MEDICAL DIRECTOR - GLOBAL MEDICAL EVIDENCE GENERATION, IMMUNOLOGY
Company: Sanofi Group
Location: Cambridge
Posted on: October 24, 2024
Job Description:
Job Title: Medical Director - Global Medical Evidence
GenerationLocation: Cambridge, MAAbout the JobWe 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.Medical Director - Global Medical
Evidence Generation supports disease registries, post-regulatory
authorization clinical trial programs, RWE and epidemiological
studies for Next-Gen Immunology pipeline assets. The Medical
Director will report directly to Global Medical Evidence Generation
Lead, Next-Gen Immunology Franchise and will be responsible for
operational excellence of the phase IV studies (clinical and RWE),
refreshing IEGPs annually and operationalizing the tactical
activities from the IEGP.With guidance from the Global Medical
Evidence Generation lead, the new director will be an integral part
of executing the global medical evidence strategy in line with the
IEGPs developed for pipeline assets supporting development and
preparation for the launch and post launch activities.---The
exceptional new hire will have strong expertise in designing and
executing epidemiological studies, phase IV clinical studies and
RWEs utilizing latest tools and technologies with a working
knowledge and background in R&D and/or Medical Affairs.
Expertise in immunology-inflammation space is desirable.Main
Responsibilities
- Provide strategic and operational input into clinical
development plans and post-marketing studies to ensure robust
evidence generation.
- Accountable for designingand overseeing the execution of phase
IV clinical trials, observational studies, and real-world evidence
(RWE) studies.
- Ensure the generation of high-quality, scientifically rigorous
evidence to support the safety, efficacy, and value of our
products.
- Lead the development of study protocols, statistical analysis
plans, and clinical study reports.
- Oversee the analysis and interpretation of clinical and
real-world data to generate meaningful insights.
- Ensure the accurate and timely dissemination of study results
through publications, presentations, and regulatory submissions in
collaboration with SciCom team.Stakeholder Engagement
- Build and maintain relationships with selected Global Key
Opinion Leaders (KOLs), academic institutions, and research
organizationsto identify evidence gaps and opportunities for
collaboration.
- Act as a representative of evidence generation team from Sanofi
at scientific conferences, advisory boards, and regulatory
meetings.
- Collaborate with biostatisticians, data scientists, and
external partners to leverage advanced analytics and innovative
methodologies.
- Collaborate with glocal cross-functional teams including
Medical TA, Clinical Development, Regulatory Affairs, HEVA, Market
Access, and Commercial to align evidence generation activities with
medical objectives.Compliance and Quality Assurance
- Accountable for ensuringall evidence generation activities
comply with regulatory requirements, Good Clinical Practice (GCP),
and company policies.
- In charge of implementingquality assurance processes to
maintain the integrity and credibility of generated evidence.
- In charge to monitorand manage budgets, timelines, and
resources for evidence generation projects.About YouDesired Skills
and Competencies
- Demonstratedexceptional experience in clinical research,
medical affairs, and real-world evidence generation.
- Demonstrated experience andknowledge of clinical trial design,
biostatistics, and data analysis.
- Demonstrated experience and proficiencyin regulatory
requirements and guidelines for clinical research and evidence
generation.
- Proven ability to lead and manage cross-functional teams in a
global environment.
- Excellent project management skills with the ability to
prioritize and manage multiple projects simultaneously.
- Exceptional written and verbal communication skills
- Strong interpersonal skills with the ability to build and
maintain relationships with internal and external
stakeholders.
- Strong analytical skills with the ability to interpret complex
data and generate actionable insights.
- Creative problem-solving skills with a proactive approach to
identifying and addressing challenges.
- High ethical standards and commitment to maintaining the
integrity of scientific research.
- Strong attention to detail and commitment to
quality.Qualifications Required
- MD plus related MSc/MPH or PhD in Epidemiology/Public Health,
or equivalent advanced degree in a relevant field.
- Minimum of 5 years of experience in clinical research,
RWE/Epidemiology, medical affairs, clearly demonstratingexpertise
in developing RWE/epidemiological studies, as well as study
management and publications.
- Prior experience in clinical trials, RWE/Epidemiological
studies including understanding of trial methodology, design,
management, and execution.
- Demonstrated experience in leading global evidence generation
initiatives as well as study management and publications.
- Professional fluency in EnglishWhy 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.#GD-SG ---#LI-GZ#LI-Onsite#vhdPursue progress , discover
extraordinaryBetter is out there. Better medications, better
outcomes, better science. But progress doesn't happen without
people - people from different backgrounds, in different locations,
doing different roles, all united by one thing: a desire to make
miracles happen. So, let's be those people.At Sanofi, we provide
equal opportunities to all regardless of race, colour, ancestry,
religion, sex, national origin, sexual orientation, age,
citizenship, marital status, ability or gender identity.Watch our
ALL IN video
(https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check
out our Diversity Equity and Inclusion actions at sanofi.com
(https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness)
!US and Puerto Rico Residents OnlySanofi Inc. and its U.S.
affiliates are Equal Opportunity and Affirmative Action employers
committed to a culturally inclusive and diverse workforce. All
qualified applicants will receive consideration for employment
without regard to race; color; creed; religion; national origin;
age; ancestry; nationality; natural or protective hairstyles;
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.Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Discover more about us visiting
www.sanofi.com or via our movie We are Sanofi
(https://youtu.be/96EwNjb1TLo)As an organization, we change the
practice of medicine; reinvent the way we work; and enable people
to be their best versions in career and life. We are constantly
moving and growing, making sure our people grow with us. Our
working environment helps us build a dynamic and inclusive
workplace operating on trust and respect and allows employees to
live the life they want to live.All in for Diversity, Equity and
Inclusion at Sanofi - YouTube
(http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
Keywords: Sanofi Group, Waltham , MEDICAL DIRECTOR - GLOBAL MEDICAL EVIDENCE GENERATION, IMMUNOLOGY, Healthcare , Cambridge, Massachusetts
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