Sepracor
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Marlborough,
MA
Clinical direction of interdisciplinary drug development team responsible for the design, implementation, and completion of a clinical research program for drug(s) or biologic(s), leading to the submission and successful approval of a New Drug Application (NDA) to the FDA. Major Responsibilities will include:
• Strategic Planning of Drug Development
• Design and Conduct of Clinical Trials
• Preparation and review of written documents: Clincal Trial Protocols, Case Report Form, Clincal Study Reports
• Interactions with key individuals from other disciplines on the drug development project team
• 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 successfully candidates for pharmacologic development
• Clinical oversight and direction of post-marketing FDA mandated trials
Essential Functions • Ongoing thorough and up-to-date knowledge of therapeutic areas of assets for development, including trends, advances, understanding of mechanism of acting and efficacy of therapies currently available, and competitive clinical landscape
• Close collaboration with Drug Safety, Regulatory, New Products Planning and Discovery and other disciplines within Sepracor.
• Interaction with Medical Affairs and Commercial group to achieve optimal target product profile for drugs in development and to achieve optimal commercialization of approved drugs.
Minimum education requirements MD
Experience required 10+ Years
Knowledge & skills (general and technical) Background in clinical research including, ideally to include randomized clinical trials that evaluate drug or biological therapies. Prior experience in clinical trials in pharmaceutical industry or a focus on clinical research in academic medicine is desirable. Knowledge of FDA-CDER regulations regarding evaluation and approval of pharmaceuticals (required for Director).- An understanding of US pharmaceutical safety reporting and surveillance (required for Director). Individuals with less experience may be considered for an Associate Director level role.
Other requirements (licenses, certifications, specialized training, physical or mental abilities required) MD or DO from an accredited Medical School
US Board Certification in Internal Medicine or Pediatrics
Subspecialty Training and Board Certification in Medical Subspecialty of Allergy/ Immunology or
Pulmonary Disease desirable.
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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