Executive Director, Late Phase Medical Lead
The Executive Director , will provide global support for strategic planning and leadership in our metabolics program for Rare GI. He/She will be responsible for providing strong scientific and medical support with an in-depth understanding of the Metabolics medical landscape, particularly in the designated therapeutic areas. He/She will also support the development and implementation of the short and long-term strategy, practices and infrastructure for Global Activities, aligning with overall medical affairs strategy and effective cross-functional collaboration, namely on the development of phase IIIB/IV research, Advise seeking activities, Patient Engagement, Materials, etc. Support the Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care.
Job Duties & Responsibilities
Develop and implement global medical strategy and plan for GMA activities (pre-launch and post -launch as applicable) for the Metabolics by providing medical leadership, insight and strategy to the global medical affairs team across functions and countries globally. Responsible for the following:
- Develop in-year global medical strategy, Implementation and budget plan for global initiatives
- Lead on the situational assessment and the global product strategy development including harmonization of activities involving KOLs.
- 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 Metabolics programs in close collaboration with relevant functions
- Provide medical review and ensure alignment with Metabolics 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 Metabolics 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.
- Lead content development and presentation for external medical education programs, and other Global Medical initiatives
- Develop, conduct, or participate in therapeutic training programs for personnel.
- Medical affairs review materials
- 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 and value 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 Metabolics 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.
- Disease and Product Expertise (preferably with background on Neurology, Endocrinology, Hepatology or Internal Medicine)
- Experience leading Medical Affairs function
- Proficient in Medical Governance and operations, with extensive regulatory and compliance experience leading a Medical Affairs organization
- 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
- 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
- Fluent in English
- Travel required up to 25% to 35%
- Scientific and technical acumen in Neurology, Hepatology, Gastrenterology, Lipidology and/or Bone Metabolism
- Fluency in Spanish or Portuguese is a plus
- Health Outcomes Research/Reimbursement Experience
- Regulatory Affairs
- Clinical Development Experience
- Must have a MD, PhD or PharmD level degree or equivalent
- 3 years + experience in medical affairs/R&D organization ( Development, Phase IIIB/IV, med info, grant processing, ISR review, field Experience, Global KOL management, scientific communications & publications)
- Experience leading cross-functional teams
- Experience managing people
- Experience in the Pharmaceutical or biotechnology industry
please email CV and cover letter to firstname.lastname@example.org for consideration