Alexion Pharmaceuticals Sr Director, GMA TA Lead in Boston, Massachusetts
The Medical Director will provide support for strategic planning and leadership in an identified therapeutic throughout the America’s (US, LATAM and Canada) region. Responsible for providing scientific and medical support with an in-depth understanding of the medical landscape. Support the development and implementation of long-term strategy, practices and infrastructure within the America’s region aligning with overall Alexion strategy and effective cross-functional collaboration. Support the Alexion Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care.
Develop and implement global medical (TA) strategy and plan for GMA activities (pre-launch and post -launch as applicable) for the specified therapeutic area by providing medical leadership, insight and strategy to TA global medical affairs team across functions and countries globally. Responsible 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
Development and execution of major registration LCM program and geographically expansion strategy
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 including the review of the Final Report
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
Serves as the medical expert and resource within ALXN in support of the therapeutic area. Responsible 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 Alexion personnel.
Medical affairs review of field medical tools, internal commercial training material. - Pending MLR Workstream recommendations
Independent review of Medical Grant requests including CME, symposia 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. Responsible 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
Responsible for the Global and Country Quarterly Management Review and will be consulted on defining Country-Specific Medical Plan.
Experience in Medical Affairs function
Excellent communication skills both written and verbal.
Regulatory and compliance experience in 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 partnerships cross-functionally
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%
Fluency in Spanish or Portugese a plus
Must have a PhD, Pharm D or MD level degree or equivalent
1-4 years + experience in medical affairs organization ( med info, grant processing, field MSL team, KOL management, scientific communications)
Experience leading cross-functional teams
Experience managing people
Experience in the Pharmaceutical or biotechnology industry
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexion.com.
Alexion is an Equal Opportunity /Affirmative action employer