Sepracor
-
Marlborough,
MA
The primary responsibilities of this position include the Strategic Planning and Clinical Support for Development Programs and Medical Affairs activities in Neurology.
Essential Functions Development of clinical research programs in a variety of neurological indications from Phase I to IV, leading to submission, regulatory approval and commercial success in the US and rest of the world.
Medical Director accountable for the design and medical supervision of clinical trials supporting the research program strategy including preparation and review of written documents: Clinical Trial Protocols, Case Report Forms, Clinical Study Reports, and providing medical leadership to the study operations teams.
Close collaboration with Drug Safety, Regulatory, Clinical Operations, New Products Planning, Marketing, Medical Communications, Discovery, Early Drug Development and other disciplines within Sepracor.
Preparation of documents for submission to regulatory authorities (Meeting Packages, Investigational Drug Applications [IND], NDAs, clinical components of other regulatory correspondence)
Participation as clinical expert in the evaluation of early discovery compounds or early stage external assets for their potential to be successful candidates for development
Clinical support for the evaluation of potential early and late stage licensing opportunities.
Interactions with key opinion leaders, and the ability to leverage these contacts to support organizational goals.
Minimum education requirements MD
Experience required 3 - 5 Years
Knowledge & skills (general and technical) Education
Physician with Board Certification in Neurology and at least 3-5 years of pharmaceutical industry experience. Level of experience will determine initial level of responsibility.
Experience
A proven track record of academic achievement and successful involvement in CNS research. Thorough and up-to-date knowledge of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape. Experience with working in clinical project teams, especially protocol development and trial initiation. Furthermore, the candidate must show that he/she is able to analyze and synthesize clinical data and has a thorough understanding of the requirements of the regulatory process. Specific experience in epilepsy, pain and/or cognition is desirable.
Complexity
Ability to manage a constant stream of complex pieces of information with an ability come to the essence and prioritize quickly. The team environment at Sepracor requires a high level of communication skills and the ability to engage constructively in interdependent decision-making.
Personal Contacts
Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team. The position requires effective, fact-based interaction with internal and external scientists and key opinion leaders.
Other requirements (licenses, certifications, specialized training, physical or mental abilities required) Additional Requirements
Hours may include meetings scheduled outside of normal working hours. Demands during peak times may require work hours outside of normal working hours. Some travel will be required, estimated to be 20% of time. This will include presentation of clinical research data at national and international conferences, advisory boards, interaction with key opinion leaders, and diligence evaluations of potential in-licensing and/or partnering candidates.
Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters while working at Sepracor is considered confidential.
Compliance Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sepracor are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Marlborough, MA
Marlborough, Massachusetts
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