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Head of Rare Diagnostics and Scientific Affairs

Cambridge, Massachusetts Permanent Date de publication Oct. 28, 2024
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About the Job

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.

Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees.  With a focus on rare diseases, we are dedicated to making a positive impact on the lives of the patients and families we serve.  Our portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi Global Business Unit, Specialty Care benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Sanofi prizes for Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants are welcome to apply and will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.

The Head of Rare Diagnostics is a key member of the Rare Global Medical Affairs leadership team in the Rare Disease franchise. The candidate will oversee a team of scientific subject matter experts in Lysosomal storage disorders; hemophilia, immune-mediated rare blood disorders and other rate conditions. The team expertise includes the scientific and operational aspects of setting up and overseeing company sponsored testing programs; biomarkers and monitoring programs; the creation and implementation of diagnostic algorithms, supporting new born (NBS) screening policies and NBS evidence generation activities; the harmonization of company sponsored testing across countries; and ensuring best practice dissemination.

The candidate will serve as a thought leader for cross-functional team on diagnostic device development strategy from clinical development through commercialization phases of product lifecycle. The candidate will also be responsible for development and execution of FIND strategy across rare disease portfolio and will support development of medical and commercial plans, participate in global team meetings, and scientific review meetings representing scientific affairs.

The objective of these activities is to improve the health outcomes of patients with rare diseases, specifically by improving access to diagnostics and educating the community on appropriate diagnosis strategies.

He/she will work closely with the leadership of Rare Disease Global Medical Affairs and Global medical directors, regional and country medical affairs colleagues, Commercial and Product Management functions, and numerous other functions that require scientific expertise.

Job Responsibilities:

Scientific Affairs:

  • Oversee the development and execution the global strategy for scientific affairs and diagnostic programs for Lysosomal storage disorders; hemophilia, immune-mediated rare blood disorders and other rare conditions.

  • Continuously evaluate unmet needs in patient diagnostic journey to develop global strategy and guide prioritization of diagnostic investments at regional and country level.

  • Support policy development to facilitate execution of diagnostic initiatives.

  • Build strategy around patient diagnosis and monitoring to support product launches.

  • Build and maintain relationships between scientific community and Sanofi, exchanging scientific knowledge as appropriate and bringing back scientific insights from the community.

  • Develop and conduct training for internal colleagues on relevant laboratory medicine topics and support training opportunities for laboratories interested to get experience in rare disease diagnostics.

  • Ensure a patient-centric approach to development of scientific affairs activities with the highest level of scientific integrity.

Diagnostics:

  • Manage all aspects of partnering with external lab vendors and/or IVD manufacturers including RFP process, contract negotiations, statement of work, joint steering meetings, design control oversight, regulatory assessment and launch readiness.

  • Serve as the primary liaison between Sanofi and diagnostic laboratories, and lead technology transfer activities.

  • Support the development and implementation of an infrastructure to support global and local diagnostic programs.

  • Develop, execute, and manage global testing programs for patient diagnosis and monitoring Monitor and evaluate performance of medical services Plan and execute continuous improvement efforts based on data generated from these programs.

  • Lead and participate in quality improvement projects and development of guidance documents around lab diagnostics and medical devices.

  • Partner with local diagnostics colleagues to ensure seamless communication and synchronized execution of diagnostic programs.

  • Establish and maintain a network with local Sanofi affiliates focused on Medical Services responsible contracts and supports the local affiliates to ascertain compliance with local rules and regulations.

Digital

  • Support the develop innovative digital solutions to shorten patient diagnostic journey by exploration of digital technologies and external partnerships.

  • Build strategy for data and analytics to accelerate and optimize electronic health data driven diagnostics solutions.

  • Collaborate to develop and deploy framework for global to local collaboration to optimize approach to advanced analytics and machine learning model development and execution with pull through and KPIs that are closely aligned with business needs.

  • Implement training solutions to upskill the rare disease organization on digital solutions.

About you

Basic Qualifications

  • Education in life sciences subject and experience in the field – (BA, MSc, or a PhD).

  • At least seven years of experience in a relevant position, within research academic environment or laboratory experience and proven track record within the biotechnology and pharmaceutical industry.

  • Experience in technology transfer and validation.

Behavior Qualifications:

  • Strategy development ability, Critical analytical skills, and Learning agility. Excellent communication and presentation skills with the ability to present scientific data in a credible manner.

  • Ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena.

  • Highest integrity and commitment to ethics and scientific standards.

  • International and cross-cultural experience and savvy.

Why Choose Us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

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