Biosimilars Medical Head/Senior Director - US

    • Weston, MA

Job Description

In line with the Biogen Biosimilar strategy, the Biosimilars Medical Head US will build and establish the Biosimilars US medical organization. He/she will set and provide the strategic direction for Biogen Biosimilars Medical Affairs in the US market for the whole Biosimilar portfolio. He/she will have an overall responsibility for the full scope of the country medical activities, including scientific communication, post marketing observational studies, medical education, medical field coverage, patient support programs, pharmacovigilance, drug safety and medical compliance for all Biosimilar products within the country. The candidate ensures execution of the strategy and builds and maintains trusted medical/scientific relationships with healthcare stakeholders in the territory of major Biogen biosimilar strategic focus. The Biosimilars Medical Head US will build and recruit a team that will support and enable the US organization for the launch of the Biosimilar products and for the end to end medical activities. The position reports to the Global Head of Medical Biosimilars at Biogen and is restricted to US candidates only with US Medical Affairs experience.  The position is based in Weston, MA.

Building of the US Medical Affairs Organization:

  • Gather the understanding of the medical and scientific needs required for the adoption and the maintenance of the Biosimilar portfolio in the US (anti TNF and ophthalmology)
  • Build the US Biosimilar medical team, define the needed functional and field resources, develop the business plan to justify the resource need and partner with HR during the hiring process
  • Identify top external experts and develop strong peer-to-peer scientific partnerships with them, leading external expert coordination strategies within local/regional/global medical teams
  • Support regulatory strategies for registration of new products by providing local expertise
  • Lead the biosimilar products launch in the US market

Strategic Leadership:

  • Develop the strategy for the US Medical Biosimilars organization, in conjunction with other internal functions
  • Partner with RA in supporting ongoing regulatory strategies for registration of new products and a life cycle management of the commercialized products
  • Lead development of the US medical tactical plan partnering with the other business functions and global team 
  • Provide strategic direction and management of biosimilar patient support programs
  • Provide medical input into regional/global medical strategy leveraging local customer insights
  • Manage team across functions to define, establish and execute a coherent business plan that addresses patient needs
  • Collaborate with the business leads and other functional heads within Global Biosimilar Team to align on strategic priorities
  • Partner and collaborate with other functions to show medical value of approved products relevant to the external stakeholders (payers, HCPs and agencies)
  • Develop and manage budgets for medical activities and provide input into the affiliate budgeting and planning process
  • Facilitate sharing of best practices and knowledge across different internal functional pillars

External Engagements:

  • Build high value-added continuous medical educational programs for external stakeholders
  • Identify top external experts and develop strong peer-to-peer scientific partnerships with them, leading external expert coordination strategies within local/regional/global medical teams
  • Interact and manage relationship with the key medical experts (KMEs) ensuring the flawless scientific interactions
  • Ensure the adequate field presence to enable the content delivery to various external stakeholders and execution of the strategy across the US market 

Tactical Execution:

  • Ensure content development to respond to the market educational needs
  • Developing and executing phase IVs, registries, etc. (master real-life medicine) in accordance with the local regulations and the global data generation strategies
  • Develop and execute the patient support program for different products
  • Accountable for the promotional material review (PRC) 
  • Coordinate medical review of country-specific promotional materials to ensure scientific accuracy when needed and clearly express rationale for any objection and sign-off before release
  • Support and partner with other internal functional in the ensuring the full partnership with payer organizations and delivery of the 

Internal Engagement:

