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Vice President, Global Medical Affairs Leader New Haven United States,  

Alexion (company)

Posted on : 12 June 2017

Project Description

 Position Summary 
The Global Medical Affairs Leader will establish and implement an integrated strategic plan and lead all medical affairs activities globally for our company s Complement franchise, consisting of the PNH and aHUS therapeuitic areas.  Responsible for providing scientific and medical leadership towards establishing an in-depth understanding of the medical landscape in relation to relevant diseases and products, develop and implement long-term strategy, practices and infrastructure globally aligning with overall company  strategy. Lead and develop the respective therapeutic area medical affairs teams and ensure close cross-functional collaboration to ensure achievement of objectives and further the company  Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care.


Principal Responsibilities
Develop and implement global medical (TA) strategies and plans for GMA activities (pre-launch and post -launch as applicable) for the Complement franchise (PNH & aHUS) by providing medical leadership, insight and strategy to TA global medical affairs team across functions and countries globally. Accountable for the following:
  • Lead on the situational assessment and the global product strategy development including harmonization of activities involving KOLs.
  • Develop in-year global medical strategy,  Implementation  and budget plan for global initiatives
  • Provide medical strategic recommendation for in-line life cycle management (LCM) and  late phase pipeline programs
  • Develop Phase 3b/4  and ISR evidence generation strategy for late phase pipeline and in-line TA programs
  • Develop  and oversee clinical study design (non-registration phase IIIb/IV, registries, outcomes research etc.) for late phase pipeline and in-line TA programs in close collaboration with relevant functions
  • Provide medical review and ensure alignment with TA strategy of Investigator sponsored research (ISR) proposals
  • Provide clear strategic guidance to scientific communication, internal medical training, external medical education (CME, Symposia, medical education), Medical info, PEVT teams in developing functional plans supporting global medical strategy
  • Develop medically appropriate commercial strategy/tactic, planning and execution
  • Provide global medical guidance to country medical teams in developing country medical plans aligned with global medical strategy
  • Collaborate with country medical TA lead to ensure local activities are aligned with global medical strategy and that Global Medical is sufficiently aware of country insights and needs. Alignment among Global and Country Medical Plans, adjust if needed.
  • Monitor team performance in terms of goals and delivery of global medical plans
  • Responsible for development and execution of major registration LCM program and geographically expansion strategy


Serves as the medical expert and resource within ALXN in support of the therapeutic area and accountable for the following:
  • Lead content development and presentation for external medical education programs,  and other Global Medical initiatives
  • Develop, conduct, or participate in therapeutic training programs for company  personnel.
  • Medical affairs review of field medical tools, internal commercial training material. - Pending MLR Work stream recommendations
  • Independent review of Medical Grant requests including CME, symposium and others.
  • Medical affairs review of post approval regulatory responses and annual safety reports
  • Medical affairs review of reimbursement dossiers
  • Medical affairs review of congress abstracts and publications


Establishes strategic partnerships with centers of excellence and KOLs in areas of scientific interest and serves as  conduit for flow of information both out to the medical community and into the company. Accountable for the following:
  • Development and execution of Global KOL medical engagement strategy
  • Provide TA KOL engagement strategy and guidance to country medical teams in developing country KOL engagement plans
  • Establish and/or enhance partnerships with key academic institutions and develop relationships with global key thought leaders
  • Planning, designing and managing global medical Advisory Boards  and gather insight from regional/local medical Advisory Boards


Accountable for:
  • Global and Country Quarterly Management Review and consulted on the defining the Country-specific Medical Plan.
  • Clearly communicate Medical Affairs program information in a variety of settings
  • Provide strategic input into program prioritization and cross-functional coordination
  • Manage the TA Medical Tactical Budget
  • Focus project team plans on optimizing value, time, resources, risks and productivity
  • Clearly communicate Medical Affairs program information in a variety of settings
  • Provide strategic input into program prioritization and cross-functional coordination


  • Experience leading Medical Affairs function
  • Strong people management and leadership skills acquired in a multicultural environment
  • Excellent communication skills both written and verbal. 
  • Ability to lead and motivate a  team, both internally and remotely
  • Extensive regulatory and compliance experience leading a  Medical Affairs organization
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and project leader
  • Previous Clinical Operations experience (design and implementation of clinical trials)
  • Proven ability to manage budget and resources
  • Strong business acumen
  • Ability to build partnership access between HQ and affiliates
  • Flexibility and ability to adapt to changing conditions
  • Excellent problem solving, organizational, and negotiating skills
  • Must demonstrate an energy and enthusiasm which brings a positive approach to all challenges Sense of ethics and responsibility
  • Travel required up to 25%


  • Must have a PhD, Pharm D - MD preferred  
  • 10 years + experience in medical affairs organization
  • 7+ years + experience leading cross-functional teams
  • 10 years + experience managing people in a global environment
  • 10 years + experience in the Pharmaceutical or biotechnology industry

 About Us: 
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.  
  • As the global leader in complement inhibition, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.  
  • Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders 
  •  In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.


New Haven US

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