Principal Clinical Research Director, Immunology in Cambridge, Massachusetts
The Principal Clinical Research Director is noted as the primary clinical lead for complex priority programs, especially those with multiple indications. The role requires a highly resourceful individual with outstanding strong emotional intelligence, self-motivation, solid analytical skills and the ability to be a strong leader. The candidate is considered a “Top-Class” expert in the respective therapeutic area (TA).
This role is highly strategic and facilitative that requires a combination of focus and flexibility, as well as a willingness to play an active role to support clinical activities across the project. The role requires leading a team to support continued clinical activities across a complex program while supporting other CRDs at the team level. The Group/Principal CRD should be a key partner to the Global Project Head with a focus on clinical activities and supporting design and strategy for evidence generation.
Key responsibilities include:
Support the project activities by focusing on the strategic clinical approach to the collective program
Manage and mentor a team of expert Clinical Research Directors (CRD) supporting the collective program
Support the team with key interactions from other functions (i.e., Regulatory, Medical, Pharmacovigilance, Clinical Pharmacology, Biostatistics, etc.)
Oversee and provide clinical support for the clinical studies (except select Exploratory Pharmacology studies) and/or registries (e.g., Study Protocol, Key Results Memo, Clinical Study Report)
Support the TA CRDs with other clinical development activities (e.g., “pressure test” and cluster feasibility, medical review and validation of clinical data, study risk assessment)
Contribute to the clinical part of Common Technical Document for any regulatory submissions
Play key role aligning on standardizations and activities in for the Protocol Review Committees
Serve as expert clinical reference in the Program, ensuring the medical relevance of the clinical data across all studies with the project.
Serve as expert clinical reference for the molecule development program, ensuring operational delivery (e.g., harmonizing study documents, protocols, etc.), building consensus, coordinating action plans with other CRDs and stakeholders to resolve project-related study issues, anticipating potential issues (sharing lessons learned) across the project or study teams. Raises study or project-level issues to the Global Project Head and TA as relevant
Broad understanding of pharmaceutical product development and life cycle management gained through 6-8 years in development experience for a Principal CRD
Outstanding scientific and medical expertise
Outstanding expertise in clinical development and methodology of clinical studies
Demonstrated strong leadership, foster team motivation, ability to influence and drive decisions
Outstanding communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Demonstrated capability to challenge decision and status quo with a risk-management approach
Ability to negotiate to ensure operational resources are available for continued clinical conduct
Outstanding intercultural/international working skills
Open and preferably experienced in digital solutions
Minimum Level of any Required Qualifications:
Medical Doctor (MD) required: GP or specialist
Completion of a fellowship program in one of the following subspecialties: pulmonary, allergy/immunology, dermatology, or rheumatology
Fluency in written and spoken English
LOCATION : open to applicants on East Coast and Europe
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.