Director, Clinical Pharmacology

Want to use specialized AI just for BioPharma to compete for this highly desirable role? Check out our updated tool https://jobsai.medicinetomarket.com today!

Role Summary

Director, Clinical Pharmacology leads PK/PD strategy across multiple development programs, guiding study design, data analyses, protocol and report writing, regulatory dossier preparation, and scientific publications. The role includes communicating with senior and executive management, regulatory agencies, and external peers; mentoring direct reports; and driving cross-functional collaboration, strategic planning, and due diligence to advance drug development. The position emphasizes applying scientific expertise to interpret data for decision making and maintaining current PK/PD knowledge.

Responsibilities

• As a lead clinical pharmacologist for multiple projects, develop PK/PD strategy, lead activities (e.g. study design, data analyses/interpretation/presentation, protocol & report writing, regulatory dossier preparation, scientific publications), identify & resolve issues, communicate/present/influence senior & executive management, regulatory agencies, & external peers.
• Support strategic planning for drug development activities.
• Utilize scientific expertise to provide appropriate interpretation of data & relate implications of results to management for decision making.
• Ensure efficient cross-functional collaboration.
• Maintain scientific knowledge & influence/drive department goals.
• Conduct independent due diligence reviews.
• Mentor & manage direct reports.

Qualifications

• PhD in Pharmacokinetics, Pharmaceutical Sciences, or a closely related field & 2 years of academic or industry experience contributing to drug development research with respect to PK/PD & clinical pharmacology. Of the experience required, must have 1 year: (i) investigating, identifying, developing, & optimizing new methods & techniques in the PK/PD field; (ii) authoring study protocols, study reports, & PK/PD analyses reports; (iii) conducting data analyses including non-compartmental analyses, population PK, PBPK, exposure-response, QSP, & other PK/PD modeling & simulations using Phoenix WinNonlin, R, NONMEM, & Symcyp; (iv) managing multiple projects & working in cross-functional teams; & (v) publishing peer reviewed articles in scientific journals & presenting work at PK/PD conferences.
• Alternatively, would accept a PharmD & 4 years of academic or industry experience contributing to drug development research with respect to PK/PD & clinical pharmacology. Must also have 4 years of (i), (ii), (iii), (iv) & (v).
• Work experience may be gained concurrently. Would accept reasonable combination of academic, training and work experience.