Senior Clinical Research Director - Oncology
Sanofi
11 days ago
Remote friendly (Morristown, NJ)
United States
$236,250 - $393,750 USD yearly
Clinical Research and Development
Main Responsibilities:
- In a matrix model, establish/adapt clinical development and contingency plans by engaging with 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 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 optimize trial planning and execution.
- Present/discuss development strategy and clinical results with internal stakeholders, external investigators, advisory boards, and regulatory authorities.
- Author clinical abstracts, conference presentations, and manuscripts.
Qualifications & Experience:
- MD (or equivalent); oncology and/or hematology training; myeloma/hematologic malignancies experience a plus.
- At least 4 years’ experience in clinical development in pharma, CRO, or healthcare institution.
Skills (required/preferred):
- Excellent verbal/written communication in English with internal/external stakeholders.
- Problem solving; risk-management approach; challenges the status quo.
- Ability to work in cross-functional teams to meet milestones.
- Understanding/willingness to meet regulatory, quality, and compliance standards.
- Quality-focused; data-driven and open to digital solutions.
- International/intercultural working skills.
Preferred location: Cambridge, MA; Morristown, NJ; Vitry, France considered.
Benefits (if part of description): Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- In a matrix model, establish/adapt clinical development and contingency plans by engaging with 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 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 optimize trial planning and execution.
- Present/discuss development strategy and clinical results with internal stakeholders, external investigators, advisory boards, and regulatory authorities.
- Author clinical abstracts, conference presentations, and manuscripts.
Qualifications & Experience:
- MD (or equivalent); oncology and/or hematology training; myeloma/hematologic malignancies experience a plus.
- At least 4 years’ experience in clinical development in pharma, CRO, or healthcare institution.
Skills (required/preferred):
- Excellent verbal/written communication in English with internal/external stakeholders.
- Problem solving; risk-management approach; challenges the status quo.
- Ability to work in cross-functional teams to meet milestones.
- Understanding/willingness to meet regulatory, quality, and compliance standards.
- Quality-focused; data-driven and open to digital solutions.
- International/intercultural working skills.
Preferred location: Cambridge, MA; Morristown, NJ; Vitry, France considered.
Benefits (if part of description): Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.