Senior Medical Director, Life Cycle Management The Head of Life Cycle Management (LCM), Global Medical Affairs _Cambridge, MA
is a high visibility, strategic and operational leadership position reporting to Head MS Global Medical Affairs. This is an exciting opportunity to work in a patient-centric, high performance culture. The Head of Life Cycle Management, Global Medical Affairs will be a member of the MS Global Medical Affairs team, providing input into novel life cycle management opportunities for products in Phase IV and the commercialized portfolio to ultimately improve therapeutic and compliance benefits to MS patients while expanding the development pipeline. The Head of LCM has a crucial role in the development of the yearly Global Medical Affairs Plan, making sure the LCM strategy is aligned with the identified critical success factors. He/she will work in a matrix participating as a member of various Medical Affairs, Clinical Sciences & Operations (CSO), and cross-functional teams and committees to further strengthen the Ph. III b and IV study development of the MS Franchise. Partnering with and providing input to Product Lead(s) and Launch/Commercial Team(s) to define global product launch and life cycle management strategy to impact the achievement of objectives and maximize the value of each product in the franchise is a critical component of this role. The Head of LCM will partner with Clinical Sciences & Operations (CSO) teams while being responsible for coordinating, overseeing, and providing guidance to the MA teams throughout the organization to guarantee seamless and timely execution of the Ph. III b/ Ph. IV program of Genzyme sponsored studies (GSS). This will include managing a team of professionals (MDs, PhDs, project managers) driving the LCM working group across the organization for our current franchise and becoming involved in new programs as they reach Ph. III to strengthen the pre-launch efforts. Support the successful launch and life-cycle management of Genzyme’s marketed product portfolio through innovative thinking and approaches in all areas including Genzyme sponsored studies (GSS) as well as independent research projects to generate data on drug MoA, long term benefit, long term safety, and patient reported outcomes, in close alignment with the Global Medical Affairs Plan. The Head of Life Cycle Management co-chairs the Scientific Review Committee for both Genzyme and Investigator’s initiative studies, coordinates synopsis development for the GSS, provides input into the yearly defined ISS strategies for each of the MS drugs, and coordinates the ISS monthly updates. The exceptional leader that we seek will be responsible to: •Provide leadership to Ph. IV programs to define life-cycle management strategy identify needs for high value post-marketing clinical trials and registries and oversee their management and execution.
•Develop medical strategies to obtain relevant data evidence from company and Investigator Sponsored Studies (ISS), including Real World Evidence, consistent with strategic objectives for each product. Ensure that appropriate processes are in place for review, approval, management and support of studies while maintaining investigator independence.
•Communicate product life-cycle management strategy to regional/local Medical Affairs experts and product managers. Ensure that studies planned by regional and local affiliates fit into the global product strategy.
•Ensure and oversee the planning, execution and reporting of clinical studies as defined in the Global Medical Affairs plan and in accordance with established budgets and timelines. Monitor performance of phase IV activities (e.g. value creation) from conception through publication of clinical study results and take corrective actions or escalate issues as appropriate. Contribute to continuous improvement of phase IV study related processes and best practices.
•Lead/co-chair team(s) responsible for peri-/post-approval data analyses and evaluations to ensure appropriate prioritization of resources and effort towards generation of medical-scientific results in support of key publications, health authority and market access requests, as needed.
•Establish a strong network within the MA organization (Global, Regional and local) and also with other stakeholders namely the R&D, the Clinical Sciences & Operations (CSO), and Pharmacovigilance teams. •The financial management and reporting requirements of LCM studies and ISSs with accurate and timely data and assumptions to support budgeting, forecasting and long range planning for the business unit. •Represent the Global MS Medical Affairs team at medical meetings, advisory boards, outreach meetings at key institutions, and in interactions with KOLs. Basic Qualifications
•Either advanced degree (e.g. MPH, PhD or M.D.) combined with industry experience working in related areas (e.g. LCM, Clinical Development, Project Management, etc.), preferably related to MS. Well established leadership and management skills in attracting, mentoring and retaining high performing medical affairs professionals.
•Experience in managing clinical trials in a pharmaceutical or equivalent environment is strongly desired. Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management, regulatory requirements and compliance for conduct of clinical research essential.
•Demonstrated ability to work effectively in a matrix environment.
•Excellent skills working cross functionally, specifically partnering with all the internal and external stakeholders.
•High energy and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives.
•Comfort operating in a consensus building role but also able to make critical decisions and drive these decisions through the organization.