Alexion Pharmaceuticals Executive Director, Global Medicine Team Leader in Boston, Massachusetts
The ED, GMTL is responsible for providing strategic direction and leading the global drug development one or more assets that have multiple indications in development.
As the accountable program(s) owner, the Global Medicine Team Leader (GMTL), leads and chairs the Global Medicine Team (GMT), which determines the overall strategy for the asset across indications and oversees the Global Program Teams. The GPTs are responsible for leading the creation of an integrated development plan for each indication and overseeing program execution. , The GMTL is the “one voice” for the GMT up the line (R&D Leadership, Development Steering Committee and Executive Steering Committee), and is the principal liaison and partner to other groups. The GMTL’s role is one of leadership, being proactive and interactive, and emphasizing partnership with all GPTLs and GMT/GPT members and other stakeholders and consultants both within and outside R&D. The GMTL should stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with the GMT. The GMTL has negotiation and persuasion skills necessary to ensure success of the program and sets goals for the GDT and specific program-related goals for the Core Team members.
The GMTL is accountable for:
Program ownership with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals
Responsible for developing the overall asset strategy, including indication sequencing, overall regulatory and CMC strategy to support all of the indications under development
Provides strategic direction and leadership to the GPTs to ensure clear goal setting and robust development plans for effective and efficient development of the asset overall.
Ensures that the GMT and GPTs implements plans and adheres to key development milestones for assigned projects.
Contributes to objective setting and appraisal of core team members for program related activities
Keeps senior management informed
Ensures high performance team effectiveness
Total leadership experience including line/project management, multidisciplinary program management experience, which includes leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings.
Minimum of ten (10) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency.
Demonstrated experience leading drug development projects and activities in a matrixed, global organization.
A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.
A thorough understanding of how to influence local and global regulatory, scientific and commercial environments.
Ability to assimilate data, recognize key variables and analyze complex situations to substantiate strategic recommendations.
Has a realistic expectation of the business, one’s self and others.
A style which builds alliance within the organization, locally/globally, and/or corporate collaborators.
Does not confuse effort for results.
Tenacity to weather short-term setbacks for long-term advantages.
Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
Solid understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings – IND/IMPD, BLA/NDA/MAA
Has experience leading preparation of PMDA/EMA/FDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-BLA/NDA, Advisory Committees, focusing on the key strategic issues.
Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) – what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.
Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.
- Advanced life-science degree (MD, PhD or PharmD) is preferable with a specialty in the assigned therapeutic area, or equivalent experience with global development required.
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 global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also 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) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
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.