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, Clinical Pharmacology will lead Nuvalent’s clinical pharmacology strategy across all development programs, including late‑stage registrational efforts and emerging early‑phase assets. This leader will guide dose optimization, exposure–response modeling, regulatory strategy, and clinical pharmacology components of NDA submissions.
Responsibilities:
- Serve as the clinical pharmacology lead and develop and execute strategies to support Phase 1, registrational, and post‑marketing studies, including designing and leading clinical pharmacology studies.
- Drive the integration of PK, PD, safety, and efficacy data to inform dose selection, dose modification, and labeling recommendations.
- Lead clinical pharmacology contributions to INDs, CTAs, IBs, and NDA submissions.
- Represent clinical pharmacology in interactions with FDA and other global regulators, supporting discussions related to dose justification, pediatric waivers, safety margins, and DDI strategies.
- Partner closely with DMPK, Non-clinical Toxicology, Clinical Development, Biostatistics, CMC, and Regulatory Affairs to ensure cohesive end‑to‑end development plans.
- Oversee population PK modeling, PK/PD modeling, and exposure–response analyses for efficacy and safety.
- Guide quantitative pharmacology approaches supporting optimal dosing in patients.
- Build and mentor a growing clinical pharmacology function as Nuvalent transitions from clinical‑stage to commercial‑
- Contribute to portfolio prioritization, scenario planning, and long‑range clinical development strategy.
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:
- D., Pharm.D., or M.D. with specialization in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
- 12+ years of experience in clinical pharmacology within biopharma, including leadership in oncology or small‑molecule drug development.
- Proven track record supporting registrational‑stage programs and authoring components of regulatory submissions (INDs, NDAs/MAAs).
- Prior work with kinase inhibitors, and oncology therapies strongly preferred.
- Familiarity with late‑phase trial design and commercial launch preparation.
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.
