Senior Director/Vice President, Clinical Pharmacology

Senior Director/Vice President, Clinical Pharmacology

Senior Director/Vice President, Clinical Pharmacology
Tracking Code
11-53
Job Description

Infinity is seeking a motivated individual to lead the clinical pharmacology function for its small molecule drug candidates.  He/she will be responsible for all aspects of clinical pharmacology relating to the development of drug candidates and for working with colleagues from clinical and nonclinical disciplines to ensure innovative clinical strategy, model- based drug development, optimal use of all available information, optimal dose selection and delivery of clinical pharmacology studies.  This individual will be an active member of Infinity's Research and Development Team and responsible for establishing and maintaining strong relationships with nonclinical pharmacology, chemistry, pharmaceutical development, toxicology and clinical development groups to ensure program goals are achieved.
Responsibilities include:
* Development and execution of the Clinical Pharmacology strategy for a given program(s) from candidate selection through registration.
* Plan, design and oversee clinical pharmacology development plans and represent the clinical pharmacology function in the design, analysis and interpretation of clinical pharmacokinetic and pharmacodynamic studies. 
* Lead/contribute to the planning of studies that generate PK-PD data and lead the integration of analyses involving PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
* Accountable and responsible for analysis of PK and PD data and accountable for ensuring appropriate PK-PD analyses are conducted, including population PK, PK-PD modeling and simulation.
* Conduct individual clinical pharmacology studies as required throughout all stages of drug development with operational assistance from Clinical Operations.
* Coordinate with team members in the review, analysis and reporting of data from clinical pharmacology studies.  Responsible, in conjunction with other team members, for content and accuracy of study report prior to final sign-off. 
* Lead or participate in clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, NDA/MAA.  Participate or take a lead role in writing and reviewing clinical pharmacology queries from regulatory agencies.
* Provide clinical pharmacology expertise to Discovery and Pharmaceutical Development as appropriate through collaborating with internal team members to define and generate in vitro and in vivo data to support clinical pharmacology studies. 
* May participate in multidisciplinary teams in assessing potential in-licensing opportunities as requested by senior management.
Requirements:
* PharmD, PhD or MD/PhD in an area relevant to clinical pharmacology with a proven record in drug development from IND through regulatory submission and commercialization
* Demonstrated accomplishments in experimental design, regulatory considerations and clinical execution of clinical PK/PD studies
* Experience with integration of population PK/PD, modeling and simulation and model-based drug development into clinical development plans
* Strong data analysis skills and an in-depth knowledge of pharmacokinetic and pharmacodynamic principles, including their application in clinical research and drug development. 
* Comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines
* Ability to produce and present quality scientific presentations at internal or external meetings.
* Excellent verbal and written communication and presentation skills
* Demonstrated ability to work effectively in a matrix, team environment, manage multiple priorities and exercise sound judgment
* Must have experience developing teams , be recognized as a strong leader and have proven experience working at the senior management level
* Title will be commensurate based on experience
Job Location
Cambridge, MA, US.
Position Type
Full-Time/Regular