This job has expired

VP Clinical pharmacology

TGI Life Sciences
California, USA, San Diego
Start date
27 Sep 2023
Closing date
18 Oct 2023

View more

R & D , Pharmacology
Full Time
Contract Type
Experience Level
Senior Management

Job Details

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

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.


TGI Life Sciences is a highly effective recruitment partner that offers their clients more than just a service provider. We achieve this with highly experienced consultants that seek to understand each and every clients growth and development goals.

Our critical success factors are simple, we identify, attract and secure highly specialised technical professionals.

Our main areas of expertise are helping overseas businesses recruit into the US and Europe. This is typically within the drug development stage, and cover the full spectrum in the development process. 

Company info
TGi Life Sciences
Regus Building, Churchill Court
United Kingdom

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