Vice President, Clinical Development

Location:                     Boston, MA, or London, UK Reporting to:               Chief Medical Officer   Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the life of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cell (HSC). Orchard has its global headquarters in London and U.S. headquarters in Boston.   Reporting to the Chief Medical Officer, the VP of Clinical Development will oversee the activities of the Clinical Science organization.  This person will be key in driving the strategy for clinical development, the clinical development plans, managing the clinical studies, drive the regulatory documentations/presentations, writing and executing regulatory interactions together with the regulatory teams. This person will have oversight of Clinical Science across the Orchard portfolio and will serve as a key member of the Medical/Clinical Development (MCD) leadership team. Responsibilities   ·         Lead the Clinical Science team on execution of departmental objectives, and provide guidance on design of clinical development strategies and protocols that meet strategic, scientific and regulatory objectives of Orchard’s clinical assets ·         Cultivate a high-performing, collaborative culture through leadership of the Clinical Science leads to advance professional development for individual assets/franchises. Development department annual operating plan (AOP) and ensure adherence to annual budget targets, including effective oversight of third party vendors ·         Monitors departmental progress on program objectives and develops contingency plans as needed ·         Manage departmental activities pertaining to clinical development plans, study endpoint selection including laboratory endpoints, study execution, medical monitoring, safety monitoring, study report development/medical writing, etc. ·         Accountable for ensuring departmental adherence to GxP, particularly GCP, as well as all relevant Orchard policies and SOPs ·         Ensure effective cross-functional collaboration with Clinical Operations, Data Management, Biostatistics, Regulatory, Medical Affairs, Pharmacovigilance and other teams supporting clinical development ·         Actively contribute to the preparation of regulatory documents related to the area of work.  Represents Orchard Clinical Development in meetings with regulators (FDA, EMA, MHRA, etc.). ·         Assess signal detection, early safety signals with the PV team and represent Clinical Development on Safety Governance teams ·         Participates in planning/driving medical affairs activities together with the medical team. May represent the organization in congresses, patient advocacy groups, etc ·         Serve as clinical subject matter expert across the organisation. ·         Participates in business development initiatives for new programs ·         Able to work and navigate the complexities of academic/biotech interface, working as part of a global organisation, building and maintaining relationships with external stakeholders, and integrated working with academic partners. ·         Up to 20% travel required Requirements Experience   ·         At least 10 years experience in clinical development ·         Highly desirable experience – ultra rare disease, gene therapy, paediatrics, neurometabolic disease, IBD ·         Demonstrated experience in leading a matrix team, vendors and clinical development activities ·         Managerial experience ·         In depth understanding of regulatory environment, GCP/ICH, experience interacting with regulatory agencies ·         Proven track record of designing, leading, and executing clinical trials (Phases I–III). ·         Highly desirable experience – leadership of a regulatory file process (eg BLA, EU MAA, IND, CTA) ·         Experience working with complex programmes, ideally experience in Gene/Cell Therapy programs ·         Demonstrated ability to develop and execute clinical development strategies that align with broader corporate goals ·         Desired experience – pharmacovigilance reporting, management, and operations ·         Desired experience – US regulatory environment, US government affairs   Skills   ·         Proven leadership and decision-making skills – A mature professional capable of independently leading teams and making sound recommendations to senior management or board-level stakeholders. ·         Highly accountable and dependable – Takes ownership of responsibilities and consistently delivers results. ·         Collaborative and team-oriented – Works effectively across functions, building strong relationships, seeking critical insights, and constructively challenging assumptions to drive resource optimization. ·         Strong record of building and mentoring high-performing clinical teams. ·         Strategic thinker – Brings a forward-looking mindset to problem-solving, aligning actions with long-term goals. ·         Exceptional organizational skills – Able to manage multiple priorities and projects simultaneously, adapting to changing business needs. ·         Excellent presentation and communication skills – Proficient in delivering information and understanding through email and verbal forums, including using tools such as Excel and PowerPoint. ·         Flexible and solutions-driven – Brings a positive, “can-do” attitude and readily adapts to changing circumstances. ·         Experienced in remote collaboration – Able to work effectively within a virtual or distributed organization. ·         Experience overseeing global, multi-center trials, understanding regional regulatory and operational differences. ·         Strong data management capabilities – Skilled in handling and interpreting complex datasets to inform decisions. Experience with data monitoring committees and adjudication boards. ·         Thrives in dynamic ‘biotech’ environment – Performs effectively in high-stakes or fast-paced environments. ·         Influential collaborator – Able to engage and partner with world-leading experts to drive initiatives forward. Education   ·         Medical Degree (MD/MBBS) ·         Ideally background in gene therapy, immunology, and or haematology/oncology