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 discipline
- Excellent written and oral communication skills and ability to convey complex technical information clearly
- Confidence and ability to present to and influence senior leaders
- Ability to critically analyze problems and provide creative solutions
- Confidence and discipline to work autonomously
- Genuine curiosity and drive to ask questions - looking for the 'why' of every project
- Desire 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 compounds
- Representing the department and providing subject matter expertise on cross-functional project teams
- Developing and maintaining collaborative working relationship with colleagues within and outside the department
- Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
- Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and paediatric plans
- Execution of Clinical Pharmacology studies in close collaboration with Clinical Operations
- Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
- Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Participating 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.
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