Clinical Research Director, Oncology Early Development
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At Sanofi, this is an exciting time to join our Early Development Oncology team with our diversified and growing internal pipeline, enriched by the recent acquisition of Synthorx, on the vanguard of gene-edited treatments. Our Oncology team is expanding to support our growing programs, and we seek candidates who want to create life-changing treatments for cancer patients.
This individual will report to the project physician or Head of Oncology Early Development, and will interface with all functions to support the development of novel anti-cancer therapeutics. This role is under the supervision of Clinical Lead for all designated clinical study related activities including but not limited to preparation, execution, reporting, strategic decision-making, investigator/Ad Board/DMC/Other External Meeting, and regulatory submission/consultation.
The Clinical Research Director will:
- Play a key role among a group of physicians and scientists particularly on studies with oncology assets in early development
- Serve as Study Monitor on the assigned clinical trials, also functioning as critical connection ring between strategy and execution, acting as the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
- Provide support to the Clinical Lead for the assigned trials
- Closely interface with Clinical Operations, Regulatory, Biostatistics, TMED, PK, Data Mgmt and all functions related to study conduct
- Support the Clinical Lead contributing to strategy, clinical development plans, review of pre-clinical packages
- Ensure strategic execution according to the protocol and study plan (under direction of the Clinical Lead)
- Support creating and communicating the vision for the Clinical Program
- Design, implement, and interpret creative clinical trials whose outcomes define usage of the drug and create opportunities for a commercially successful product
- Work transversally with colleagues from Development, Medical Operations, Clinical Operations, Translational Research, Pharmacology, Biomarkers, Statistics, Safety, Competitive Intelligence, and all other functions pertinent to the project, to harmonize translating the strategy into execution in assigned studies, to support updating the strategy based on competitive intelligence, early clinical data, new scientific knowledge, to prepare essential clinical study documents
- Prepare and review synopses, protocols and amendments, the IB, clinical sections of IND/IMPD, CTAs filings, annual reports, clinical study reports, risk-management plans, and regulatory documents (INDs, NDAs) under the supervision of the Clinical Lead and Project Head
- Assist in the preparation and conduct of study trainings for investigators, study sites, internal colleagues
- Perform data interpretation and analysis to assess the impact on project objectives and deliverables
- Participate in the preparation of registration clinical documentation (labeling, CTDs, overview summaries)
- Prepare responses for clinical questions from health authorities
- Provide feedback to the clinical study team regarding study conduct (contribute to discussions regarding adjustments in the study and/or strategy based on the data)
- Under guidance from and in alignment with Clinical Lead, may act as a Dedicated Project Expert (DPE), and may mentor project Scientists
- Closely monitor and support study start up, opening of sites, data collection
- Support design and management of Advisory Boards (content and strategy), strategic committees, Data Monitoring Committee and any other ad-hoc committee meetings
- Provide scientific support for clinical data review and interpretation including safety and efficacy
- If asked, participate in meetings with health authorities for development and registration purposes
- Author and review clinical abstracts and presentations for conferences when appropriate
- Assess go/no go points for each indication
- Manage relations with investigators and study sites
- Possibly support transition of new preclinical assets to the clinic
- MD degree
- Oncology fellowship or 5+ years of experience in Clinical Oncology
- Open, collaborative, transparent working style
- Ability to synthesize and explain complex topics to non-experts
- Ability to collaborate effectively with all personnel involved in clinical research
- Strong analytical skills including the assessment of scientific data and medical literature. Excellent written and verbal communication skills
- Knowledge of applicable regulatory, quality and compliance standards
- 5+ years industry experience or academic clinical research experience
- Experience with immuno-oncology therapies
- Experience authoring posters, oral presentations and/or peer-reviewed papers
- Ability to communicate effectively on complex medical/scientific issues and build consensus
- Demonstrated ability to interact productively with and attract top external investigators
- Experience in creating and driving a clinical plan
- Experience leading teams
- Experience to drive project milestones and work with a global team
- Contribution to the successful strategic development of compounds through phases of clinical research
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.
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.
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