Clinical Research Director, Neurology

About the Job

The Clinical Research Director (CRD) is noted as the primary clinical expert for programs.  The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

• Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps

• Take on as necessary the Associate CRD role:

  • Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)

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

  • Contribute to the Extended synopsis and Protocol for their project

  • 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

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

• Collaborate with other 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

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

• Contribute in 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

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

• Evaluates relevant medical literature and status from competitive product

• TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs

  • CROs

  • Regulatory affairs

• Collaborates with other 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. He/she raises study or project-level issues to the global project head and clinical lead

• Provide operational expertise to project clinical sub team, as needed

Experience

• Understanding of pharmaceutical product development and life cycle management gained through ~3 years of development and medical experience

• Very good Scientific and medical/clinical expertise

• Very good expertise in clinical development and methodology of clinical studies

• Very good 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

Minimum Level of any Required Qualifications: 

• Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written)

• At least 3 years in pharmaceutical industry or CRO, previous experience in clinical development

• Computer skills

Why Choose Us?

• 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.

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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