Senior Director or Director, Clinical Pharmacology

Direct Hire Full-Time Role

Pay Rate: $120 - $130 per hour

Location: Palo Alto, CA - Hybrid Role

Job Summary:

We are seeking a dynamic and experienced Senior Director or Director, Clinical Pharmacology, who will play a critical role in supporting the Head of Clinical Pharmacology to advance our therapeutic candidates. This role will lead the design and execution of clinical pharmacology studies, providing pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data to inform clinical development programs. The ideal candidate will collaborate cross-functionally with clinical development, regulatory affairs, and translational research teams to support the progression of our diverse pipeline from early-phase trials through regulatory submission.

Duties and Responsibilities:

• Lead the design and execution of clinical pharmacology studies, including PK/PD, dose-escalation, bioavailability, bioequivalence, and drug-drug interaction studies, under the strategic direction of the Head of Clinical Pharmacology and Pharmacometrics.
• Conduct analysis and interpretation of PK/PD data and biomarker results to support dose selection, safety, and efficacy evaluations.
• Provide clinical pharmacology expertise to support regulatory submissions (IND, NDA, BLA) and interactions with global regulatory agencies (FDA, EMA, etc.).
• Work closely with clinical development, translational research, biostatistics, and regulatory teams to integrate clinical pharmacology data into development plans.
• Apply PK/PD modeling and simulation to support optimization of dosing regimens and prediction of clinical outcomes.
• Support management of relationships with CROs, academic collaborators, and other external partners for clinical pharmacology activities.
• Contribute to a high-performing clinical pharmacology team, fostering a culture of scientific excellence and innovation.
• Ensure all clinical pharmacology activities comply with GCP, ICH guidelines, and other relevant regulatory standards.

Requirements and Qualifications:

• PhD, PharmD, or MD with a focus on clinical pharmacology, pharmacokinetics, or a related field.
• Minimum of 8 years of experience in clinical pharmacology within the biopharmaceutical industry.
• Strong experience in the development of diverse therapeutic modalities, including biologics (e.g., monoclonal antibodies, protein therapeutics) and other drug classes.
• Demonstrated experience leading the design and execution of clinical pharmacology studies for early- and late-phase clinical trials.
• Knowledge of regulatory requirements for clinical pharmacology (FDA, EMA, etc.).
• Proficiency in PK/PD modeling and simulation tools (e.g., NONMEM, R, Phoenix WinNonlin, or similar).
• Strong analytical and problem-solving skills, with a focus on data-driven decision-making.
• Excellent communication and presentation skills, with the ability to convey complex scientific concepts to diverse audiences.
• Collaborative mindset with a track record of successful cross-functional teamwork.

Preferred Qualifications:

• At least 3 years of experience in oncology therapeutics.
• Experience with antibody-drug conjugates (ADCs), bispecific antibodies, or other complex therapeutic modalities.
• Familiarity with biomarker development and translational research.
• Prior contributions to regulatory submissions (IND, BLA, or equivalent).

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