Senior Director, Drug Metabolism and Pharmacokinetics

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🕒 vor 2 Monaten

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $270.000 - $295.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Direktor

Jetzt Bewerben

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Nuvalent, Inc.

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11 - 50 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Nuvalent, Inc. ist ein Biotechnologieunternehmen, das sich auf die Entwicklung gezielter Therapien für Krebspatienten konzentriert. Mit einer soliden Basis in der Chemie und der strukturorientierten Arzneimittelforschung entwirft Nuvalent innovative kleine Moleküle, um Kinase-Ziele effektiv zu hemmen und Herausforderungen hinsichtlich Resistenz und Selektivität zu überwinden. Das Unternehmen arbeitet mit forschenden Ärzten zusammen, um Patientenbedürfnisse und die Grenzen bestehender Therapien zu adressieren, wobei ihre Lösungen patientenorientiert und von einem tiefen Sinn für Zweckmäßigkeit getrieben sind. Nuvalent verpflichtet sich, seine Expertise zu nutzen, um präzise zielgerichtete Krebsbehandlungen bereitzustellen.

Beschreibung

• 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.

🎯 Anforderungen

• 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).

🏖️ Vorteile

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