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Vaccines Medical Head, RSV

Synthorx

Synthorx

Bridgewater, NJ, USA
Posted on Monday, January 22, 2024

At Sanofi, we chase the miracles of science to improve people’s lives. Scientific discoveries don’t happen overnight or without hard work, but our determination to find answers for patients motivates them to develop breakthrough medicines and vaccines – and to never settle.

From our beginning as a local French enterprise to our position as a leading global healthcare company, reinvention is in our DNA and reflects our quest to make life better for patients, partners, communities, and our own people.

Today, we are one company, driven by a unifying purpose and a common ambition. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people around the world.

Sanofi’s mission is to improve the lives of people everywhere through innovative medicines and vaccines. To do this, we apply new techniques to overcome barriers and accelerate progress. Our deep expertise in disease pathways helps us take aim at smart targets, while our unique technologies empower them to develop drugs, biologics, and genomic medicines with the potential to transform the practice of medicine.

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

About the Job:

Our Team:

This position is responsible for leading a team of global medical affairs professionals (mostly comprised of MDs, and PhDs) dedicated to supporting the Sanofi Vaccines RSV portfolio and playing a key leadership role in the clinical and commercial development of all products in it.

The Medical Head of RSV Franchise is a true business partner offering valuable medical expertise in a compliant and ethical way; the role contributes to the strategic objectives of Vaccines by managing the medical strategy and evidence generation for RSV in accordance with internal procedures and applicable regulations.

The Medical Head assures the delivery of the medical strategy plan and scientific activities, sharing medical expertise of functional areas such as marketing, clinical development, pharmacovigilance and regulatory in compliance with law, ethical/scientific principles, and Group products strategy. He/she will promote, develop, and maintain strong scientific and medical relationships, towards KOL and Public Health Bodies. Her/his activity will increase scientific credibility and ethical image of the Company facilitating and encouraging Group's product strategy.

Main responsibilities:

The Global Medical Franchise Head RSV will be expected to drive Medical activities for prelaunch, launch and post-launch products, including Beyfortus and our pipeline projects for RSV Vaccines Older Adults and RSV Vaccine Toddler.

The Global Medical Franchise Head RSV will oversee developing and ensuring the execution of the Global Medical Strategy for each project and product within the portfolio.

In the day-to-day business the Global Medical Franchise Head RSV will build strategic plans, supervise the implementation and execution of the medical plans across a broad range of countries in US, Europe, China, and other International Markets. The Head will manage direct and indirect reports and build external partnership with communicable diseases experts/ health care agencies/ regulatory agencies/ institutions and medical/ scientific organizations.

In addition, the incumbent will work closely with the Sanofi Vaccines Research and Development, Public Affairs, Regulatory Affairs, Commercial, Value and Access and Franchise and Product Strategy functions globally to support optimal life cycle management for all products.

Key responsibilities of this position will be :

1. Global leadership for Integrated Evidence Synthesis/ Generation for the Franchise

  • Ensure evidence generation activities implemented by the Clinical, Medical, Public Affairs, and Value and Access teams are optimally designed, resourced, and executed to achieve the right studies at the right time to support the launch and life-cycle strategies for the franchise

  • Ensure Integrated Evidence Generation Plans (iEGPs) for prioritized projects are developed and endorsed as early as possible, but no later than at time of clinical proof of concept.

  • For late development iEGPs to ensure that launch requirements are adequately identified and resourced, and that LCM strategies are included.

  • For LCM iEGPs to ensure that constant evaluation of medical, market and competitive insights are incorporated to optimize uptake and appropriate expansion of the product value.

  • At all stages of iEGP development to ensure that key market unmet needs are considered for the development and evolution of target value propositions, and wide consideration for the most efficient approaches for addressing evidence gaps, including real world evidence/ innovative methods to capture patient outcomes and demonstrate patient/ payer and health systems value.

