Description of Role

Key Responsibilities

Strategic Leadership & Oversight 

• Develop and execute a comprehensive pharmacovigilance (PV) strategy aligned with corporate objectives and regulatory expectations.
• Lead safety governance and benefit-risk management for small molecule assets across development and post-marketing.
• Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.).
• Provide strategic safety input into clinical trial designs, protocols, and regulatory submissions.
• Establish and oversee PV partnerships, vendors, and external collaborations. 

Operational & Regulatory Compliance 

• Lead the safety surveillance and signal detection process, ensuring timely identification and mitigation of safety risks.
• Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts).
• Ensure robust case processing, signal evaluation, and risk management processes are in place.
• Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.). 

Cross-Functional Collaboration 

• Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making. 
• Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
• Support DSMBs, advisory boards, and investigator meetings with safety expertise. 

Team Leadership & Development 

• Build and lead a high-performing pharmacovigilance team, fostering a culture of scientific excellence and compliance.
• Provide mentorship and guidance to internal safety professionals. 

Compensation

The annual base salary range for this position is $350,000.00 to $380,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Vice President, Pharmacovigilance and Safety role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

Description of Role

We are seeking a Senior Scientist, Drug Safety (Pharmacovigilance) to support pharmacovigilance activities across Centessa’s clinical-stage development programs. Reporting to Centessa’s Head of Safety and Pharmacovigilance, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance, regulatory compliance, and program execution. The Senior Scientist will work closely with cross-functional partners and external vendors to ensure high-quality safety deliverables and maintain inspection-ready pharmacovigilance processes in a fast-paced, development-focused environment. 

Key Responsibilities

• Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs. 
• Lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions, including SUSARs, in alignment with global reporting requirements. 
• Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products. 
• Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings to cross-functional stakeholders. 
• Ensure the scientific integrity and quality of safety data through expert review of complex cases and mentorship of junior team members in case assessment and safety data interpretation.  
• Provide senior level scientific input into the preparation and review of DSURs, line listings, safety summaries, and safety-related sections of protocols, Investigator’s Brochures, and regulatory submissions. 
• Serve as the lead drug safety representative on cross-functional study teams, shaping safety strategy, influencing program decision-making, and advising on safety issue management.
• Maintain expert level knowledge of therapeutic areas and global drug safety regulations, guidelines, and evolving best practices (e.g., FDA, EMA, ICH, CIOMS), and apply this expertise to program decisions and safety governance. 
• Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.  
• Lead or contribute to complex, cross-functional safety projects, safety signal evaluations, and ad-hoc scientific analyses to support portfolio needs and organizational priorities. 

Qualifications

•  PharmD or PhD in scientific field
• 6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.  
• Prior experience facilitating in Safety Risk Assessment Meetings / Safety Review activities required. 
• Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP).
• Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred.
• Experience supporting clinical safety case processing and aggregate reporting.
• Strong analytical skills, attention to detail, and comfort working across multiple programs.
• Clear communicator who works effectively in small, cross-functional teams.
• CNS experience preferred. 

Compensation 

The annual base salary range for this job level is $145,000 to $190,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location 

Based in the US, with <10% travel.

POSITION: Full-Time, Exempt

Description of Role

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).  

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. 

QUALIFICATIONS:

• 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.

The annual base salary range for this level is $300,000.00 to $375,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Executive Director, Clinical Development role is a remote role based in the US, with occasional travel.