SENIOR Medical DIRECTOR, clinical scienCE

Our Client is a product-focused cardiovascular drug development company with two late-stage clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, an engineered analog of recombinant human activated Protein C, and a pre-clinical program directed at improving cardiovascular function.

Position Summary

The incumbent will be responsible for the design, oversight and development of clinical development plans including component studies. This person will provide medical expertise and guidance in clinical and non-clinical plans including strategic direction, planning, execution, and interpretation of clinical trials/research.

Key Responsibilities include but are not limited to

· Oversees the direction, planning, execution and interpretation of clinical trials/research and data collection activities.

· Responsible for research and documentation of products from development through government approval.

· Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports.

· Manages the tracking of research and development in relevant therapeutic fields with respect to competitive products and programs, trial designs, clinical practices, regulatory developments and developments in understanding of mechanistic targets.

· Responsible for clinical protocols, data collection systems and final reports in compliance with appropriate regulatory and medical standards

· Responsible for directing human clinical trials, phases I – IV, for company products under development.

· Responsibilities also include safety responsibilities monitoring.

· Responsible for medical and scientific content for regulatory submissions.

· May act as consultant/liaison with other corporations when working under licensing agreements.

· Selects, develops and evaluates personnel to ensure the efficient operation of the function

· Researches and evaluates alternative indications for existing programs/products

· Provides support for due diligence activities for partnering of company’s programs and for evaluation of in-licensing and acquisition possibilities

· Provides scientific support for marketing/commercialization strategy and plans

· Acts as spokesperson for clinical and medical affairs to the FDA and other regulatory agencies.

· Interacts with and coordinates various inside/outside groups to facilitate clinical research.

· Ensures implementation of policies, procedures and quality standards.

Other duties as assigned.

Qualifications and Skills Required

· Must have an M.D., with specialization in cardiology

· Must have minimum 10 years relevant clinical research experience, preferably in the cardiovascular area

· Preferably experience in the area of atrial fibrillation and good understanding of antiarrhythmic drug development

· Must have experience in interacting with regulatory agencies including presentations

· Familiarity with ICH and GCP guidelines

· A good understanding of the clinical research process from design to reporting, attention to detail and a proven track record of problem solving are required.

· Ability to manage multiple tasks with competing priorities.

· Excellent oral and written communication and inter-personal skills.

· Fluency in English