Medical Director, SMA & ALS - US Medical Affairs

Role Summary

The Medical Director Spinal Muscular Atrophy (SMA) role is a part of North America (US) Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. As a key member of the US Rare Disease Medical Director office team reporting to the USM Rare Disease Head, the Medical Director SMA and ALS (Amyotrophic Lateral Sclerosis) is the medically accountable lead for supporting the development and implementation of the US Medical Strategy for Biogen’s SMA and ALS therapeutic area commercialized products, pipeline, and related assets.

Responsibilities

• Lead the long-range planning, development and execution of the US medical strategy, tactics, and budget for SMA (nusinersen), and ALS (tofersen) in alignment with Global strategy & US budgetary expectations.
• Serve as the US Medical expert within SMA and ALS for collaborative research projects and provide medical oversight for commercial promotional materials.
• Serve as the US Medical contact for key functions/stakeholders on the US affiliate level (e.g., Field Medical Teams (MSLs, Medical Account Directors), Commercial, Market Access, Legal/Compliance, Epidemiology, Pharmacovigilance), effectively interacting and collaborating at multiple levels.
• Develop the US-relevant data generation strategy and lead specific data generation projects to address identified medical/scientific data gaps in close collaboration and alignment with US SMA and ALS clinical experts, global Medical, Clinical Development, Real World Evidence Generation teams and R&D (Research & Development).
• 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 processes.
• Present data at US Medical affairs events, including advisory boards and trainings as well as congresses & medical education events. Build and nurture relationships with external stakeholders (including HCPs, healthcare institutions and advocacy groups) in the Biogen Rare Disease therapeutic landscape.
• Create positive team climate in alignment with Biogen‚Äôs culture. Ensure individuals within the Rare Disease Team are effectively assessed and coached with talent development plans in place that will be executed as appropriate.

Qualifications

• Required Skills:
  • MD, PhD, PharmD, DNP, or comparable advanced degree
  • Minimum of 5 years of pharmaceutical industry experience, preferably with prior work in Headquarters-based Medical Affairs role or Field Medical based role. Substitution of industry work with relevant clinical practice experience in Rare Disease (preferably SMA and ALS) may be considered.
  • Relevant experience in Rare Disease required
  • Strong working knowledge of US regulations as relevant to Medical Affairs
• Preferred Skills:
  • Experience with medical launch as well as products at various stages of the lifecycle
  • Ability to lead and collaborate with global, regional and/or affiliate medical to ensure regional activities are aligned with global medical strategy and address insights/needs
  • Ability to manage projects and solve complex problems
  • Experience managing and developing a team of Medical Affairs professionals

Skills

• Scientific/clinical expertise in SMA and ALS
• Strategic planning and data generation planning
• Stakeholder management and cross-functional collaboration
• Medical communications and materials development
• Leadership and people development

Education

• MD, PhD, PharmD, DNP, or comparable advanced degree

Additional Requirements

• None listed beyond role qualifications and responsibilities