Clinical Research Director - RBD
- The CRD is expected to be a principal team member within the development group. He/she provides medical and scientific leadership in the development of new therapies. The CRD is responsible for the clinical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP.
- The CRD will become an expert in the disease and experimental therapy for which he/she is responsible. This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. The CRD will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff.
- The CRD works with the Clinical Science Operation (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct and preparation of study reports.
- The CRD leads the Clinical Development Subteam (CDST) working closely with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy. In this role, the CRD provides clinical input and leadership into the activities of this team in close collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP in accordance with the product profile and corporate goals.
- In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other members of the CDST (i.e., GPH, CSO PL, regulatory, statistics, and PM)
- The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with regulatory authorities.
- The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning.
- In support of licensing and acquisition activities, the CRD will work in concert with business development and provide medical due diligence on opportunities.
- The CRD will liaise with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies, contribution to and review of manuscripts that involve Sanofi sponsored studies.
- The CRD will liaise with the Research group in the therapeutic area, contributing to the overall science discovery strategy and providing medical assessment of disease and therapeutic targets.
- MD
- 5 + years of pharmaceutical/biotechnology industry or combined industry/ academic experience, with experience in clinical trials
- A working knowledge of GCP
- Preferred Qualifications:
- Specialization in hematology preferred
- Academic experience as a principal investigator a plus
- Strong analytic thinking and the ability to assess scientific data and medical literature
- Excellent written and verbal communication skills. Experience writing abstracts/manuscripts/study reports strongly desired
- Collaborative team work ethic.
- Ability to work and lead a matrix team
- 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.
#LI-SA #LI-Onsite
#vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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