Clinical Pharmacology & Pharmacometrics Director
Location: Boston, MA
Contact: Janene Cleary, jd@bandishgroup.com
THE ROLE:
Clinical Pharmacology & Pharmacometrics Director | Leading Global Biopharmaceutical Company
DESCRIPTION:
This Clinical Pharmacology & Pharmacometrics Director search is being conducted on behalf of our global biopharmaceutical client who is pushing the boundaries of science to deliver life-changing medicines. They are resetting expectations of what a biopharmaceutical company can be. They are opening new ways to work, groundbreaking and cutting-edge methods and bringing unexpected teams together.
This is a scientific role that works closely with the clinical team to create a clinical pharmacology development program. This role provides differentiated medicine and the right dose to patients. You will apply state-of-the-art Clinical Pharmacology and Model-informed Drug Development (MIDD) approaches to influence study designs and internal/external decision making at the project level.
As a Director, one will be accountable for planning and implementing innovative clinical pharmacology programs with direct value on specific projects including go/no-go decision making. You will be responsible for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at internal (project/governance) and external interactions (investigator meeting/conference/health authorities). You will also contribute to the identification and development of drug-disease models and other modeling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant).
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
Our client is committed to doing the right thing by putting patients first.
One should have international scientific reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology
The ideal candidate will have an understanding of early and late stage drug development and experience with relevant software and tools within the field of MBDD (e.g. SIMCYP, R, NONMEM) (T)
HIGHLIGHTS OF RESPONSIBILITIES:
Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at internal (project/governance) and external interactions (investigator meeting/conference/health authorities).
Jointly accountable with the pharmacometrician for providing a scientific justification for the dose selection.
Contribution to the identification and development of drug-disease models and other modelling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant).
Support evaluation of candidates for in/out-licensing.
DESIRED SKILLS AND QUALIFICATIONS:
Expert knowledge of pharmacokinetics and Model-InformedDrug Development (T).
Expert knowledge in pharmacology, drug targets and core disease areas (T,D).
Demonstrated broad translational and clinical development expertise and experience exemplified by at least 6 years of drug development experience, with emphasis on Clinical Pharmacology.
Demonstrated ability to identify, develop and execute clinical pharmacology activities at a project level.
A demonstrated knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology (T).
PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required.
Relevant regulatory experience (written/oral).
Training and experience with PK software (Phoenix, WinNonlin).
CONTACT:
Janene Cleary, Director Life Sciences Recruiting
Phone: 267-483-5233 ext. 103
Email: jd@bandishgroup.com
The Bandish Group, LLC
Life Sciences Executive Search
Greater Philadelphia Region
www.bandishgroup.com