Cogent Biosciences · 3 weeks ago
Director, Clinical Pharmacology
Waltham, MA
Full-time
Onsite
Director/Executive
$225K/yr - $260K/yr
8+ years expCogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. They are seeking a highly motivated Director of Clinical Pharmacology to lead model-informed drug development strategies across oncology and rare hematological disease programs, combining strategic vision with hands-on expertise in pharmacokinetics and modeling.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
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
Benefits
Competitive pay
Performance-based bonus
Stock options
Insurance coverage (health, dental, life, and disability)
Competitive time-off
A 401(k) plan
Commuter/parking benefits
Company
Cogent Biosciences
Cogent Biosciences is a biotechnology company that develops therapies for solid cancer tumors.
51-200 employees
H1B Sponsorship
Cogent Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.6BKey Investors
Commodore CapitalFairmount Funds ManagementSquare 1 Bank
2025-11-10Post Ipo Equity· $200M
2025-11-10Post Ipo Debt· $200M
2025-07-08Post Ipo Equity· $230M
Leadership Team
Andrew Robbins
CEO and President
A
Abb Hayden
Senior Vice President of Sales
Recent News
2025-12-31
Company data provided by crunchbase