Associate Medical Director - Clinical Research

Opus Scientific has a great opportunity at a well established and progressive biotechnology company for an Associate Medical Director -  Clinical Research.  Lead the development, management and implementation of Phase I-II studies of new biologics and small molecular drugs as well as assist with the creation of a seamless transition of products from early to late development.

 

Responsibilities:

• Serve as medical team leader and oversees clinical trials to ensure compliance and safety.
• Participate in strategic oversight and leadership for clinical development First- In- Humans to Proof-Of-Concept.
• Attend scientific meetings and fosters and develops strong relationships with investigators.
• Manage aggressive timelines; integrate scientific rigor, medical need and commercial value into clinical plans culminating in successful registration and marketing.
• Assist with development and implementation of publication strategies for products in development.
• Participate in multidisciplinary teams including alliance partners for strategic and tactical planning of products in development.
• Act as the team leader for study design, implementation and timely completion of Phase I and II studies.
• Provide direction, training and follow-up to ensure compliance with department and corporate policies and procedures.

 

Qualifications:

• 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.
• 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.
• Proficient in MS Office Suite.
• 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.
• Able 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.
• Able to travel on average 25% (including overnight stays). Travel is both  domestic and international for scientific and medical conferences as well as to meetings.

 

Salary:   TBD

 

If this opportunity meets your career goals and you possess the prerequisite skills and experience, submit your resume to [Click Here to Email Your Resumé] 

Subject line:  Associate Medical Director

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