining highest level of confidentiality.
Demonstrated ability to provide leadership to staff and build the trust and respect of patients, staff, colleagues, and external contacts.
Commitment to remaining up-to-date with evidence-based, best practices in internal medicine and community-based medicine
Willingness and ability to work some evenings and weekends, as needed.
Ability to utilize computer technology preferred, and willingness to develop and adapt to the evolving technological requirements of modern medical health center practices required.
Demonstrates flexibility regarding job duties and assignments.
Benefits
Health & Wellness
Medical: 100% employer-paid co-payments, prescriptions, and premiums
Dental & Vision Coverage: employer-paid premiums
Life Insurance
Pet Insurance
Short-Term and Long-Term Disability
Chiropractic/Acupuncture: 100% employer-paid
Employee Assistance Program (EAP)
Financial Benefits
Retirement Plan with Matching!
Guaranteed Salary Increases
Flexible Spending Accounts: Healthcare & Dependent Care
NHSC/HRSA Loan Repayment Eligibility
Visa Assistance
Commuter Benefits
Scrub Allowance
Paid Time Off & Leave
Generous Paid Time Off for Vacation & Sick
13 Paid Holidays
Educational Leave
Travel Assistance Program
Professional Development & Career Growth
Tuition Reimbursement
Continuing Education Reimbursement
Scholarship Program
Professional Membership Reimbursement
Career Growth Opportunities
EPIC Superusers
Recognition Programs
Work Environment & Perks
Dragon Ambient Experience (DAX) AI Clinical Documentation
Malpractice Insurance Covered
Monthly Treats
Bilingual Medical Assistants
Employee Discounts
Employee Referral Program

Hayward, CA, USA
$69.39-82.86
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