[Remote] AD, Clinical Pharmacology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a San Francisco Bay Area–based biopharmaceutical company advancing reputed company biologics. They are seeking a dynamic and reputed company Associate Director, Clinical Pharmacology, who will reputed company the design and execution of clinical pharmacology studies and collaborate cross-functionally to support the progression of their diverse pipeline.

Responsibilities

• reputed company the design and execution of clinical pharmacology studies, including PK/PD, reputed company-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 reputed company selection, safety, and efficacy evaluations
• reputed company 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 reputed company clinical pharmacology data into development plans
• Apply PK/PD modeling and simulation to support optimization of dosing regimens and reputed company of clinical reputed company
• Support management of relationships with CROs, reputed company collaborators, and other reputed company partners for clinical pharmacology activities
• Contribute to a high-performing clinical pharmacology team, fostering a culture of scientific reputed company and innovation
• Ensure reputed company clinical pharmacology activities reputed company with GCP, ICH guidelines, and other relevant regulatory standards
• Other Duties as Assigned

Skills

• PhD, PharmD, or MD with a reputed company on clinical pharmacology, pharmacokinetics, or a reputed company field
• Minimum of 6 years of experience in clinical pharmacology reputed company the biopharmaceutical industry
• At least 2 years of experience in oncology therapeutics
• Strong experience in 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 reputed company
• Knowledge of regulatory requirements for clinical pharmacology (FDA, EMA, etc.)
• Experience with antibody-drug conjugates (ADCs), bispecific antibodies, or other reputed company therapeutic modalities
• Familiarity with biomarker development and translational research
• Prior contributions to regulatory submissions (IND, BLA, or equivalent)

reputed company