2. Lead planning, resourcing, and budget decisions for the implementation of the Global Medical Strategy for the franchise in alignment with long-term R&D and Commercial strategies, including

  • Long-range plans for Medical evidence synthesis or generation (Global Medical Roadmaps or GMRs), to support pre-launch, launch, and life-cycle strategies of Sanofi vaccines

  • Medical-scientific communication strategy (integrated Scientific Communication Plans or iSCPs) to ensure timely, effective, and appropriate communication and content regarding the balance of benefits and risks and value of the relevant franchise products

  • Scientific and public health expert engagement strategy (medical Stakeholder Engagement Plans or mSEPs) to ensure medically compliant expert and advocacy networks are built and sustained in alignment with planned launches, and public and private market access strategies

  • Provision of Medical advisory support to partner functions for the development of Commercial, Regulatory, R&D strategies for specific brands/ franchises/ R&D projects.

3. Ensures Global Medical Action Plans are aligned with the achievement of Brand plans, Launch Excellence Plans, Unified Voices Plans and other cross-functional activities that support strategic products

  • Coordinate across-portfolio prioritization for medical-scientific activities

  • Provide guidance and leadership to ensure compliance with company policies and processes and regional/ local regulations

  • Make prioritization decisions for resourcing and budgeting of Medical activities and provide strategic input for prioritization of inter-dependent evidence generation activities

4. Medical-Scientific thought leadership for the franchise

  • Senior Medical spokesperson for interactions with key decisions makers, e.g., WHO, key national immunization advisory groups

  • Medical leadership on franchise related benefit-risk assessments/ recommendations in conjunction with pharmacovigilance, pharmacoepidemiology and clinical sciences teams

  • Senior Spokesperson for the company on critical medical issues relevant to the franchise

5. Cross-functional strategic alignment

  • Ensure Unified Voice to external stakeholders by working in constant collaboration with Public Affairs, Value and Access, Market Access teams to drive coordinated medical, public affairs and market access activities on strategic projects and

  • Ensure close collaboration with GBT Countries and Regional Medical teams to capture synergies and cross-regional best practices.

  • Lead the Global Medical teams for PPH representatives of the regions, GBT markets, Medical Evidence Generation, Medical Insights, Medical Operations, congress, publications and content, PV and Pharmaco- epi teams

6. People and Talent strategy leadership

  • As a Medical Leadership Team member, provide critical input to ensure Medical strategic workforce plans at Global, but also across the countries, match the portfolio needs for pre-launch and lifecycle activities

  • Drive Medical Excellence through Medical competency development initiatives, including talent management, training programs, mentorship and coaching for direct team members as well as other key talents within the wider medical organization

  • Holds individuals and teams accountable for their performance & promotes the culture of high performance within the team

· Develops teams to the aspirational profiles of the Medical function and identifies suitable candidates for succession planning needs

7. Medical governance leadership

  • Ensure culture and systems enhance medical governance and compliance with Sanofi and Sanofi Vaccines principles and processes, and applicable external regulations.

  • Accountable for Medical approvals for Medical-marketing activities, including review of promotional material, Congress participation, speaker selection, HCP engagements, CME/ research grants, sponsorships and donations and transparency documentation

  • Ensures governance processes for iEGP/ iSCP/ GMR/ mSEP/ Benefit-risk assessments and study protocols conducted in accordance with Sanofi and Sanofi Vaccines processes

8. Responsibility and accountability for the financial management and reporting requirements for the Medical functions, including supporting the Finance reporting process with accurate and timely data and assumptions as needed to support budgeting, forecasting and long-range planning for the business units. Manage the budget of the Medical PPH

.

About You:

  • Education: Medical Degree preferable or PhD with significant vaccinology or infectious disease expertise (e.g. Virology/ Microbiology/ Respiratory Medicine/ pediatric or public health)

  • Experience: Significant experience in clinical development/ real world evidence, launches and post-marketing medical activities on a global level

  • Skills

​ - At least 10 years leadership and management experience in medical activities or other aspects of the life sciences, including budget management and preferably leading an international team

-Demonstrated ability to work effectively in a matrixed environment and across geographies

-Highly team oriented with outstanding interpersonal skills and ability to collaborate effectively with other groups, as well as a demonstrated ability to see the big picture and develop project strategies while not losing focus on project specifics.

-Strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards is required.

- Proficient in public speaking, with demonstrated strength in interacting with external stakeholders (health authorities, scientific medical societies etc.)

  • Languages: Fluent in English

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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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.