Director, Clinical Pharmacology - Waltham - Cogent Biosciences

    Cogent Biosciences
    Cogent Biosciences Waltham

    8 hours ago

    Description
    Who We Are:

    Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patient's.

    The company's lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and GIST. In July 2025, Cogent announced that its registration-direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025. The company also remains on track to announce top-line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.

    Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights.

    The Role:

    We are seeking a highly motivated Director of Quantitative Clinical Pharmacology to join our dynamic team. This leadership role will drive model-informed drug development strategies across oncology and rare hematological disease programs. The ideal candidate will combine strategic vision with hands-on expertise in population pharmacokinetics (PopPK), PK/PD modeling, and quantitative approaches to optimize dose selection and accelerate development timelines.

    Responsibilities:
    • Serve as the Clinical Pharmacology representative on cross-functional clinical development teams, providing scientific and strategic input from early development through registration and post-marketing.
    • Design and implement model-based drug development strategies, including PopPK and PK/PD modeling, exposure-response analyses, and simulations to inform dose selection and trial design.
    • Responsible for design and execution of clinical pharmacology strategy including design of clinical pharmacology studies and/or use of alternative modeling approaches.
    • Author and review clinical pharmacology sections of regulatory documents (INDs, NDAs, briefing books) and lead responses to regulatory agency queries.
    • Collaborate closely with Clinical, Biostatistics, Regulatory, and Research teams to ensure integrated development plans.
    • Mentor junior scientists and foster a culture of innovation in quantitative pharmacology.
    • Stay current with regulatory guidance and emerging methodologies in pharmacometrics and clinical pharmacology.
    Qualifications:
    • PhD, PharmD, or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or related quantitative discipline.
    • 8+ years of industry experience in clinical pharmacology and pharmacometrics, with a proven track record in oncology and/or rare diseases.
    • Demonstrated hands-on expertise in PopPK and PK/PD modeling using tools such as NONMEM, Monolix, R, and/or similar platforms.
    • Strong understanding of model-informed drug development (MIDD) principles and regulatory expectations.
    • Excellent communication skills with the ability to influence and lead in a fast-paced, collaborative environment.
    • Experience interacting with global health authorities and contributing to successful regulatory submissions.
    Salary Range:

    $225-$260K USD

    Target Bonus: 20%

    Exact compensation will vary based on skills, experience, and location.

    Our Locations

    Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.

    Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent's discovery research organization.

    Our Offer To You

    To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.

    We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.

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