Principle Clinical Research Director, I&I

JOB DESCRIPTION

The Principle Clinical Research Director (CRD) is noted as the primary clinical lead for complex priority 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-Class” expert in the respective therapeutic area.

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. 

Leads the clinical development plan strategy

• Supports the project activities by focusing on the strategic clinical approach to the collective program; Responsible for the clinical development plans and clinical sections of integrated development plans (IDP) for the Lead Indication and the program Life Cycle Strategy, including new indications

• Medical /clinical reference in the program, ensuring the medical relevance of the clinical data across all studies with the project

• Represents the program at key regulatory agency meetings as the medical spokesperson; participates in Advisory Committee; Leads the strategy and structure of the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP; Contributes to the clinical part of Common Technical Document for any regulatory submissions and supports registrations, label submissions and modifications

• Establishes Target Product Profile (TPP) and Target Value Proposition (TVP) and contributes to the commercial and market access strategy (in collaboration with respective functions), by providing input on existing clinical needs and approaches to clinical development strategies

• Establishes and maintain appropriate collaborations with knowledge experts; supports the organization of advisory board meetings

• Preparation of documents and presentations for internal and alliance governance meetings

• Evaluates relevant medical literature and status from competitive products

Manages a team of CRDs and Clinical Scientists

• Strong leadership skills; able to manage a team of expert CRDs and Clinical Scientists supporting the collective program

• Leads, supports and oversees the execution of clinical development and studies activities (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Statistical Analysis Plan, Key Results Memo, Clinical Study Report)

• Reviews and validates the clinical sections of the Investigator’s Brochure (IB), CTA, IND, DSUR, DRMP…

• Develops and mentors CRDs; creates a stimulating team spirit

Manages a multi-disciplinary clinical team

• Leads the Sanofi cross-functional clinical team and the Alliance joint clinical team

• Supports the clinical team with key interactions from other functions (i.e. Regulatory, Medical, Pharmacovigilance… and other key functions)

• Key medical / clinical reference for the compound, ensures operational delivery (eg harmonizing study documents, ES, protocols, etc), ensures leadership, builds consensus, coordinates 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. He/she raises study or project-level issues to the Global Project Head and TA Head as relevant

• 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)

Scientific data evaluation and authorship

• Key role in participating and aligning on standardizations and activities in for the Protocol Review Committees

• Participates and authors manuscripts and abstracts

• Contributes 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

EXPERIENCE

• Broad understanding of pharmaceutical product development and life cycle management gained through several years of development and medical experience

• Outstanding understanding of Clinical Study conduct and medical affairs activities (global and local)

• Outstanding expertise in clinical development and methodology of clinical studies

• Demonstrated strong leadership, foster team motivation, ability to influence and drive decisions

• Outstanding 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

• Outstanding intercultural/international working skills

• Open and preferably experienced in digital solutions

MINUMUM LEVEL OF ANY REQUIRED QUALIFICATION

• Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written), certification in pulmonary medicine is a plus

• Several years experience in pharmaceutical industry or CRO, previous experience in clinical development

• Computer skills

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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