United States onlyThe Company:With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role
The Senior Director, DMPK will serve as the company’s key expert overseeing DMPK strategy across the entire company, including late-stage discovery, development, NDA submission, and commercial readiness, as well as designing, implementing, and interpreting DMPK studies, ensuring high-quality data and regulatory-ready documentation to support IND, CTA, and NDA filings.
As part of a growing biotech organization, the role requires a hands-on, collaborative leader who can build and guide a high-performing team while working cross-functionally to advance a dynamic portfolio.
This is a pivotal leadership role in a fast‑growing biotech preparing for its first commercial launch.
Responsibilities
- Provide scientific leadership for all DMPK activities across discovery, preclinical, and development-stage programs.
- Develop and execute DMPK strategies, including ADME, bioanalysis, PK/PD modeling, and in vitro/in vivo metabolism studies.
- Serve as the primary DMPK representative on program teams, influencing strategy, timelines, and go/no-go decision‑making.
- Evaluate DMPK liabilities and optimization strategies for new chemical entities.
- Serve as the DMPK lead on cross‑functional program teams (preclinical, clinical, regulatory, CMC, translational medicine).
Study Design & Execution
- Oversee design, outsourcing, and interpretation of ADME, PK, TK, and metabolism studies conducted under GLP and non-GLP conditions.
- Lead bioanalytical method development and validation to support preclinical and clinical studies.
- Ensure integration of PK/PD modeling and simulation to inform dose selection and clinical study design.
- Build and manage relationships with CROs and external partners, ensuring quality, compliance, and scientific rigor.
Regulatory and Documentation
- Author and review DMPK sections of regulatory submissions (IND/CTA, IB, briefing packages, NDAs/MAAs).
- Represent the company in regulatory agency interactions (FDA, EMA, etc.) as the DMPK subject matter expert.
- Ensure compliance with all relevant regulatory guidelines, including GLP and ICH.
- Lead DMPK strategy for Nuvalent’s pipeline ensuring data quality that supports INDs, NDAs, and global regulatory interactions.
Competencies
- Demonstrated ability to collaborate across matrixed, cross-functional teams in a fast-paced environment.
- Proven ability to manage multiple projects simultaneously with attention to timelines and detail.
- Strong communication and interpersonal skills; build trust and foster relationships internally and externally.
- Able to work independently, take initiative, and adapt quickly to evolving priorities.
- Recognized leader who exhibits effective communication, emotional intelligence, and influencing skills, within a matrix operating environment.
- Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
- Ability to effectively manage multiple projects with competing priorities.
Qualifications
- 12+ years of industry experience in DMPK, including leadership responsibility.
- D. in Pharmaceutical Sciences, Pharmacokinetics, Biochemistry, Chemistry, or related discipline; postdoctoral training preferred.
- Proven track record supporting programs from discovery through clinical development; experience with IND and NDA/MAA submissions strongly preferred.
- Demonstrated experience supporting small‑molecule oncology therapeutics, ideally kinase inhibitors or targeted therapies.
- Hands‑on expertise with ADME assays and mechanistic metabolism studies and PK/PD modeling and simulation, proficient in Phoenix WinNonlin, preferred: experience with GastroPlus modeling.
- Experience contributing to late‑stage development and NDA filings, preferably in oncology.
- Prior experience supporting products approaching commercial launch.
- Experience with vendor/CRO oversight and budget management.
- Experience working in a small/mid-size biotech environment preferred (rapid decision-making, cross-functional collaboration, matrix leadership).
Additional Information
Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.
The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.
Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
