Medical Director, Pulmonary Job at Sanofi (Cambridge)

Job Description

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you’ll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. Our Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients’ needs. The US Medical Immunology team is proud to support Sanofi’s deep commitment to chasing the miracles of science to improve the lives of patients. We shatter treatment inertia through our commitment to leaving no patient behind. We aim to transform medical practice, deliver innovative and actionable data to providers and payers enabling timely patient identification and driving the urgency to act on debilitating immunological disorders. The Medical Director, Pulmonary functions internally as the product expert to lead the development and execution of the most efficient and integrated US medical/scientific strategy for Pulmonary products, including scientific evidence generation and scientific information exchange with all key stakeholders. As a valued strategic partner with the Medical Field Team, Clinical, Commercial, Regulatory and Market Access this role is essential to success is an outstanding partnership to maximize the value proposition. Externally, the role assists healthcare professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions. This medical leader is responsible for co-developing the U.S. medical strategy and tactical plan for their entire Therapeutic Area and ensure delivery. This includes a strong partnership with field teams, global teams, alliance management and the relevant U.S. cross-functional partners and ensuring these plans are tailored to the local needs and resources, both on data generation and all aspects of engagement with the scientific community.

Job Responsibility

Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned the respective therapeutic area products
Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables
Communicate the details and Progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution
Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans
Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of the respective therapeutic area products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities
Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development
Pro-actively provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, managing resources and budgets.
Partner with Field Medical Head, Medical Directors, and other internal partners to manage high-level regional stakeholder relationships, contribute to medical engagement planning, and oversee the tactical budget.
Collaborate with the health economics team to address questions and opportunities
Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
Review and approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials
Provide medical review of applications for independent medical education grants
Provide medical review of training materials for medical and commercial employees
Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law (including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR)
Support the execution of US Phase IIIB-IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines, and accurate and timely reporting of study data
Oversee conduct of all clinical studies in adherence to both Company standards and government/industry regulations (GCP/ICH)
Review and approve IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOPs
Identify and co-create research collaboration opportunities within the respective therapeutic area to address key questions in the delivery of patient care
Identify needs for post-marketing clinical trials and registries and oversee their management and execution
Ensure that all data generated by the company or investigator-sponsored trials are publicly presented in an appropriate and timely fashion and in a fair and balanced manner
Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals
Identify and communicate Product Alerts to the Core Team (in conjunction with US Drug Safety, USRAMP, GMA)
Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within the respective therapeutic area medical and scientific community
Lead medical and scientific advisory board discussions to identify and elevate medically focused opportunities, resources, and strategic action within Pulmonary
Foster the establishment and maintenance of external scientific advisory boards and assist in advocacy development
Interact with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in the therapeutic area
Provide disease state and product training to internal and external stakeholders
Remain informed of current developments within the respective therapeutic area medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, and professional associations
Performs other duties as assigned.

Requirements

Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, PA, NP or MD with relevant experience)
Minimum 5 years of relevant experience in Medical Affairs
Strong track record in developing and executing medical strategies in the US
Clinical or medical affairs experience in Pulmonary and/or Immunology strongly preferred
Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities
High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies
Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale
In-depth understanding of how to conceptualize, design, and conduct clinical trials. Experience in clinical trial design and execution preferred
Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities
ability to translate innovative strategies or solutions into actionable plans
Thinks strategically leveraging knowledge of general business practice, the industry, medical practice and Sanofi strategic objectives to create a team strategy to achieve commitments
Effective internal and external stakeholder management
politically astute with strong cross-functional teamwork and collaboration. A team player
able to collaborate successfully with both internal and external colleagues
Broad leadership experience with excellent leadership presence to represent Medical Affairs within the company, to other functions, and to leaders at every level
Excellent skills working with experts from other functions, influencing decision-making without authority in a complex and matrix environment
Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders
Driven to develop and execute optimal strategy meeting corporate objectives while creating pragmatic solutions
comfortable with ambiguity and ability to adapt with agility
Strong interpersonal skills with the ability to influence others
Excellence in solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
Excellent communication skills both written and oral, including strong presentation skills
The highest personal integrity
committed to ethics and scientific standards
High energy and absolute commitment to a culture that operates with high ethical standards
Strong analytical skills
comfort managing through ambiguity
Understanding and success in dealing with different cultures
Proven ability to utilize appropriate time and project management strategies and agility, to manage complex environment and excellent ability to prioritize and manage expectations
A lifelong learner who consistently seeks opportunities to learn
Knowledge of pharmacovigilance and local regulatory process
Proven record of successful change management, a Change Champion mindset
Digital literacy
Travel: Ability to travel up to 35% of the time to customers, external meetings, trainings, and other internal meetings.

Nice to have

Clinical or medical affairs experience in Pulmonary and/or Immunology
Experience in clinical trial design and execution

What we offer

High-quality healthcare
Prevention and wellness programs
At least 14 weeks gender-neutral parental leave

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Medical Director, Pulmonary

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