Senior Director, Drug Metabolism and Pharmacokinetics

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🕒 Março 24

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $270.000 - $295.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Nuvalent, Inc.

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11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

A Nuvalent, Inc. é uma empresa de biotecnologia focada no desenvolvimento de terapias direcionadas para pacientes com câncer. Com uma base sólida em química e descoberta de medicamentos baseada em estrutura, a Nuvalent projeta moléculas pequenas inovadoras para inibir efetivamente alvos de quinase, superando desafios de resistência e seletividade. A empresa colabora com médicos-cientistas para atender às necessidades dos pacientes e às limitações das terapias existentes, garantindo que suas soluções sejam projetadas para os pacientes e impulsionadas por um profundo senso de propósito. A Nuvalent está comprometida em usar sua expertise para oferecer tratamentos contra o câncer precisamente direcionados.

Descrição

• 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). • 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. • 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.

🎯 Requisitos

• 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).

🏖️ Benefícios

• medical, dental, and vision insurance • 401(k) retirement savings plan • generous paid time off (including a summer and winter company shutdown)