VP Clinical Pharmacology - San Diego, California
Position Summary: In close collaboration with the Chief Medical Officer, the Vice President, Clinical
Pharmacology will spearhead the assembly and direction of a proficient team of clinical
pharmacologists. Their role encompasses the development and execution of the company's clinical
pharmacology strategies across the spectrum from pre-clinical to clinical development and eventual
drug approval. Proficiency in pharmacokinetic theory, compartmental modeling and simulation, as
well as adeptness with cutting-edge computational tools, underpins their approach.
* Foster and oversee a team of clinical pharmacology leaders, devising strategies to optimize
departmental performance, foster growth, and inspire innovation.
* Execute gap analyses and provide guidance in the evolution of clinical pharmacology
methodologies to bolster clinical drug development for pipeline assets.
* Provide stewardship in the formulation and scrutiny of clinical pharmacology study
protocols. This encompasses active involvement in clinical trials,
pharmacokinetic/pharmacodynamic modeling, and comprehensive analyses. Additionally,
spearhead the clinical pharmacology aspects of regulatory engagements.
* Champion and advocate for the application of progressive clinical pharmacology and model-
based drug development (MBDD) methodologies.
* Cultivate networks and engender collaborative efforts with cross-functional teams, aligning
efforts to achieve project team and corporate objectives.
* Manage budgetary planning for clinical pharmacology activities, including vendor selection,
outsourcing of PK, PK/PD analyses, and contract requisition.
* Foster collaborations with corporate partners in coalesced drug development endeavors.
* Take the lead in conducting functional area assessments for due diligence evaluations.
* Drive external visibility and champion publication objectives.
* Possession of a Ph.D. degree in Pharmaceutical Sciences, Pharmacology, or a related
* Accumulated 10+ years of pertinent Clinical Pharmacology experience in the biotechnology
or pharmaceutical sector, with a substantial 5+ years in Clinical Pharmacology leadership
* Demonstrated proficiency in drug development evidenced by notable contributions to
successful INDs, Regulatory Agency interactions, NDAs/BLAs, drug approvals, in-licensing
deals, and/or peer-reviewed publications.
* Up-to-date familiarity with FDA regulatory guidelines concerning nonclinical and clinical
pharmacology, including a history of direct interactions with regulatory agencies,
encompassing the submission of IND, NDA/BLA, and other regulatory documents.
* Thorough understanding of, and adherence to, regulatory, protocol, standard operating
procedures, as well as proficiency in Good Laboratory Practices (GLP) and Good Clinical
Practices (GCP) as applicable.
* Hands-on experience in utilizing modeling software, coupled with a familiarity with statistical
approaches and programs for comprehensive data analysis.
* Proven capability in scientific writing and delivering impactful presentations.
* Strategic leadership prowess, demonstrated by the ability to inspire, mentor, and adeptly
* Outstanding communication and interpersonal skills, affording the capacity to collaborate
seamlessly with both internal and external stakeholders.
* Strong analytical acumen and adeptness in problem-solving, underscored by a discerning
* Willingness and ability to travel as required by the position.
TGI Life Sciences is acting as an Employment Agency in relation to this vacancy.