VP Clinical pharmacology

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.

Responsibilities:

* 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.

Qualifications:

* Possession of a Ph.D. degree in Pharmaceutical Sciences, Pharmacology, or a related

discipline.

* Accumulated 10+ years of pertinent Clinical Pharmacology experience in the biotechnology

or pharmaceutical sector, with a substantial 5+ years in Clinical Pharmacology leadership

roles.

* 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

manage teams.

* 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

strategic mindset.

* Willingness and ability to travel as required by the position.

TGI Life Sciences is acting as an Employment Agency in relation to this vacancy.