Sanofi Group Clinical Strategy Head Rare Diseases and Rare Blood Disorders in Cambridge, Massachusetts
Clinical Strategy Head Rare Diseases and Rare Blood Disorders
The TA Clinical Strategy Head, Rare Diseases and Rare Blood Disorders Development Therapeutic Area will provide deep therapeutic expertise and direction across the Rare Diseases and Rare Blood Disorders (RD & RBD) development portfolio.The position, which requires expertise in rare diseases, hematology, and gene therapy, is part of the RD & RBD development management team and provides medical and scientific expertise and support to research and development projects in the therapeutic area. Through insights from an extensive external network and deep clinical experience, the position ensures consistent high-quality clinical plans. The position will also establish a consistent standard of evidence generating plans to meet the needs of patients, prescribers, regulators, payers and policy makers throughout all TA development projects. The incumbent will be key to ensuring that the unit is a world leader within RD & RBD development, working in collaboration with highly skilled and experienced experts and leaders.
Manage therapeutic area portfolio strategy and ensure projects remain in alignment with that strategy.
Work above project focused clinical/scientific staff and provide scientific guidance and medical insights where needed for optimal design of studies to meet stakeholder needs and optimize probability of success.
Co-chair of the RD & RBD PRC (Protocol Review Committee).
Be a resource and advisor to the Global Project Heads for the strategic decisions needed in individual projects.
Provide medical and scientific guidance to project clinical leads and clinical research directors. Provide mentoring and coaching to less experienced MDs.
Work closely with the Therapeutic Area Head to define disease area development strategies and the creation of a robust and innovative portfolio and rapid progression of the development pipeline.
Ensure a thorough, integrated review of external opportunities and provide recommendations to Business Development and the development team. In addition, will identify key issues that need to be optimized and provide oversight and feedback for collaborative projects.
Provide a continuum of medical and scientific expertise leadership for the Company from pre-clinical and clinical development through to commercialization and lifecycle management.
Advise on medical activities involved in interactions with regulatory authorities/agencies and key opinion leaders and/or provides leadership and serve as an advisor to the clinical research physicians engaged in these activities.
Ensure that the TA operates to the highest level of medical/clinical evidence.
Ensure rigor of evidence generation strategies to maximize target product profile.
Advise with clinical development teams to build optimal clinical development plans that anticipate and mitigate risks.
MD (ideally MD/PhD) with specialization or industry experience in rare diseases and/or hematology, including gene therapy experience within those areas, with strong business acumen and proven ability to develop and apply clinical development strategy in a global environment.
A high degree of scientific insight into projects combined with medical credibility and negotiation skills.
Track record of KOL engagement, publications, speaking engagements, and advisory board leadership.
Expertise & experience in the development of RD & RBD assets with both internal and external experts and stakeholders.
Engagement in pharmaceutical drug development; basic and or clinical science.
Experience with regulatory and payer interactions.
Substantial history of clinical development leadership, with deep therapeutic expertise and a successful track record in leading transversal projects through development, registration, approval and successful market access.
Comfortable dealing with ambiguity and change.
Trial protocol review and development.
Analytical and synthetic thinking skills.
Open minded, critical thinker.
Solutions provider, converts challenges in opportunities.
Ability to navigate the management matrix; strong people and negotiation skills.
Good motivator and mentor to clinical staff.
A positive, motivational and enthusiastic leader who is driven by the need to ‘make a difference’ to the organization.
Embraces Sanofi’s values, vision and mission.
Strong interpersonal, presentation and negotiation skills across all levels of the organization.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.