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Medical Director - US Medical Affairs Neuromuscular Disorders - ALS

Company: Biogen
Location: Weston
Posted on: September 11, 2020

Job Description:

Company Description

Job Description

As a key member of the US Medical Neuromuscular team, the Medical Director ALS is responsible for supporting the development and implementation of the US medical strategy for Biogen’s ALS program, initially focusing on a phase III asset and will be instrumental in preparing for launch.

Serve as the US Medical contact for global Medical, Clinical development and R&D teams to ensure contribution of US Medical perspective to global strategy/tactics as well as alignment

Serve as the US Medical contact for key functions/stakeholders on the US affiliate level (e.g. Field Medical Teams (MSLs/MVLs), Commercial, Market Access, Legal/Compliance)

Develop/implement strategy for US-relevant data generation and lead specific data generation projects to address identified medical/scientific data gaps in close collaboration and alignment with global Medical, Clinical Development,  Real World Evidence Generation teams and R&D

Serve as US Medical expert for US-focused collaborative research projects and provide US-perspective for data generation activities on the global level

Provide medical expertise to cross-functional teams. As a content expert, develop and review medical materials like e.g. training materials for field medical teams, materials for KME engagements (proactive/reactive)

Provide medical oversight for promotional materials on the commercial Promotional Review Committee for contracted vendor reviewer as applicable in the process/in case of escalation

Contribute to the development/adaptation of medical materials (e.g. presentations, trainings, medical briefs and talking points) for the US Medical team according to DSMR requirements and manage submission process.

Engage, oversee and manage vendors involved in medical affairs activities and manage budget for assigned projects

Provide medical expertise for the content development for advisory board meetings, roundtables, medical forum events or other medical affairs activities; present data at US Medical affairs events, incl. advisory boards and trainings as well as congresses/medical education events

Represent US Medical Affairs at other cross-functional meetings as needed

Collaborate with global functions to represent US Medical Affairs perspectives as assigned/delegated

Effectively interact and collaborate at multiple levels in the Biogen organization, including effective cross-functional interface within US Medical Affairs, Global Medical Affairs, Market access, Regulatory Affairs, Legal/Compliance, Government Affairs, Patient Advocacy teams

Build and nurture relationships with external stakeholders in the therapeutic area landscape

Serve as representative of Medical department in regulatory interactions, investigators and expert advisory board meetings, external professional societies, seminars, and conventions

#LI-NM1

Qualifications

Minimum of 5 years of pharmaceutical industry experience is required

Extensive Neurology/Neuromuscular experience in Amyotrophic Lateral Sclerosis (ALS) required (experience as ALS clinician is preferred)

Established network of relationships in ALS

Experience in Medical Affairs or related industry function (e.g. HEORE, Real World evidence data generation) required

Experience in area of genetic testing/counseling as well as managing Expanded Access Programs is a plus

Ability to understand the evolving market access and reimbursement landscape and the role of Medical strategies in the context of Biogen’s business needs

Ability to work with minimal oversight yet to engage in collaborative decision making, providing transparency and ensuring alignment with key stakeholders as well as ability to complete tasks in a timely fashion, and function in a rapid-paced environment

Background in ethical evaluation of clinical research projects, and proven ability to conduct medical and scientific analysis and scientifically founded decision-making

Ability to effectively operate in a highly matrixed organization

Strong interpersonal skills and project management skills

Ability to take initiative and solve complex and challenging problems

Understanding of US regulatory environment and pharmaceutical industry regulations

Experience in Neurology/Neuromuscular Diseases (specifically ALS) required

Education:

MD, PhD, PharmD or other advanced degree in the life sciences is required

Additional Information

As a key member of the US Medical Neuromuscular team, the Medical Director ALS is responsible for supporting the development and implementation of the US medical strategy for Biogen’s ALS program, initially focusing on a phase III asset and will be instrumental in preparing for launch.

Keywords: Biogen, Fort Lauderdale , Medical Director - US Medical Affairs Neuromuscular Disorders - ALS, Other , Weston, Florida

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