Medical Director - Clinical Development
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Ardsley, NY, United States
The Medical Director - Clinical Development is responsible for leading the development and life cycle management for assigned products.
The Medical Director - Clinical Development is responsible for leading the development and life cycle management for assigned products. This individual requires leadership skills necessary for the strategy, development, management and implementation of Phase II-IV studies for assigned products, both within approved indication(s) and as pilot studies for new indications. The Medical Director - CD is extensively involved with development colleagues, regulatory affairs, and the commercial organization.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Serves as medical team leader.
- Acts as a team leader for study design, implementation and timely completion of assigned clinical studies and helps address post-marketing research needs for Phase II-IV studies.
- Provides direction, training and follow-up to ensure compliance with department and corporate policies and procedures.
- Manages aggressive timelines; integrate scientific rigor, medical need and commercial value into clinical plans culminating in successful registration and marketing.
- Participates in strategic oversight and leadership for clinical development from proof of concept to NDA filing.
- Attends scientific meetings and fosters and develops strong relationships with investigators.
- Contributes to the development of new indications for existing products.
- Assists with the development and implementation of publication strategies for products in development.
- Identifies and implements high value strategies for product life cycle development.
- Participates in multidisciplinary teams including alliance partners for strategic and tactical planning of in-line and products in development.
Education and Experience:
- An MD is required.
- Strong neuroscience background is required.
- A minimum of three years progressive experience in pharmaceutical, biopharmaceutical or biotechnology drug development is required.
- Excellent understanding of the interdependencies of the various preclinical, clinical, regulatory and commercial disciplines is required.
- Board certification/Board eligible in Neurology or Internal Medicine is preferred.
- Prior development experience leading to an NDA or BLA submission is preferred
- The Medical Director leads assigned cross-functional teams
- A proven ability to build productive relationships and teams both internally and externally and the ability to develop high potential subordinates into leadership roles is required
- Prior experience in managing clinical trial conduct for neurological disorders is preferred
- Strong working knowledge of Good Clinical Practice, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities is preferred.
- Ability to facilitate and merge science into commercially viable products.
- Must be proficient in MS Office Suite
Certificates, Licenses, Registrations: Board Certified or Board Eligible
Other Skills and Abilities:
- Strong leadership and organizational skills.
- Excellent oral and written communication skills.
- Experience leading large projects/organizations.
- Energetic, flexible, enthusiastic and highly motivated.
- Able to work effectively with outside service providers.
- Ability to maintain high level of ethical and compliancy standards.
- Demonstrated ability to stay abreast of trends and new information in the profession
- Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires travel (including overnight stays); average travel for this position is 25-30% with some variation based upon the demands of business imperatives. Travel is both domestic and international for internal and external business meetings.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.