Vice President/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 development organization. Reporting to the CMO, the VP/Sr. Director, Clinical Development will provide medical leadership and oversight of Centessa’s clinical programs. The role requires leadership and hands on contributions both at a strategic level and hands-on project level work. The VP will have prior experience in the biotech/pharma industry, in rare disease therapeutic areas and across the development cycle of an asset (early to late phase).
- Lead the strategy and execution of development programs across the Centessa portfolio as the head and key point of accountability for the clinical development and clinical science.
- Communicate medical and clinical research concepts and create, assemble evidence, and win internal consensus on program and portfolio strategies that will set up clinical programs and trials for success.
- Willingness to work at the program or clinical trial level as well as guiding/overseeing the CRO and consultant medical and clinical science resources.
- Liaise with Clinical Operations, CRO and other cross functional areas to ensure the progression of clinical studies within the expected time frame.
- Play a key role in regulatory and health authority interactions.
- Lead clinical development contributor to regulatory activities, submissions, and clinical sections of regulatory/health authority pre-meeting packages and initial applications, routine annual reports, ad hoc safety reports (SUSARs), interim and final CSRs, etc.
- Author asset and clinical trial level plans, charters, documents.
- Minimum of 15 years of overall experience (academia, clinical practice, pharma/biotech industry, etc.)
- 8-10 years of pharmaceutical/biotech industry experience, including managing clinical development and clinical science teams, clinical development programs and clinical trials is requirred
- MD or MD/PhD (includes internationally recognized equivalent) is mandatory
- Rare disease therapeutic area experience is preferred
- Willingness to deliver project and tactical level work whilst building structure and function
- Excellent working knowledge of regulations across various agencies (FDA, EMA, etc.) and GCP, & ICH guidelines. Knowledge or experience supporting regulatory or health authority inspections a plus.
- Experience leading and authoring clinical development inputs into regulatory submissions (IND, CTAs, NDA/BLAs, designation applications, etc.) and representing clinical development in agency interactions.
- Experience authoring and guiding teams with key asset and clinical trial level plans and documents.
- Advanced knowledge in clinical development strategy, clinical trial design, regulatory pathways, biostatistics methodologies, and ability to analyze and interpret translational medicine, clinical, and research data as it relates to an asset, patients, etc.
- Possess excellent written and oral communication skills with internal and external stakeholders
- Proven ability to work collaboratively, take initiative, solve complex issues, and deliver results in a fast-paced, team-based matrix environment
- Demonstrate sound judgement in handling complex, confidential, and highly regulated information
- Ability and willingness to travel as required.
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.
NO THIRD PARTY RESUMES WILL BE ACCEPTED AT THIS TIME.