Manager or Director, Clinical Pharmacology

Position Summary:  

The Clinical Pharmacology Lead is responsible for providing clinical pharmacology expertise to the cross functional product development team and contributing to clinical development through advancing MIDD (Model Informed Drug Development) initiatives. The core job responsibilities include analysis, interpretation and reporting of clinical PK and PK/PD data, preparation and review clinical pharmacology data for regulatory submissions. In addition to the Clinical Pharmacology Lead responsibilities, this position also serves as DMPK Lead through collaboration with research team on non-clinical DMPK, and translational pharmacology activities. 

Essential Duties and Responsibilities:

• Provide clinical pharmacology expertise to the cross functional product development team.
• Conduct data analyses including non-compartmental PK analyses, pop PK, and ER analyses.
• Design and execute clinical pharmacology studies (eg, food effect, DDI, AME/Mass Balance studies).
• Co-author regulatory documents such as protocol, study report, healthy authority briefing book, and IB.
• Collaborate with research team on non-clinical DMPK and translational pharmacology activities.
• Manage external CROs to ensure compliance with planned study protocols, deliverables, internal quality control standards, and timelines.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Required Education and Experience:

• PhD or PharmD with training in relevant fields such as pharmaceutical sciences, clinical pharmacology, and/or engineering. No prior industrial working experience is required for the Manager level position; a minimum of 7 years of relevant working experience is required for the Director level position.
• Solid knowledge and experience in pharmacokinetics, pharmacodynamics, and drug metabolism.
• Proficient in using WinNonlin, NONMEM, R, and other modeling and simulation software.
• Working experience in preclinical and clinical development of investigational drugs in diverse platforms including small molecules and biologics.
• Proven track record in authoring DMPK and Clinical Pharmacology components of regulatory documents.
• Excellent collaboration, communication, and interpersonal skills.
• Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced and dynamic, team-oriented environment.

The anticipated salary range for this position is $190,000 to $245,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.