Director/Senior Director Clinical Pharmacology

Director/Senior Director Clinical Pharmacology
Company:

(Confidential)


Director/Senior Director Clinical Pharmacology

Details of the offer

The Director/Senior Director of Clinical Pharmacology will be responsible for developing, driving, and implementing (with internal collaborations and working with consultants/external partners) global Clinical Pharmacology strategies across multiple indications. You will be a core member of the program teams providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and internal collaborations to help execute programs. The successful candidate will bring extensive experience in clinical pharmacology and work cross:functionally with research and clinical teams to drive programs to success. We are BrighterTogether
How you will spend your day:
Develop and execute modeling and simulation plans; use model:based approaches to improve the efficiency of drug development and support dose selection and optimization.
Responsible for ensuring/performing appropriate PKPD analysis including population PK, PKPD modeling and simulation, meta:analysis, and disease modeling as required by the program to aid in dose selection, trial design, and/or program decision:making.
Design, implement, drive, and monitor Clinical Pharmacology strategies.
Work with internal teams and external partners to execute program team objectives.
Contribute to program strategy, protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation; write and review clinical pharmacology summary documents.
Oversee vendors and consultants as appropriate
Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures. Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
Accountable and responsible for analysis of PK data Directs the planning of all relevant PK:PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with translational science and statistics (as relevant).
Things about you:
PhD in Pharmacokinetics or Pharmaceutical Sciences, or related field required.
A minimum of 10 years experience in the biopharma industry in a Clinical Pharmacology role with at least 5 years in Oncology and proven ability to represent Clinical Pharmacology on project teams and with external partners.
Experience with NDA or BLA Oncology submissions and regulatory interactions
Experience partnering with DMPK and translational science colleagues to ensure relevant clinical pharmacology strategy is developed.
Experience working cross:functionally and working with external partners.
.Strong knowledge of the role of clinical pharmacology in drug development, including the application of translational pharmacology as well as model:based approaches.
Ability to perform in fast:paced, dynamic, constantly evolving environment.
Excellent communication and organizational skills and attention to detail.
Strong time management skills; ability to prioritize multiple tasks efficiently.


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