To provide strategic leadership and oversight of projects and activities for the Medical Function in the US. Major activities include strategic input and guidance to Medical Action Plans, oversight of phase IV and post-marketing clinical trials; support investigator-sponsored studies; interface, educate, and gain insights from external stakeholders, including government agencies, professional medical societies, guidance committees, key opinion leaders and key decision makers, on issues related to Sanofi Pasteur products; organize external expert advisory boards, scientific symposia, and CME programs; oversee Medical activities related to review of promotional and scientific materials; collaborate with Public Affairs, Commercial Operations, New Products, and many other internal stakeholders in support of our products; and provide medical leadership to guide internal and external decision-making.
Strategic Input to the Medical Function:
- Provide strategic input and guidance to the Medical Action Plans for Sanofi Pasteur vaccines in one or more franchises.
- Work with Medical and cross-functional internal stakeholders to develop strategic imperatives and downstream strategies and tactics to support our products.
- Develop Medical Action Plans for the franchise or product in alliance with the appropriate integrated evidence generation plan and integrated scientific communications plan.
- Develop tactics to execute the Medical Action Plans, including, but not limited to, advisory boards, 1:1 key opinion leader (KOL) meetings, presentations to professional medical societies and CDC/ACIP, abstracts and publications, and accredited and non-accredited symposia at congresses.
- Coordinate activities with Medical and other functions in Swiftwater, North America, and globally.
- Successful execution of the tactics noted above. Build strong relationships with KOLs, key decision makers (KDMs), health systems, CDC staff, medical society members, and other HCPs to ensure they are well informed of the value and medical benefit of our vaccines and products.
Clinical Trial Management:
- Design and execute Sanofi Pasteur-sponsored clinical trials, including Phase 4 post-marketing and observational studies, and oversee investigator-sponsored studies (ISSs).
- Consistent with Life Cycle Management and Global Brand Team strategies (i.e., Integrated Evidence Generation Plans [iEGPs]), design and execute clinical trials of our products.
- For Sanofi Pasteur-sponsored studies, develop the full protocol; identify potential investigators and study sites; oversee budget plans; collaborate with the Clinical Operations team including the clinical program manager, biostatistician, medical writer, and others; and ensure timely and successful execution, analysis and reporting of the trial.
- Review in detail the documents that capture clinical trial data, including diary cards and case report forms needed to successfully compile and analyze accurate and useful data.
- Monitor the safety of clinical trial participants by reviewing all serious and non-serious adverse events that are reported by the study sites in accordance with Good Clinical Practice (GCP) guidelines. Play a pivotal role in writing, reviewing, editing, and approving key regulatory documents for submission to the US Food and Drug Administration (FDA) and other health authorities, including the Clinical Study Report and Common Technical Document, if appropriate.
- Develop a publication strategy and ensure its successful execution.
- Encourage external experts to apply to Sanofi Pasteur for support for their ISSs of our products, including generation of real-world evidence, when they are aligned with Life Cycle Management and Global Brand Team strategies.
- Evaluate each ISS to determine whether it fits in the scope of the iEGP for a given product.
- Present the study to internal stakeholders and manage the relationship with the investigator.
- If approved, manage the contract, budget, and supply of product, and monitor the study’s progress.
- Ensure publication of study results by the investigators and submit data to the US FDA if appropriate for enhancement of the Prescribing Information.
- Successful execution of company-sponsored clinical trials and observational studies in compliance with GCP, International Conference on Harmonisation (ICH), and FDA guidelines.
- Analyses of data that lead to publications and enhancement of the Prescribing Information and marketing materials, if appropriate.
- Successful and timely submission of clinical trial data to the US FDA and other health authorities, as needed, in Clinical Study Reports and other documents. Successful completion of ISSs followed by publication of the data by external investigators and submission of data to the FDA, if appropriate.
Professional Societies and Thought Leaders:
- Direct interaction with key professional societies (e.g., AAP, AAFP, NFID, IAC, ACP), public health authorities (e.g., CDC, ACIP, AIM, state and local health departments), and key external experts (academic and community) to provide scientific education on disease states, epidemiology, and clinical trials of our products; support company positions; provide guidance on company products and related medical issues; and identify external opinions, perceptions, and trends.
- Lead external advisory boards to obtain insights relevant to licensed and investigational products.
- Generate professional contacts with key external experts (KEEs) through participation in professional meetings, provision of lectures, 1:1 meetings, and other appropriate interactions.
- Seek opportunities to be of service to medical societies, agencies, and KEEs. Organize and lead external advisory boards.
- Establishment of strong relationships with agencies and thought leaders so as to enhance our corporate professional image, improve understanding and use of our products, and impact relevant decision-making.
- Interact with internal and external audiences in order to provide education regarding topics relevant to the Company's mission, its products and positions.
- Prepare and present scientific medical information related to our existing and investigational products.
- Organize and lead Medical advisory boards of KEEs and educational programs (accredited and non-accredited symposia) at congresses.
- Participate and present data at meetings of global, national, regional or local professional medical societies; educational meetings organized by public health authorities; or other venues appropriate for medical presentations.
- Face-to-face, virtual (web-based), or other digital meetings and presentations to relevant groups.
- Assist Global Medical Information in addressing questions from HCPs about our products.
- Increased understanding of vaccinology, relevant epidemiology, and available technology to prevent diseases. Improved understanding of, and support for, Company products (licensed and investigational) and positions.
Cross-functional Engagement and Support:
- Provide expert medical opinion and medical leadership to internal cross-functional teams and contribute to the development and execution of strategies that benefit the Company. Provide medical leadership to the field-based Medical Science Liaison (MSL) team.
- Take a leadership position to guide steps necessary to achieve medical understanding of issues as they arise.
- Participate in the development of appropriate management strategies consistent with the medical facts.
- Interact externally with key professional societies, public health authorities, and key external experts to support company positions and expedite a successful management of issues related to our products.
- Participate in and contribute to new product launch teams.
- Work with R&D and Clinical Development teams to provide medical input to the design of phase 2 and phase 3 clinical studies.
- Provide medical guidance to internal Sanofi Pasteur customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) reports to the US FDA and other health authorities (e.g., Periodic Benefit-Risk Evaluation Reports [PBRERs], Development Safety Update Reports [DSURs], Risk Management Plans [RMPs], and other PV reports and plans).
- Actively engage with and support the MSL team: provide updates of results from clinical studies (Sanofi Pasteur-sponsored and ISSs); discuss pivotal publications related to our products, competitor products, and related disease topics and epidemiology; develop medical education materials for external audiences; and contribute to shared meetings with MSLs including development of medical strategy and tactical efforts.
- Successful management within cross-functional teams to resolve issues to the satisfaction of the Company and enhancement of Company reputation and protection of our products and positions.
- Demonstration of medical leadership on cross-functional teams and contribution of medical and clinical trial data necessary for PV reports.
- Build a collaborative and supportive relationship with the MSL team to strengthen their ability to successfully achieve the objectives of field medical activities, including medical education and engagement with KEEs.
- Build a collaborative relationship with R&D and Clinical Development to provide valuable input to pre-licensure studies.