The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for dermatology 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.
The role of the Senior CRD is to:
- 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.
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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
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
- Interact with other CRDs in the project, Principal CRD, Global Project Head, The PV Rep, Regulatory and other key functional reps
Main responsibilities:
- Internal Governance: Preparation of Documents and Presentations for Internal Governance Meetings
- Provide oversight and strategic direction to CRD in preparation for and during health authority meetings
- 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 products
About you
- Medical Doctor (MD) required: GP or specialist (dermatology experience optimal), English fluent (spoken and written)
- Proven experience in the pharmaceutical industry or CRO, previous experience in clinical development
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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