Senior Clinical Research Director - Oncology
Sanofi
10 days ago
Remote friendly (Cambridge, MA)
United States
$236,250 - $393,750 USD yearly
Clinical Research and Development
Main Responsibilities:
- Working in a matrix model, establish or adapt clinical development and contingency plans by engaging with clinical investigators, advisors, and regulatory authorities.
- Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD filings, annual reports, and development risk management plans.
- Lead the clinical interpretation of study results.
- Contribute to clinical study reports and clinical summaries, including regulatory submissions.
- Provide expert medical guidance to Clinical Operations, Biostatistics, and Translational Medicine to ensure optimal planning and execution of clinical trials.
- Present and discuss development strategy and clinical study results with internal stakeholders, external investigators, advisory boards, and regulatory authorities.
- Author clinical abstracts, conference presentations, and manuscripts.
Qualifications:
- Education: MD (or equivalent); oncology and/or hematology training; experience in myeloma/hematologic malignancies is a plus.
- Experience: At least 4 years of clinical development experience in the pharmaceutical industry, CRO, or healthcare institution.
Skills/Soft Skills (required/preferred):
- Excellent verbal and written English communication with internal and external stakeholders.
- Problem-solving ability.
- Risk-management approach; ability to challenge decisions and status quo.
- Demonstrated ability to work with multi-functional teams to meet project milestones.
- Understanding of and willingness to meet regulatory, quality, and compliance standards.
- Quality-focused; data-driven and open to new digital solutions.
- International/intercultural working skills.
Preferred location: Cambridge, MA; Morristown, NJ; Vitry, France considered.
Benefits (explicitly stated): At least 14 weeks’ gender-neutral parental leave, plus health and wellbeing benefits (healthcare, prevention, and wellness programs).
- Working in a matrix model, establish or adapt clinical development and contingency plans by engaging with clinical investigators, advisors, and regulatory authorities.
- Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD filings, annual reports, and development risk management plans.
- Lead the clinical interpretation of study results.
- Contribute to clinical study reports and clinical summaries, including regulatory submissions.
- Provide expert medical guidance to Clinical Operations, Biostatistics, and Translational Medicine to ensure optimal planning and execution of clinical trials.
- Present and discuss development strategy and clinical study results with internal stakeholders, external investigators, advisory boards, and regulatory authorities.
- Author clinical abstracts, conference presentations, and manuscripts.
Qualifications:
- Education: MD (or equivalent); oncology and/or hematology training; experience in myeloma/hematologic malignancies is a plus.
- Experience: At least 4 years of clinical development experience in the pharmaceutical industry, CRO, or healthcare institution.
Skills/Soft Skills (required/preferred):
- Excellent verbal and written English communication with internal and external stakeholders.
- Problem-solving ability.
- Risk-management approach; ability to challenge decisions and status quo.
- Demonstrated ability to work with multi-functional teams to meet project milestones.
- Understanding of and willingness to meet regulatory, quality, and compliance standards.
- Quality-focused; data-driven and open to new digital solutions.
- International/intercultural working skills.
Preferred location: Cambridge, MA; Morristown, NJ; Vitry, France considered.
Benefits (explicitly stated): At least 14 weeks’ gender-neutral parental leave, plus health and wellbeing benefits (healthcare, prevention, and wellness programs).