Global Medical Evidence Generation Lead - Hemophilia

Job Title: Global Medical Evidence Generation Lead - Hemophilia Portfolio

Location: Cambridge, MA / Morristown, NJ

About the Job

This role reports into the Global Medical Head of Hemophilia; that is part of the Global Rare Disease Medical Team. Our Medical Affairs function serves as a key strategic partner with commercial, regulatory, clinical, HEVA and market access on therapeutic solutions to support patients’ needs.

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Oversee all data generation activities (phase IV interventional and observational studies, RWE studies, ISS and external collaborations) for product(s) in scope in Hemophilia, from the strategy (data gap analysis, study design) to the execution (study enrollment, budget tracking, etc).

• Collaborate with cross functional partners as appropriate

• Support on regulatory submission and interaction with global regulatory agencies

• Support alliance relationship as needed

• Support institutional research relationship as needed

• Lead the execution and support the strategy of global Medical Affairs studies, including the management of the study Steering Committee, development of the study results analysis and dissemination plan (primary and secondary results), collaboration with the global operational and local medical teams to support study enrollment

• Provides leadership to the life-cycle management strategy, performs yearly global data gap analysis and identifies needs for high value medical affairs driven studies and other evidence generation related activities, and oversees their management and execution in accordance with established budgets and timelines

• Develops medical strategies to obtain relevant evidence from Investigator Sponsored Studies, including Real World Evidence, consistent with data generation objectives  

• Supports regulatory interactions and respond to request from the global regulatory agencies (FDA, EMA and other agencies) as required and appropriate

• He/she will aim to manage programs in an innovative, digital, and effective way

• Supports sharing of best practices between priority countries and others

• Ensures a patient-centric approach to the development and execution of projects under his/her accountability  

• Adheres strictly to compliance rules, regulatory, access and ethical requirements

About You

Experience:

• MD, PhD, or PharmD preferred, with expertise in Rare Hematologic Disorders

• Minimum 5 years’ experience in industry Medical or R&D, with solid track record of achievement in Medical Affairs in the biotech/pharma industry.

• Suitable prior experience with global medical or clinical studies; experience within hemophilia or rare diseases would be advantageous.

• Experience working in an international multi-country setting is definitely a plus.

Soft skills:

• Strategic thinking: ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities. When under pressure, ability to bring others along to explain how strategic ideas fit into the larger context, and approach challenges thoroughly with a broad view, considering different potential outcomes.

• Result orientation: driven to develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions. Comfortable with ambiguity and ability to adapt with agility, take calculated risks and anticipate pot