The position of AMD/MD, Clinical Development sits within the Pain, Neuromuscular and Rare Disease Area Unit of Late Stage Clinical Development. The new AMD/D will support late stage clinical development programs for Pain. The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple studies. Activities include direct responsibility for advancing high priority clinical programs through clinical study design and execution, medical oversight and medical / clinical development leadership on study teams, development of biomarker strategies, as well as interpretation of data from key clinical studies. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.
The Associate Medical Director / Medical Director has the following responsibilities: Will report to a more senior member of the pain clinical team who has direct responsibility for the overall research strategy and clinical and scientific development activities.
Provide medical leadership for programs that integrate the individual's knowledge in in basic science, drug development, and medical practice with input from the medical community around the world.
May serve on one or more study management teams as a clinical development functional area leader, participating in all aspects of trial execution as required, including presenting at clinical study investigator meetings, monitoring and reviewing incoming data, engaging with study physicians, reviewing final data outputs and other activities as needed
Provide ongoing medical expertise and medical oversight of clinical trials, including eligibility evaluation and toxicity management, in conjunction with external and internal partners
Will support conceptualization and development of clinical trials in conjunction with multiple functions, including development from inception of trials in new indications
Will be part of a team responsible for authoring a variety of trial related documents (eg, investigator brochures, responses to regulatory authorities and institutional review boards, clinical study reports)
Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice
May interface with key medical experts and represent the team at medical congresses and conferences
Provide medical content expertise to internal and external stakeholders
Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework in support of executing the Clinical Development Plan (CDP)
Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
Contribute to the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
May support other therapeutic areas in late stage clinical development as business needs require
Biogen is excited to add depth to their Pain Clinical Development team. The ideal candidate will have the following mix of professional and personal characteristics:
Three (3) to five (5) years of experience in clinical and/or translational research with a proven record of achievement on independent research projects or record of achievement in a relevant practice area. Pharmaceutical industry experience and experience with pain trials is a plus.
Ability to think strategically, focusing on the long-range vision and needs of multiple key stakeholders (i.e. patient, different functions, company, neuromuscular space)
Understand and able to put together and present analyses of data.
Ability to compile and present development plans, study designs, analyses of data in forums consisting of individuals representing a variety of functions (eg, both with and without scientific backgrounds)
Excellent communication skills (verbal and written), presentation skills and organizational skills
Ability to represent the department on project teams, committees and at external meetings
Able to work collaboratively in a multi-disciplinary team setting and employ a team approach to decision-making
Ability to partner, influence and inspire others
Ability to balance multiple competing demands and meet aggressive timelines
Scrupulous attention to detail, clear ability to establish and maintain rapid timelines, and persistent commitment to ensuring a high level of quality.
Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20%-30% potential travel).
MD, PhD, or Pharm D degree required; training in a relevant specialty (pain management, anesthesiology, neurology, internal medicine, physiatry) and/or clinical or research experience in the field of pain or neuroscience is a plus