Vice President, Clinical Pharmacology and DMPK

THE ROLE

The Clinical Pharmacologist will be principally responsible for leading clinical pharmacological strategy as well as directly managing group deliverables. Additionally, the incumbent must drive key performance for the optimization of clinical pharmacological data, strategic business alignment, and organizational success. The person will work collaboratively with other functional leaders in the achievement of departmental and corporate objectives and initiatives. This position reports directly to the Chief Medical Officer.

Duties and Responsibilities:

• Primarily responsible for the development and execution of all clinical pharmacology strategies.


• Complete oversight of all clinical pharmacology activities for the organization.


• Provide preclinical DDI work related to the clinical pharmacology strategy, and clinical pharmacology support for administrative activities and the identification of other indications.


• The incumbent must have an in-depth understanding of IND enabling PKDM studies.


• Build and lead a highly effective, innovative clinical pharmacology function inclusive of management of internal resources and external consultants that will facilitate data driven decision making and can support regulatory requirements for safety and efficacy


• Experience with clinical development of a pharmaceutical product from start to finish including designing and reviewing clinical pharmacology study protocols, supporting clinical trials, development and application of population PK,PK/PD, exposure-response and other models, and incorporating findings into study reports and regulatory documents, and participating directly in regulatory interactions.


• Drive key performance for the optimization of clinical pharmacological data and ensure execution of key deliverables in a timely manner.


• Qualified candidates will have the ability to work on a variety of therapeutic indications and data types and must be experts in applied Population PK, PK/PD, and/or exposure- response modelling and simulation to support drug development.


• A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs, Regulatory Agency interactions, NDAs, drug approvals, in-licensing deals, and/or peer reviewed publications.


• Current knowledge of FDA regulatory guidance related to nonclinical PKDM and clinical pharmacology.


• Manage clinical pharmacology activities related to budget planning, vendor identification, outsourcing of PK, PK/PD analyses and contract requisition.


• Direct and coordinate processes for bioanalytics.


• Need to be a team player with the other functions within the organization with research, CMC, clinical and transitional medicine.


• Attract, retain, mentor and develop clinical pharmacology team members.

Supervisory Responsibilities:
This position will have oversight of Nonclinical PKDM and Clinical Pharmacology.

Education/Experience:

• PhD, PharmD or equivalent degree in pharmaceutical sciences, pharmacology or a related discipline and a minimum of seventeen years of related experience in Biotech/Pharma industry.