Executive Director, Clinical Development

Executive Director, Clinical Development

The Executive Director, Clinical Development will play a critical leadership role in advancing Centessa's clinical programs in sleep-wake disorders and broader CNS indications. Reporting directly to the Senior Vice President, Clinical Development, this leader will assume primary responsibility for the strategic and operational execution of the company's late-stage Orexin Receptor 2 Agonist Program (Program 750), which targets narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.

Given the broad pipeline within the organization, the Senior Director must bring deep experience spanning preclinical through late-stage clinical development, with the ability to shift fluidly across programs as priorities change.

In this highly visible, hands-on role, the Executive Director will collaborate closely with cross-functional partners across Clinical Operations, Regulatory Affairs, Translational Medicine, Biometrics, Safety, and external stakeholders. The individual will provide scientific and medical leadership for clinical study design, execution, data interpretation, and regulatory interactions. This role requires a collaborative and agile mindset, exceptional communication skills, and the ability to influence across a matrixed organization.

This position is ideal for those seeking:

• The opportunity to lead a late-stage asset with the potential to transform standard of care for individuals living with sleep-wake disorders
• A role within a lean, fast-paced, growth-oriented biotech environment requiring deep CNS expertise
• A collaborative, science-driven, and patient-focused culture
• A remote working environment with high visibility and strategic impact

Key Responsibilities

• Serve as a senior clinical leader for Program 750, providing medical and scientific leadership for late-stage development while maintaining readiness to support earlier-stage or emerging programs.
• Author and oversee clinical study protocols for orexin receptor agonists, ensuring scientific rigor, operational feasibility, and alignment with regulatory expectations.
• Contribute to and help develop integrated clinical development plans spanning preclinical translation through late-stage trials, enabling efficient advancement of multiple candidate molecules.
• Collaborate closely with Clinical Operations to meet quality, timeline, and budget expectations across all studies within the 750 program and other CNS programs as needed.
• Provide real-time medical and scientific guidance for ongoing clinical trials, including data review, safety oversight, and acceleration of development programs.
• Partner with Translational Medicine to support biomarker strategy, dose selection, and evaluation of indication of expansion opportunities.
• Engage effectively with investigators, KOLs, and external experts to ensure Centessa's orexin agonist programs remain at the forefront of scientific and clinical innovation.
• Communicate clinical and scientific updates across internal teams and external stakeholders.
• Contribute to the preparation, authorship, and review of clinical sections of regulatory submissions, including INDs, protocol amendments, briefing documents, annual reports, safety reports, and clinical study reports.
• Ensure robust oversight of safety monitoring and adherence to Good Clinical Practice (GCP), pharmacovigilance standards, internal SOPs, and quality requirements.
• Support regulatory interactions with global health authorities, including preparation for key meetings, responses, and ongoing communication.
• Provide senior oversight of study integrity, safety, efficacy data, and risk-benefit assessments across assigned programs.
• Ensure that clinical insights and external evidence are synthesized and used to guide strategic decision-making across the portfolio.

Qualifications

• MD in neurology/neuroscience required; board certification required (includes internationally recognized equivalent); MD/PhD strongly preferred
• Minimum 10 years of combined professional experience in CNS therapeutic areas academia, clinical practice, and/or the pharmaceutical or biotech industry
• Minimum 5 years of pharma or biotech industry experience with demonstrated leadership of: Clinical development programs, global clinical trials and clinical science organizations
• Deep expertise in CNS therapeutic areas, with direct experience in sleep disorders
• Proven people and line management experience within a pharma/biotech environment
• 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 position is $290,000 to $375,000. 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 and participation in our equity program, allowing you to share in Centessa's long-term success.

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.

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

EEOC Statement: 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.

Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.