Associate Director / Head of Medical Research Review

  • Full-time
  • Region: US
  • Department: Medical Affairs

Company Description

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine.

Together, we pioneer. Together, we thrive.

Job Description

About This Role

Under the direction of the Director, Research Process & Infrastructure, Medical Research Operations, the Associate Director / Head of Medical Research Review is responsible for all aspects of the review of post-market medical research proposals. Proposals include company-sponsored and investigator-sponsored studies, and the research may be on Biogen’s marketed products or in our disease areas. This individual will own the research review processes and chair the Biogen Medical Research Review Committee. The job involves interaction and partnership with Global, Regional and Local stakeholders in all Biogen’s therapeutic areas.

What You’ll Do

· Chair the Medical Research Review Committee (MRRC) to facilitate the review of proposals on criteria including scientific rigor, operational feasibility, impact, and diversity & inclusion and advise on final funding decisions

· Review proposal submissions, study protocols, study amendments, and study reports to ensure they meet requirements

· Develop and maintain the relevant standard operating procedure and controlled documents including collaboration with cross-functional partners to develop and/or improve processes and procedures

· Educate stakeholders about the MRRC process, develop and deliver relevant training, and assist internal team members and external investigators with proposal submissions

· Partner with quality functions to support audits, inspections, and CAPA management as needed

Who You Are

You care about medical research and improving patient care through data generation. You have a strong sense of urgency and ability to talk to diverse stakeholders – from investigators to senior colleagues. You understand the importance of optimizing processes for effective decision making and are able to balance general requirements with individual needs.

Qualifications

Required Skills

· Bachelor's degree in a relevant life science or equivalent scientific research training is required. Advanced degree such as MA, PhD, PharmD or MD preferred.

· At least five (5) years of experience in research, preferably in design, conduct, and/or evaluation of clinical studies. Experience in Medical Affairs preferred.

· Ability to operate effectively in a highly matrixed organization with excellent stakeholder management

· Highly organized, with attention to detail, good project management skills, and a sense of urgency

· Ability to take initiative and solve complex and challenging problems

· Excellent communication, leadership, and presentation skills

Preferred Skills

  • Knowledge of relevant therapeutic areas (CNS generally, neuromuscular disease, neurodegeneration, neuropsychiatry, specialized immunology)

Additional Information

All your information will be kept confidential according to EEO guidelines.

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