Clinical Lead, I&I

About the Job 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs.

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

• Act as a mentor for other 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). As relevant, 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. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams.

• Take on as necessary the 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 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

Leading the clinical development plan strategies:

• Internal Governance:  Preparation of Documents and Presentations for Internal Governance Meetings

• Take on as necessary the CRD role:

• 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

• Review and validate the clinical study report

• Review the ICF WSI and TDF

  • Co-Develop the SAP in collaboration with bio stats

  • Responsible for key results preparation

  • Develop the 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

Experience

• Excellent Scientific and medical / clinical expertise

• Excellent 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

• 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

Minimum Level of any Required Qualifications: 

• Medical Doctor (MD) preferred: GP or specialist. Rheumatoloty, Dermatology, gastreoenterology are a plus.

• English fluent (spoken and written)

• At least 5 years in pharmaceutical industry or CRO, previous experience in clinical development

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.

#GD-SA
#LI-SA

#vhd
#LI-Onsite