The Associate Director/Director/Sr. Director, Clinical Pharmacology develops and executes Clinical Pharmacology and Pharmacometrics strategies across the portfolio; as a key team member and clinical pharmacology lead to participates in the design of clinical studies; and interprets, presents, and reports clinical Pharmacology study results. The incumbent works cross-functionally with internal departments and external resources as part of drug development teams.
The Associate Director/Director/Sr. Director, Clinical Pharmacology supports adherence to relevant regulatory requirements, and builds company Standard Operating Procedures (SOPs) as appropriate.
Acts as the lead clinical pharmacologist for multiple clinical stage programs.
Develops an overarching clinical pharmacology strategy from IND to NDA (or BLA) to support regulatory submissions.
Predicts human Pharmacokinetic (PK) parameters and exposure profiles using in vitro and animal PK data.
Estimates the Maximum Recommended Starting Dose (MRSD) based on toxicology study results for the First-In-Human (FIH) clinical trials.
Implements optimal dose-finding strategies to ensure safe and effective advancement of clinical programs.
Designs and oversees clinical pharmacology studies to evaluate PK in special populations. This includes, but may not be limited to, pediatric and geriatric patients or those with renal and hepatic impairments as examples.
Designs clinical drug-drug interaction and food effect studies following regulatory guidance.
Drafts Investigator’s Brochures (IBs), eCTD modules, and clinical study protocols in close partnership with clinical operations, medical, regulatory, biostatistics, and medical writing professionals.
Performs PK analyses in non-compartmental model for the drug and/or metabolites.
Performs population PK/PD analyses and integrates this knowledge into the overall clinical development strategy(ies).
Evaluates and selects Contract Research Organizations (CROs) and manages/actively oversees outsourced PK, PK/PD, and exposure-response analyses.
Basic Education/skills/ability required:
Minimum level of education and years of relevant work experience.
PhD in a relevant scientific discipline OR a PharmD degree
A minimum of 5 years or more of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education.
Special knowledge or skills needed and/or licenses or certificates required.
Highly proficient in performing PK clinical study design and analysis.
Demonstrated expertise in developing and executing drug metabolism and pharmacokinetics studies.
Demonstrated understanding or, and experience applying, clinical pharmacology concepts.
Strong experience with common PK/PD modeling software packages (such as Phoenix WinNonlin).
Demonstrate understanding of formulation and toxicology.
Familiar with regulatory guidance especially for drug interaction studies.
Experience managing multiple projects with competing priorities.
Demonstrated experience in writing study reports and regulatory documents.
Ability to discuss and influence without direct authority.
Excellent verbal and written communication in English, and in Chinese is a big plus.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Excellent management and interpersonal skills.
Special knowledge or skills and/or licenses or certificates preferred.
Experiences in oncology therapeutic fields is a big plus.
Experiences in multiple modalities (small molecules and biologics).
Experience with common PBPK modeling software (such as GastroPlus).
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