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

Experience

Skills

Education

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