Associate Director, Clinical Pharmacology

About the Role

The Associate Director of Clinical Pharmacology will oversee all aspects of clinical pharmacology for candidate drug products from early development (pre-IND) through late-stage development (Phase 3 and NDA filings). This role utilizes pharmacokinetic, pharmacodynamic, DMPK, and drug therapeutic principles, along with knowledge of drug regulatory processes. As a key member of the Translational Medicine & Clinical Pharmacology group, you will represent clinical pharmacology on cross-functional teams, oversee study execution, and conduct analyses independently or through CROs.

Responsibilities

• Contribute to clinical pharmacology and research plans, design and direct nonclinical PK and clinical pharmacology studies, and collaborate cross-functionally to establish study protocols.
• Generate hypotheses and strategies for nonclinical PK and clinical pharmacology study types; create study protocol concepts and guide study start-up activities.
• Participate in study teams, providing scientific leadership in study progression, including protocol conduct, data analyses, internal decision points, and final reporting.
• Independently write nonclinical PK and clinical PK sections in study reports; lead authoring of DMPK and clinical pharmacology summaries in regulatory documents (e.g., protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, responses to queries).
• Serve as a resource for nonclinical pharmacokinetics/toxicokinetics, drug metabolism, and clinical pharmacology within development organizations and to regulatory authorities.
• Participate in writing publications and making scientific presentations aligned with development strategies.
• Maintain knowledge of relevant scientific and regulatory practices and trends to ensure contemporary clinical pharmacology aspects of development programs.
• May manage internal staffing and performance, including hiring, training, coaching, and performance reviews; mentors and develops staff.

Requirements

• Bachelor’s or Master’s degree in a scientific discipline is required; PhD in pharmacokinetics, pharmacology, pharmacy, pharmaceutical sciences, or a closely related discipline is preferred. Equivalent experience may also be considered.
• PharmD or PhD with 5+ years of relevant experience, or MS with 8+ years of relevant experience.
• Direct experience in creating regulatory submissions; experience interacting with regulatory authorities is desired.
• Experience across multiple drug development phases is highly desired.
• Proficiency with specialized software for pharmacokinetic data analysis, statistical software, and tools for graphical output and reporting.
• Understanding of the autoimmune therapeutic area and biologics is highly desired.

Skills

• Excellent written and verbal communication skills.
• Leadership, initiative, and commitment to excellence.
• Ability to work in a cross-functional drug development team environment and lead such teams.

Pay

Nektar anticipates the base salary for this role to range from $185,000 to $220,000 for candidates in the Bay Area, depending on location and qualifications. This position is also eligible for an annual performance bonus at the Company’s discretion.

Benefits

• Health Insurance (Medical, Dental, Vision)
• Disability Insurance
• Holiday Pay
• Paid Time Off (PTO)
• 401(k) Match
• Employee Stock Purchase Plan
• Wellness Programs
• Parental Leave Benefits (in accordance with applicable plans)