Vice President, Clinical Sciences
Vice President, Clinical Sciences
Location: Boston, MA USA
Reporting to: Chief Medical Officer
Reporting to the Chief Medical Officer and serving on the Clinical Development Leadership Team, the Vice President/Senior Vice President of Clinical Sciences is an effective team leader and experienced clinical development physician who will direct clinical development activities for Orchard’s hematopoietic stem cell gene therapy (HSC-GT) programs in neurometabolic diseases and immunological disorders. This individual oversees a team of clinical scientists and clinical development physicians who lead the design and conduct of Orchard’s Phase I-IV clinical trials and represent Clinical Development on cross-functional program strategy teams. A key member of the R&D Leadership team, this individual will foster strong collaboration between their Clinical Sciences organization and colleagues in Clinical Operations, Pharmacovigilance, Biostatistics, and Medical Affairs.
Key Elements and Responsibilities
- Leads clinical development strategy and execution of clinical trials including natural history studies, proof-of-concept trials, registrational trials, and post-marketing studies across the Orchard portfolio
- Manage team of clinical scientists and clinical development physicians in the execution of department deliverables. The clinical development physicians may also act as medical monitors.
- Ensure effective representation of Clinical Development on cross-functional program strategy teams and contribution to key program deliverables
- Partners with CMO to lead the Protocol Review Committee that achieves cross-functional alignment and approval of clinical study concepts and protocols
- Oversees department collaboration with Regulatory Affairs on development of INDs, CTAs, BLAs, MAAs and other regulatory submissions globally. Represents Clinical Development in interactions with FDA, EMA and other regulatory bodies.
- Partners with Clinical Operations to ensure timely execution of clinical development activities
- Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
- Collaborates with Medical Communications on the development of strategic publications supporting clinical development activities
- Participates in the selection of clinical trial sites and investigators, and provides ongoing guidance to investigators during conduct of studies
- Provides medical guidance to internal collaborators including Clinical Operations and Biostatistics, and to external collaborators including contract research organizations (CROs).
- Serves as an external clinical subject matter expert and represents Orchard at external scientific and industry meetings
- Provides or oversees provision of Clinical Sciences input on review of investigator-initiated study requests, compassionate use requests, and other external activities as needed
- Oversee clinical sciences department annual planning and budget development in partnership with Finance
- Ensures that Clinical Science is fully resourced for the agreed objectives
- Develop medical and scientific talent within the Clinical organization, fostering professional development in line with Orchard’s key values and core behaviors
- Manages an international team and requires approximately 25% international travel
- Oversee study design, protocol development, medical monitoring, and development of clinical documents including investigator brochures, study reports and integrated analyses
Qualifications and Education
- Medical degree (MD or equivalent) is required. US Board Certification strongly preferred.
- At least 10 years of experience in clinical development, with at least 5 years experience in managerial positions
- Experience in gene therapy and/or rare disease strongly preferred
- Experience in the full range of clinical development (Phase I-IV)
- Demonstrated experience with complex clinical trial design
- Experience in international clinical trials
- Direct experience interacting with FDA required; experience interacting with EMA strongly preferred.
- Robust understanding of all aspects of clinical development
- Must be fluent in English
Skills and Abilities
- Mature individual, capable to work independently and make decisions/ recommendations to a board/ management team
- Accountable and responsible individual
- Collaborative working style; the ideal candidate will partner effectively with their colleagues across the organization to share critical information, constructively challenge plans
- Strategic mindset
- Excellent organisational skills; the ideal candidate will be able to prioritize activities depending on business imperative and to contribute to several projects in parallel
- Outstanding presentation skills (Excel, Powerpoint)
- ‘Can-do’ attitude and willingness to be flexible
- Able to work in a virtual enterprise
- Able to manage complex data
- Able to work in a pressurized environment
- Able to manage/collaborate with a group of world leader experts
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
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