Job Title: Development Scientific Director
Location: Cambridge, MA
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The clinical scientist is a responsible member of the clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The primary purpose of the Clinical Scientist's position is to support the Clinical Research Director (CRD) and/or clinical lead in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to key study documents and activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes.
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We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Clinical scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity, provide input to the clinical development plan, work on the development of the clinical trial protocol, clinical trial materials, and take responsibility for coordinating completion of clinical study reports and support preparation of relevant documents for regulatory filings.
This role will involve extensive team matrix interactions with colleagues from a number of different disciplines. This individual may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.
Under the guidance of his/her manager in the Therapeutic Area department, he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed. He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
Main Responsibilities
- Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study reports, committee charters, protocol registration form, redacted protocol, lay summary ...).
- Supports CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project
- Contributes to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan
- Is involved in the update of study documents, eCRF adequacy with protocols/protocol amendments and helps in rationalizing and documenting the data collection needs quantitatively and qualitatively and decreasing the complexity
- Develops study specific training material and participates in the Investigator Meetings, scientific advisory boards, and training of study Teams and monitoring teams
- Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to GPV or safety events of special interest), notably to anticipate and prevent last minute queries or backlog and smoothen the process.
- Supports CRD in implementing, managing, organizing, and conducting Steering committees, Data Monitoring Committees, Adjudication Committee meetings
- Supports to regulatory documents filing and archiving. Interpret, report and prepare oral and written results of product research, in concert with senior clinical personnel, in preparation for HA submissions.
- Review of study plans, study reports, publications for accuracy with clinical study report as well as ensuring completeness of study reports appendices under the responsibility of the CRD.
- May be asked to support the execution of contracts related to clinical studies and to assess medical publications emerging from the team and its affiliates.
- May be asked to support business development activities as it pertains to the clinical development unit.
About You
Knowledge/Skill Requirements
- Ophthalmology/retina clinical development experience required
- Scientific expertise or interest and ability to learn in the domain of assigned study/project.
- Well organized, high level of autonomy and motivation,
- Leadership to give directions and organize the activities on behalf of the CRD
- Quality focused, able to develop good practices, using a critical data-driven and risk management approach
- Familiar with digital tools such as data analytics or agility to use them
- Good communication skills (verbal and written)
- Multiple tasks handling and prioritization
- Ability to synthesize the information, good presentation skills
- Ability to work autonomously and efficiently to provide status reports and to anticipate and escalate issues in a timely manner to execute action plans
- Able to make proposals to manage challenging situations
- Ability to work in project mode with study team and CRDs and develop trust and effectiveness
- Management of priorities and workload, if involved in several projects
- Ability to develop strong leadership and collaborate with cross functional team members
- Team and results oriented
- Experience of working internationally with Strong English skills (verbal and written if English is not the native language)
- This position may require up to 15% travel
Formal Education And/Or Experience Required:
- Ph.D., O.D. or similar; Bachelor's and Master's degrees considered for candidates with extensive experience.
- A minimum of 7 years of clinical research and clinical drug development experience within the ophthalmology/retina pharmaceutical industry or CRO is required
- Knowledge in ICH, GCP.
- Fluent in English
Knowledge And Skills Desirable But Not Essential:
- Clinical operations, statistical, data management and regulatory knowledge
Why 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.
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