The Principal Clinical Research Director is the **primary senior clinical lead for a clinical development program** , reporting into the Global Project Head (GPH), and managing a team of Clinical Research Directors and Clinical scientists.

The role requires a well-organized, experienced, strategic focused and resourceful individual with interpersonal skills, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

The role will focus on autoimmunity and solid organ transplant with direct accountability for the Frexalimab program and with a supporting role for a few earlier stage programs in the field of autoimmunity.

The role is to:

Lead the clinical development plan strategies and implementation for frexalimab in I&I indications and coordinate clinical activities across indications and TAs

Lead a clinical team including CRDs and clinical scientists.

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

Support and input preparation of internal governance milestones

Oversee and contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities

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 CRDs in the project, Global Project Head, The PV Rep, Regulatory

Provide expertise in the fields of clinical development, autoimmunity and solid organ transplantation

Lead/Act as a mentor for CRDs and Clinical Scientists on a same project/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 CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams.

**Clinical development plan strategies:**

Clinical strategy: Develop and assess clinical scenarios in alignment with GPH

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

Collaborate with CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates 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 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

Engage and collaborate with internal and external partners, regulators, and experts

**Execution of clinical development and studies activities**

Lead and oversee study implementation and remediate study issues

Review and validate the clinical study report and key results memos

Oversee and is accountable for study related clinical activities

Develop the abbreviated protocol

Review and validate the 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 report

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 operation team during the clinical feasibility

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

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

Answer to medical questions raised by EC/IRBs, sites

**Contribution to regulatory and safety documents and meetings:** Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project. Oversee and is accountable for clinical input in key regulatory documents : Review and/or contribute in the 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

**Clinical expertise, scientific data evaluation and authorship:**

Act as a TA level expert/referent in the field of autoimmunity and solid organ transplantation.

Evaluates relevant medical literature and status from competitive products

Support the planning of and participates to advisory board meetings

Participate and author manuscripts and abstracts

Establish and maintains appropriate collaborations with knowledge experts

**Experience**

Clinical development in the field of autoimmunity and solid organ transplantation

Understanding of pharmaceutical product development and life cycle management gained through ~10 years of development and medical experience

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 and 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): 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.

**Pursue** **_progress_** **, discover** **_extraordinary_**

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