Principle Clinical Research Director - Gastronenterology

The Principle Clinical Research Director (CRD) is noted as the primary clinical lead for complex

programs, especially those with multiple indications. The role requires a highly resourceful individual with outstanding strong emotional intelligence, self-motivation, solid analytical skills and the ability to be a strong leader. The candidate is considered a “Top-of-Class” expert in the respective therapeutic area (TA).

This role is highly strategic and facilitative that requires a combination of focus and flexibility, as well as a willingness to play an active role to support clinical activities across the project. The role requires leading a team to support continued clinical activities across a complex program while supporting other CRDs at the team level. The Principle CRD should be a key partner to the Global Project Head with a focus on clinical activities and supporting design and strategy for evidence generation.

The role of the Principle CRD is to:

• Lead the creation and implementation of clinical development plan strategies

• Manage CRDs and Clinical Scientists within project and across the Early development team if needed

• Lead/Act as a mentor for other CRDs and Clinical Scientists within the project and across the TA

• Collaborate with functions to ensure uniform, aligned operational approach (e.g. harmonizing study documents, ES, protocols, etc.). Within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams.

• Lead clinical activities:

• Provide clinical expertise for project team and broader TA

• Support study related clinical activities, e.g. protocol development, pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment

• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators

• Coordinate with other CRDs in the project, Global Project Head, Translational Medicine, PV, Regulatory and other key functional representatives

Key responsibilities include:

Clinical development plan strategies:

• Clinical strategy: Lead development and assessment of clinical scenarios in alignment with Global Project Head

• Internal Governance: Preparation of documents and presentations for internal governance meetings

• Collaborate with other CRDs within the project, provide leadership, build consensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project or study teams

• Contribute to the definition of the product value proposition (TVP), TPP and market access strategies (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

• Lead engagement and collaboration with internal and external partners, regulators, and experts

Execution of clinical development and studies activities:

• Lead study implementation and remediate study issues

• Review and validate the clinical study reports and key results memos

• Oversee and provide accountability for study related clinical activities

• Abbreviated protocol development

• Review and validation of final protocol, protocol amendments and study supporting documents

• Co-develop the SAP in collaboration with bio stats

• Responsible for key results preparation and clinical study reports

• 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)

• Medical support to clinical operations team during clinical feasibility

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

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

• Answer/respond to medical questions raised by HA/EC/IRBs, sites, etc.

Regulatory and safety documents and meetings:

• Represents the Project at key regulatory agency meetings as the medical spokesperson for the studies and broader project.

• Oversees and is accountable for clinical input into key regulatory documents:

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

• Supports registrations, label submissions and modifications: Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP documents for project in late stage

Clinical expertise, scientific data evaluation and authorship:

• TA level expert/referent in the field of inflammatory bowel diseases.

• Establishes and maintains appropriate collaborations with knowledge experts

• Evaluates relevant medical literature and status from competitive products

• Leadership role in the planning and execution of advisory board meetings

• Participates in the authorship of program related abstracts and manuscripts

Experience:

• Broad understanding of pharmaceutical product development and life cycle management gained through 5+ years of clinical development/medical experience

• Robust scientific and medical expertise in the field of immune driven disease; ideally in inflammatory bowel disease

• Outstanding expertise in clinical development and methodology of clinical studies

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

• Ability to influence and negotiate to ensure operational resources are available for continued clinical conduct

• Strategic leadership with a robust understanding of the drug development value chain

• 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

Minimum Level of any Required Qualifications:

• Medical Doctor (MD): Gastroenterologist and/or experience in internal medicine and immune driven diseases

• Fluency in written and spoken English

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.

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