Director - Clinical Pharmacology - Proclinical Staffing : Job Details

Director - Clinical Pharmacology - Permanent - Jersey, USA (Remote)

Proclinical is seeking an experienced Clinical Pharmacologist to join an innovative biotech company, supporting one of their latest assets to hit the clinic.

Primary Responsibilities:

The successful candidate will provide strategic and scientific expertise, represent Clinical Pharmacology (CP) in a dynamic cross-functional clinical development team, and collaborate with both internal and external stakeholders to execute CP strategies. This position offers the unique opportunity to participate in the rapid growth of a biotech startup.

Skills & Requirements:

• Advanced degree (PhD, PharmD, or MD) with training in CP, PKPD, Pharmacology, and Pharmaceutical Sciences.
• Experience in the application of CP within drug development in the healthcare industry.
• Expertise with monoclonal antibodies programs and TMDD modeling.
• Proficiency with PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection.
• Hands-on experience using pharmacometrics (PMx) tools and software (e.g., WinNonlin, NONMEM, and R) for individual and population PK analysis, modeling, and simulations.
• Knowledge of current practices and regulatory requirements in clinical development, bioanalysis, biopharmaceutics, pharmacology, toxicology, and formulation development.
• Excellent written and oral communication skills with attention to detail.
• Strong desire to work in a dynamic, interactive, fast-paced, and innovative environment.
• Natural collaborator who enjoys working on a cross-functional team.

The Director - Clinical Pharmacology's responsibilities will be:

• Develop and maintain comprehensive CP strategic development plans for assigned clinical development programs/studies.
• Provide CP subject matter expertise to the clinical study team/development team.
• Draft and finalize CP-related report templates, as well as data handling and analysis standard operating procedures (SOP).
• Participate in the drafting, review, and finalization of clinical study protocols and study analysis plans (SAP).
• Supervise and/or conduct pharmacokinetic/pharmacodynamic (PKPD) analyses.
• Draft, review, and finalize CP study reports and publications, working with Medical Writers to incorporate PKPD sections into clinical study reports (CSR).
• Collaborate with Regulatory to provide CP support for regulatory documents, communications, and presentations as needed.
• Work closely with Quantitative Pharmacology (QP) colleagues to develop and deliver quantitative strategies to support assigned development plans.
• Assist the Statistics, Data Management, Clinical, Preclinical/Nonclinical, Bioassay, and other functions as needed.

Compensation:

• Salary ranges from $200 000.00 - $240 000.00 per annum

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at [email protected]

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.