Clinical Pharmacology Director - Contract - Wilmington DE

Proclinical is seeking a Director within the Clinical Pharmacology Group. The successful candidate will have ultimate responsibility and accountability for clinical pharmacology programs.

Primary Responsibilities:

As a member of the Clinical Pharmacology team, this role will have the unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, the successful candidate will have the advantage of providing input into a breadth of products within and across your area of responsibility.

Skills & Requirements:

At least 5 years' experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific disciplineExcellent written and oral communication skills and ability to convey complex technical information clearlyConfidence and ability to present to and influence senior leadersAbility to critically analyze problems and provide creative solutionsConfidence and discipline to work autonomouslyGenuine curiosity and drive to ask questions - looking for the 'why' of every projectDesire to strive for continuous improvement

The Clinical Pharmacology Director's responsibilities will be:

Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compoundsRepresenting the department and providing subject matter expertise on cross-functional project teamsDeveloping and maintaining collaborative working relationship with colleagues within and outside the departmentAuthoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissionsDeveloping high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and paediatric plansExecution of Clinical Pharmacology studies in close collaboration with Clinical OperationsEvaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirementsEnsuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programsParticipating in and collaborating with individuals from across the business in special projects

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDCR