(Sr.) Director, Clinical Development
The mission of Centessa Pharmaceuticals plc (Nasdaq: CNTA) is to deliver consequential new medicines to patients. The Centessa family includes ten wholly owned, highly specialized companies, with drug discovery and development programs in diverse therapeutic areas. The company’s organizational structure and approach combine the agility and sense of urgency typical of start-up companies with the scale and diversification typical of larger R&D organizations.
Centessa is growing its clinical organization and we are looking for a (Sr.) Director, Clinical Development. We are looking for a highly capable physician with early phase to late phase clinical development. The (Sr.) Director, Clinical Development will serve as the primary medical lead accountable for the benefit and risk of an investigation product and responsible for the safe and ethical conduct of clinical investigations for assigned clinical stage programs and trials.
- Provides key medical and scientific input (where applicable, approval) and participates in the development of the following for assigned programs and clinical trials:
- Content for documents supporting regulatory/health authority engagement, submissions such as clinical section of IND’s and CTA’s, IND safety reports and annual reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Core documents and deliverables such as protocols/amendments, IBs, TPPs, clinical strategy/design, CDPs, SAP, CRF, translational/biomarker plans, ICFs, patient facing materials, CSRs, and any relevant key clinical trial plans, documents, and templates.
- Clinical trial medical, safety, laboratory data including all relevant trial outputs such as line listing reviews (TLFs), patient profiles, clinical content (to support publications, etc.), protocol deviations, etc.
- All documents and plans related to DSMB, safety review committees, dose escalation committees, medical monitoring, and safety/pharmacovigilance.
- Translational/biomarker plans and strategies.
- When applicable, works closely with the AD/Director, Clinical Science to deliver all medical, scientific, and clinical aspects of programs and trials.
- Maintain a high level of clinical and scientific expertise in relevant disease area(s) by reviewing the literature, attending medical/scientific meetings.
- Develop & maintain strong relationships with internal and external stakeholders (e.g., KOLs, patient advocacy groups, principal investigators, and other external scientific and medical expert consultants) to apply relevant insights to assigned clinical programs and trials.
- Present at scientific, medical, and regulatory meetings globally as well as author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
- Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards.
- As delegated by the CMO, may provide clinical development contributions to due diligence or other business development activity.
- MD or equivalent ex-US medical degree.
- 5-10 years clinical trial experience in an academic or industry setting, with working knowledge in the analysis of research data and publications, biostatistics, translational medicine (biomarkers, pharmacokinetics, etc.), scientific/clinical research methods, clinical study design, and regulatory requirements for clinical studies.
- 1-2 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) mandatory
- At least 1 year as an attending physician in oncology/hematology, or rare disease space preferred
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
POSITION: Full-Time, Exempt, Flexibility for Remote Work
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.