Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company
Executive Director, Clinical Development
Boston, MA · Director · Full-time
Sponsorship not specified$340k-$380kDetected 6 days ago
GCPClinical TrialsFDA RegulatoryResearchExperimental DesignAnimal StudiesLeadershipCommunicationPublic SpeakingBiostatistics
About the role
- The Executive Director, Clinical Development will play a critical leadership role in advancing our clinical programs in sleep-wake disorders and broader CNS indications.
- Given the broad pipeline within the organization, the Executive Director must bring deep experience spanning preclinical through late-stage clinical development, with the ability to shift fluidly across programs as priorities change.
- Success requires a collaborative, agile mindset; exceptional communication skills; and the ability to influence across a matrixed organization.
Responsibilities
- 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.
- 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.
- Lead asset level clinical sub-teams and play key leadership role on program team for clinical development.
- Liaise with cross functional partners, vendors, and CROs to ensure the progression of clinical studies within the expected time frame.
Requirements
- Minimum 8 years of combined experience across academia, clinical practice, pharma/biotech industry, etc.
- Minimum 5 years of pharmaceutical/biotech industry experience, including managing clinical development programs and clinical trials
- Experience leading and authoring clinical development inputs into regulatory submissions (IND, CTAs, NDA/BLAs, designation applications, etc.) and representing clinical development in agency interactions.
- Ability and willingness to travel as 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 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
Nice to have
- MD required, MD/PhD strongly preferred (includes internationally recognized equivalent)
- Substantial experience supporting CNS / neuroscience drug development required
- sleep medicine and associated therapeutic areas strongly preferred
- Excellent working knowledge of regulations across various agencies (FDA, EMA, etc.) and GCP, & ICH guidelines.
Compensation
- 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.
Benefits
- 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.
- Play a key role in regulatory and health authority interactions.
- 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.).
Company info
- Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company 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.
- We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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