Director, Clinical Pharmacology at Vertex
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POST DATE 9/18/2016
END DATE 10/13/2016
JOB DESCRIPTIONThe Associate Director / Director, Clinical Pharmacology manages strategic, scientific and operational aspects of programs from the clinical pharmacology perspective. He/she represents the department on strategic and operational cross-functional program teams, providing direction and guidance for clinical pharmacology plans. He/she assists in departmental management through program reviews and collaborative decision-making. He/she routinely supervises and mentors more junior staff, providing career development, routinely co-leads cross-functional efforts and leads department initiatives.
As the Clin Pharm Program Lead, the candidate will work closely with other functional experts across the organization, such as Modeling & Simulation, DMPK, Pharm Dev, Biomarkers, Medical and Clinical Operations.
This position will report into the Head of Clinical Pharmacology & Biomarkers.
Representation and/or leadership on strategic and operational cross-functional teams
Responsible for clinical pharmacology plans including drug-drug interaction, special population and safety studies
Create protocol concepts and guide protocol start-up including site initiations and investigator meetings
Oversee program progression including protocol conduct, data analyses, internal decision points and external regulatory interactions
Oversee and contribute to regulatory and safety documents
Collaborate with other functions to guide program deliverables
Provide expert input for internal review cycles
Responsible for clinical pharmacology summary documents
Guide PK analyses
Perform PK/PD or exploratory analyses or guide such analyses as appropriate
Work closely with colleges in Modeling & Simulation to ensure appropriate quantitative efforts to support the program
Maintain a high standard for good clinical practice, compliance and ethics