Senior Clinical Research Director

Lead the clinical development plan strategies:

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  Prepare documents and presentations for internal governance meetings.

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  Responsible for the clinical development plans and clinical sections of integrated development plans (IDP).

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  Collaborate with other CRDs within the project, providing leadership and building consensus.

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  Coordinate action plans with stakeholders to resolve project-related study issues, anticipating potential issues (sharing lessons learned) across the project or study teams

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  Raise study or project-level issues to the project head.

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  Contribute to the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects.

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  Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators.

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  Evaluates relevant medical literature and status from competitive products.

Lead, support and oversee the execution of clinical development and studies activities:

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  Review and validate the clinical study report.

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  Develop the abbreviated protocol.

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  Review and validate the final protocol and protocol amendments.

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  Review the ICF WSI and TDF.

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  Co-Develop the SAP in collaboration with bio stats.

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  Responsible for key results preparation.

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  Develop the clinical study report.

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  Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs).

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  Medical support to clinical operation team during the clinical feasibility.

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  Review and provide clinical input across different study documents CRF, e-diary, monitoring plan.

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  Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with clinical scientist, bio stat and GSO.

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  Lead the study specific committees (IDMC, steering com, adjudication …) with operational support.

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  Answer to medical questions raised by EC/IRBs, sites.

Responsibilities related to regulatory and safety documents and meetings:

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  Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and projects.

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  Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP.

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  Supports registrations, label submissions and modifications.

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  Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP.

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  Contribute to the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP.

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  Ensures clinical data meets all necessary regulatory standards.

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  Participates in Advisory Committee preparation.

Scientific Data evaluation and authorship:

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  Participate and author manuscripts and abstracts.

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  Support the planning of advisory board meetings.

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  Establish and maintains appropriate collaborations with knowledge experts.

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  Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams.

Minimum Level of Required Qualifications: 

• Medical Doctor (MD) or equivalent

• At least 5 years experience in clinical development within the pharmaceutical industry or CRO

Preferred Qualifications: ​

• MD/PhD

• Specialty in Hematology

• Strong scientific and clinical acumen

• Expertise in clinical development, the methodology of clinical studies and life cycle management

• Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.

• Demonstrated capability to challenge decision and status quo with 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, demonstrated ability to assist and train others

• Ability to work within a matrix model.

• International/ intercultural working skills

• Open-minded to apply new digital solutions

• 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.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.