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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

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

�� 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 s.amark@proclinical.com

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

�� Staffing is an equal opportunity employer.

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