The Associate Medical Director is responsible for working with Medical Writing, Clinical Operations, Project Management and R& D to design, prepare and execute clinical protocols for early phase drug development candidates in the Acorda pipeline. This individual collaborates extensively with Clinical colleagues, regulatory affairs, and the commercial organization. The Associate Medical Director leads the development, management and implementation of Phase I-II studies of new biologics and small molecule drugs. This individual assists with the creation of a seamless transition of products from Early to Late Development. PLEASE REFER TO JOB CODE 1113 WHEN APPLYING FOR THIS POSITION
*Essential Duties and Responsibilities include the following. Other duties may be assigned.:
• Serves as medical team leader and oversees clinical trials to ensure compliance and safety.
• Participates in strategic oversight and leadership for clinical development First- In- Humans to Proof-Of-Concept.
• Attends scientific meetings and fosters and develops strong relationships with investigators.
• Manages aggressive timelines; integrate scientific rigor, medical need and commercial value into clinical plans culminating in successful registration and marketing.
• Assists with development and implementation of publication strategies for products in development.
• Participates in multidisciplinary teams including alliance partners for strategic and tactical planning of products in development.
• Acts as the team leader for study design, implementation and timely completion of Phase I and II studies.
• Provides direction, training and follow-up to ensure compliance with department and corporate policies and procedures.
Education and/or Experience:
• An MD is required with board certification or eligibility in a primary care specialty and comfort in handling medical issues encountered in Ph 1 trials in various patient populations
• Minimum of three to five years of experience in the conduct of Phase 1 trials.
• Prior experience in managing clinical trial conduct for neurological disorders is required.
• Prior experience with Pharmaceutical, Biopharmaceutical or Biotechnology drug development is preferred.
Supervisory Responsibilities: :
• Working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities.
• Excellent understanding of the interdependencies of various preclinical, clinical, regulatory and commercial disciplines is required.
• Prior experience facilitating and merging strong science into commercially viable products.
• Must be proficient in MS Office Suite.
Other Skills and Abilities::
• Excellent writing, communication and presentation skills.
• Demonstrated leadership and project management skills.
• Excellent organizational skills.
• Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines.
• 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.
• Proven ability to build productive relationships and teams internally and externally and the ability to develop high potential subordinates into leadership roles are critical.
Location: Corporate Office:
This position requires the ability to work on-site five days per week in the Corporate Office located in Ardsley, NY.
Physical Demands: :
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% with some variation based upon the demands of the business imperatives. Travel is both domestic and international and is for scientific and medical conferences as well as meetings with investigators and KOL's.
Work Environment: :
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.
Acorda Therapeutics - 10 months ago