  • Team up with other function in developing the brand plans
  • Provide medical perspective and knowledge to other teams within the Biosimilar team and the US organization as appropriate
  • Ensure sound medical judgments
  • Ensure adequate medical training is developed and provided to the affiliate staff
  • Encourage medical team to identify lifecycle extension opportunities for product based on patient needs
  • Develop and maintain high quality medical team
  • Leverage and capitalize on team/individual strengths
  • Deliver training, skill development and assessment of Medical team members
  • Develop specific and actionable development plans for Medical team members
  • Create a climate in which self-motivated individuals will aspire to higher levels of performance by creating high standards and by rewarding and recognizing exceptional performance
  • Create an environment of trust and delegate responsibility to help individuals grow professionally
  • Provide positive and developmental feedback appropriately
  • Provide clear direction
  • Clearly understand the hiring profile; knowing how to match a candidate’s skills with the Medical roles
  • Help to coordinate resources to maximize productivity
  • Manage performance issues appropriately
  • Regularly measure and document performance
  • Responsible for compensation planning and salary adjustments (merit, promotions, LTI and pay adjustments)
  • Ensure exchange of medical information with other functions as appropriate for medical affairs and act as a role model

Compliance overall:

  • Ensure compliance with external laws and internal regulations regarding the appropriate conduct of the Biosimilars US Medical Affairs activities
  • Supervise and continuously enhances all Biosimilars US Medical Affairs business procedures

Impact:

  • Aligned (global/regional/local and cross-functional) affiliate medical strategies for all products
  • Excellence in service through timely medical input to registration, access and reimbursement dossiers
  • Ensure appropriate participation of local sites in research programs through leading development of an affiliate medical research plan
  • Provide an environment that motivates medical staff by ensuring everyone has appropriate individual goals, sufficient coaching and clear understanding of career options
  • Establish BIIB as the external medical partner of choice for our therapeutic areas in line with the Medical Affairs vision
  • Lead cross-functional collaboration where appropriate for medical affairs
  • Be a meaningful contributor of the US Biosimilars Management team

Decision making:

  • Developing, fine-tuning and applying the Medical Affairs strategy to direct Medical Affairs activities within the US Biosimilars team
  • Finding means to execute the Medical Affairs strategy and to build and maintain scientific relationships with stakeholders in the medical/scientific community
  • Identify means to motivate and develop employees; planning and management of the Medical Affairs team’s personal careers
  • Provide Medical Affairs perspective in the affiliate management team
  • Engage in resolution of the US and Global Medical Affairs issues
  • Regional Director decisions
  • Medical Affairs BU strategy implementation
  • Understanding of the local regulatory and stakeholder environment

#LI-RD3

Qualifications

  • MD and/or a PhD
  • Ideally, a minimum of 10 years’ line management experience
  • Minimum 12 years’ experience within a medical affairs role in the pharmaceutical industry (prior experience in ophthalmology; experience in at least one of the following is a plus: immunology / rheumatology / gastroenterology / dermatology)
  • Knowledge and understanding of disease area, the US healthcare system/market dynamics, regulations, policies and SOPs, health economic techniques and trends
  • Considerable experience in interaction with health authorities and medical plans/insurances
  • Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments
  • Demonstrated ability to build a team and develop a high performing organization
  • Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job-level education
  • Exceptional oral and written communication skills

Additional Information

In line with the Biogen Biosimilar strategy, the Biosimilars Medical Head US will build and establish the Biosimilars US medical organization. He/she will set and provide the strategic direction for Biogen Biosimilars Medical Affairs in the US market for the whole Biosimilar portfolio. He/she will have an overall responsibility for the full scope of the country medical activities, including scientific communication, post marketing observational studies, medical education, medical field coverage, patient support programs, pharmacovigilance, drug safety and medical compliance for all Biosimilar products within the country. The candidate ensures execution of the strategy and builds and maintains trusted medical/scientific relationships with healthcare stakeholders in the territory of major Biogen biosimilar strategic focus. The Biosimilars Medical Head US will build and recruit a team that will support and enable the US organization for the launch of the Biosimilar products and for the end to end medical activities. The position reports to the Global Head of Medical Biosimilars at Biogen and is restricted to US candidates only with US Medical Affairs experience. The position is based in Weston, MA.


Back to top