Sr. Director, Clinical Pharmacologist

COMPANY:

Centessa Pharmaceuticals plc (Nasdaq: CNTA) 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.

SUMMARY:

The Sr. Director, Clinical Pharmacologist will be responsible for driving translational pharmacokinetic and pharmacodynamic aspects of drug development to support the research and clinical development of orexin agonist(s) programs in various sleep disorders. This role will lead clinical pharmacology activities for multiple programs and will provide technical expertise for regulatory interactions and submissions. While the role is focused on the Orexin programs, there may be times this role contributes to other Centessa programs. This individual will need to demonstrate strong hands-on leadership, communication, and relationship building skills to drive results in a matrixed environment.

RESPONSIBILITIES:

• Lead clinical pharmacology activities for the assigned projects and accountable for the planning ad exaction of clinical pharmacology strategies.
• Plan and direct clinical pharmacology studies in collaboration with internal and external partners, including collaboration with KOLs in neurology and sleep research.
• Use PK/PD modeling and translational clinical outcome measures to support dose selection, efficacy, and safety assessment of drug candidates.
• Oversee clinical pharmacology vendors and ensure accurate and efficient PK data collection.
• Apply pharmacokinetic and pharmacodynamic modeling and simulation techniques to optimize study design, data analysis, and interpretation.
• Advise and draft the relevant sections of the clinical study protocols, reports, and regulatory documents in compliance with relevant guidelines and standards.
• Communicate and present clinical pharmacology findings and recommendations to internal and external stakeholders.
• Interface cross-sectionally across all disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC.
• Maintain flexibility in working through virtual and in-person interactions to coordinate with global team members and vendors.
• Author scientific publications and present at scientific conferences.
• Provide effective vendor overnights to ensure high quality data delivery

QUALIFICATIONS & EXPERIENCE:

• PhD or equivalent in pharmacokinetics (PK)/pharmacodynamics (PD), pharmacology, pharmaceutical sciences, or a closely related discipline.
• Minimum 5 years of pharmaceutical industry experience in clinical pharmacology overseeing development of small drug molecules (focus) and large molecules.
• Strong experience of scientific and operational leadership of clinical pharmacology strategies/studies to support clinical development and regulatory submissions (CNS preferred). Deep understanding and experience in the utility of how model-informed drug development in CNS drug development is a plus.
• Experience in authoring clinical study protocols, reports and regulatory documents such as INDs; experience in NDAs is also preferred.
• Hands on experience conducting standard non-compartmental and compartmental PK analysis, PK/PD analyses for drug development projects to support decision making, dose selection and dosing regimen optimization and regulatory interactions. Advanced proficiency in using clinical pharmacology software tools including, but not limited to NONMEM, r, Phoenix, NMLE, and/or SAS preferred.
• Knowledge of study protocols, clinical endpoints and PK/PD modeling for sleep disorders is highly desirable.
• Working knowledge of US and EU regulatory requirements and guidelines.
• Be able to work in a matrix team environment and influence the team with a data-driven approach.
• Good interpersonal and communication skills with the ability to articulate complex ideas/findings to internal stakeholders to ensure clarity and understanding.

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.