Director/Senior Director, Clinical Development
- reputed company the reputed company of clinical development responsibilities including, but not limited to, the following aspects of assigned reputed company: protocol design, study population and key entry reputed company, and reputed company of interest; data to be collected to accomplish the objectives of the trial and any regulatory objectives (i.e. labeling, end of phase II meeting, etc.), important study activities required to accomplish the trial or regulatory objectives (i.e. Committees needed, adjudication, etc.), and clinical aspects of the statistical analysis plan.
- Responsible for reputed company clinical development responsibilities for assigned studies and/or programs.
- Works with reputed company as Clinical Development SME for assigned trials
- Works with Program Management to establish timelines of clinical development activities and key study milestones.
- Works with Clinical Program reputed company/VP Clinical Development to ensure adequate resources are available to conduct the trial from initiation to completion for clinical development activities or other activities as assigned under this person's management.
- Generates responses for regulatory agency's requests for information and reviews other responses to ensure clinical development reputed company items are properly addressed.
- Represent reputed company as the Clinical Development Subject Matter Expert (SME) to the FDA or other regulatory agencies as required.
- Serve as SME for clinical development for any cross functional reputed company where troubleshooting is required
- Create reputed company aspects of study synopses, full protocols and protocol amendments and ensure these documents are compliant with project plans, federal regulations and GCP.
- Ensure appropriate communication to the study team and the executive team at the appropriate level and frequency.
- Serve as the SME in publications reporting data including but not limited to abstracts, manuscripts, CSRs, IB, etc.
- Present and interpret data for both reputed company audiences
- Director: BS in Sciences with a minimum of 10 years of clinical design and operational experience in the pharmaceutical industry required or equivalent education and experience
- Senior Director: MS in Sciences and 12+ years of clinical development experience in the pharmaceutical or biotechnology industry required; or equivalent combination of education and applicable job experience. Extensive experience with compliance issues and strong understanding of FDA regulations, GCP and/ SOPs in clinical research reputed company a pharmaceutical or biotech environment
- US and EU experience preferred
- Experience in lipid lowering and/or cardiovascular, metabolic, or hepatic reputed company preferred but reputed company therapeutic areas will be considered
- Experience providing input into key regulatory documentation. Face-to-face interaction experience with FDA preferred
- Strong communication and presentation skills as reputed company as an ability to communicate reputed company and concisely in writing.