Job Description:
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Job Title: Director, Clinical Research and Development
Description
We are currently seeking a key MD to join our Clinical Group and provide clinical leadership to our Cardiovascular Development Programs. The Clinical Director reports to our Chief Medical Officer/SVP Clinical Research and Development. He/she will be chartered to provide medical guidance and leadership to all aspects of product development including clinical advisory board management, protocol design, clinical trial site recruitment/implementation and monitoring; as well as data interpretation and reporting. He/she will also support IND, Phase I-III and NDA submissions. Duties: • Serves as a source of medical expertise for cardiovascular project teams. • Provides input to decisions that have medical, scientific, and future marketing implications. • Is responsible for the medical input to design, planning, initiation and completion of clinical trials. • Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions. • Responsible for establishing communications with prominent clinical investigators in the areas of and cardiovascular medicine. • Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events. • Applies the strategic intent of the Company when working with regulatory bodies such as FDA, and with opinion leaders. • Performs product safety medical reviews for assigned investigational drugs. • Ensures an appropriate level of customer service to internal and external customers.
Requirements
• MD degree with board certification in internal medicine with minimum of 3 years in clinical development experience in a biotechnology or pharmaceutical company. We would consider candidates with less/more industry experience at Associate Director/Sr. Director levels. • Sub-specialty training and prior industry experience in the clinical development of cardiovascular therapeutics. • Strong understanding of human pharmacology, biochemical medicine and pharmacodynamic/clinical endpoints. • Expertise in clinical trials design and related statistical issues. • Knowledge of CDER regulations/ICH guidelines. • Understanding of pharmaceutical safety reporting and surveillance requirements. • Excellent verbal and written communication skills and presentation skills. • Strong interpersonal skills. • Leadership skills. • Desire to work within a multidisciplinary team. • Computer literacy. • Ability to work internationally.
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