Senior Clinical Research Director

Sanofi • Cambridge, MA

4d • $236,250 - $393,750 • Hybrid

About The Position

The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs and provides medical leadership for clinical development plans, studies, and related regulatory activities. The role mentors Clinical Research Directors and Clinical Scientists, aligns operational approaches across functions, builds consensus among project stakeholders, anticipates and escalates project or study issues, and shares relevant lessons and information across teams.

The Sr CRD provides medical expertise for clinical studies and registries, supports clinical development activities such as feasibility, data review, and risk assessment, and contributes clinical content to regulatory submissions and responses to health authorities. The role works with clinical operations, project management, biostatistics, pharmacovigilance, regulatory, investigators, external partners, and other stakeholders to ensure clinical data are medically relevant and study execution meets Good Clinical Practice, applicable laws and regulations, and standard operating procedures.

The position also contributes to scientific communications and strategy, including manuscripts, abstracts, advisory boards, collaborations with experts, and evaluation of potential in-licensing candidates. The role is based in Cambridge, Massachusetts; the posting indicates a hybrid work arrangement.

Requirements

• Medical Doctor (MD) or equivalent.
• At least 5 years of clinical development experience within the pharmaceutical industry or a CRO.
• Strong scientific and clinical acumen.
• Expertise in clinical development, clinical study methodology, and life cycle management.
• Excellent verbal and written communication skills for cross-functional and regulatory-agency interactions.
• Demonstrated ability to challenge decisions and the status quo using a risk-management approach.
• Ability to negotiate to ensure operational resources are available for continued clinical conduct.
• Fluency in written and spoken English.
• Excellent teaching skills and demonstrated ability to assist and train others.
• Ability to work within a matrix model.
• International and intercultural working skills.
• Open-mindedness toward applying new digital solutions.

Nice To Haves

• MD/PhD.
• Specialty in Hematology.

Responsibilities

• Mentor other Clinical Research Directors and Clinical Scientists within projects or therapeutic areas.
• Collaborate across functions to align operational approaches and harmonize study documents, essential study materials, and protocols.
• Lead project-level coordination and consensus-building with other CRDs and stakeholders; coordinate action plans, anticipate issues, share lessons learned, and escalate study or project issues to project leadership.
• Provide medical expertise to clinical studies and registries, including protocol, key results, and clinical study report work.
• Support clinical development activities, including feasibility assessment, medical review and validation of clinical data, and study risk assessment.
• Contribute clinical content to submission dossiers and responses to health authorities, including FDA and EMA submissions and filings in Japan and China.
• Provide medical input and support for clinical study activities, including training, feasibility, data review, study-team medical information, and support for clinical project leaders and investigators.
• Serve as the medical reference for the Clinical Study team and ensure the medical relevance of clinical data.
• Interact with CRDs, the Global Project Head, Pharmacovigilance, Regulatory, and other key functional representatives.
• Lead clinical development plan strategies and prepare documents and presentations for internal governance meetings.
• Own clinical development plans and clinical sections of integrated development plans.
• Contribute to the product value proposition, target product profile, market access strategy, and research strategy by providing input on clinical needs and development approaches.
• Collaborate with external partners, regulators, and internal stakeholders; evaluate relevant medical literature and the status of competitive products.
• Review and validate clinical study reports, final protocols, protocol amendments, informed-consent materials, and other study documents; develop abbreviated protocols and key results.
• Co-develop statistical analysis plans with biostatistics and develop clinical study reports.
• Oversee trial timelines, budgets, and contingency and risk-management plans with support from related functions, ensuring compliant execution.
• Provide medical support to clinical operations during clinical feasibility and review clinical input across study documents such as CRFs, e-diaries, and monitoring plans.
• Ensure continuous medical review of aggregated data during clinical trials with clinical scientists, biostatistics, and GSO.
• Lead study-specific committees, including independent data monitoring, steering, and adjudication committees, with operational support.
• Answer medical questions from ethics committees, institutional review boards, and study sites.
• Represent projects at regulatory agency meetings as the medical spokesperson for studies and projects.
• Lead the strategy and structure of clinical sections for BLA/CTD submissions, regulatory meeting briefing packages, and PSP/PIP; support registrations, label submissions, and modifications.
• Review or contribute to clinical sections of investigator brochures, CTAs, INDs, DSURs, INDARs, DRMPs, and RMPs; ensure clinical data meet regulatory standards.
• Participate in Advisory Committee preparation.
• Participate in and author manuscripts and abstracts; support advisory board planning and establish collaborations with subject-matter experts.
• Contribute to ad hoc evaluations of potential in-licensing candidates in the I&I therapeutic area and serve as a clinical advisor to research teams.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs; further details are available through the company benefits information.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree