Executive Director, Clinical Development

Centessa Pharmaceuticals, LLC•Boston, MA

3d•Remote

About The Position

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data-driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Centessa is growing its clinical development organization. Reporting to the SVP, Clinical Development, the Executive will provide medical leadership and oversight to Centessa’s programs and associated clinical trials. The role requires leadership and contributions both at a strategic level and hands-on project level work. Executive Director will have prior experience in the biotech/pharma industry, in neurodegenerative/neuropsychiatric therapeutic areas and across the development cycle of an asset (early to late phase).

Requirements

MD required, MD/PhD strongly preferred (includes internationally recognized equivalent)
Minimum 10 years of overall experience (academia, clinical practice, pharma/biotech industry, etc.)
Minimum 5 years of pharmaceutical/biotech industry experience, including managing clinical development and clinical science teams, clinical development programs and clinical trials
Prior pharma/biotech and line management experience – Required
CNS therapeutic area (particularly neurodegenerative/neuropsychiatric) experience- Required
Willingness to deliver project and tactical level work
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.
Strong 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.

Nice To Haves

Knowledge or experience supporting regulatory or health authority inspections a plus.

Responsibilities

Primary point of contact for clinical development activities with willingness to work strategically and hands on at the program and clinical trial levels.
Accountable for the oversight, monitoring and surveillance of overall risk, safety, benefit/efficacy to patients as well as compliant trial execution and optimal integrity of data.
Responsible for establishing relationships and communication with KOLs, investigators and relevant site medical (or other supportive roles) personnel.
Lead the clinical development strategy and innovative approaches for the overall clinical pathway for the asset.
Key clinical development contributor to publication strategy and planning, authoring of publications, posters, etc., and present or support presentations, posters, etc., in conferences and meetings.
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.
Determine optimal clinical trial design options that are innovative, patient centric, cost efficient, and enable meeting business goals.
Responsible for review, analysis and interpretation of all clinical trial data including assessment of protocol deviations.
Lead asset level clinical sub-teams and play key leadership role on program team for clinical development.
Lead asset level and trial level medical forums as needed (safety review committee, ad board, KOL meetings, medical review/discussions of patient cases, cohort review meetings, etc.).
Attend and present as needed at core team meetings, investigator meetings, site visits, etc.
Liaise with cross functional partners, vendors, and CROs to ensure the progression of clinical studies within the expected time frame.
Provide clinical evaluation and interpretation of pre-clinical results.
Remain current on the development of orexin agonists and the relevant therapeutic areas through review of the scientific literature, interactions with KOLs and other external experts and attendance at relevant scientific meetings, to provide input and guidance for the strategic direction of Centessa clinical stage programs.