The role of the CRD is to:
- 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
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
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Key responsibilities include:
Leading the clinical development plan strategies:
- 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
Lead, Support and oversee the execution of clinical development and studies activities
- Review and validate the final protocol and protocol amendments
- Review the ICF WSI and TDF
- 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)
- Lead the study specific committees (IDMC, steering com, adjudication ...) with operational support
- Co-Develop the SAP in collaboration with bio stats
- Responsible for key results preparation
- Develop the clinical study report
- Take on as necessary the Associate CRD role:
- Develop the abbreviated protocol
- Develop the final protocol and protocol amendments
- Medical support to clinical operation team during the clinical feasibility
- Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
- Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
- Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
- Participate in the elaboration of training material and presentations at the investigator meetings
- Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, ...) with operational support, bio stat and GSO
- Answer to medical questions raised by EC/IRBs, sites
- Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
- Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:
- feasibility managers for feasibility preparation and validation of feasibility results
- Medical Writers to develop, review and finalize WSIs, study protocols and reports
- Clinical Scientists, Medical review team and Coding
- Pharmacovigilance (GSO, CME)
- CTOMs, Biostatisticians
- CSU medical advisors for the best knowledge of the study, compound, protocol
- 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
Responsibilities related to regulatory and safety documents and meetings:
- Review and/or contribute in the clinical section of the Investigator's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
- Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
- Ensures clinical data meets all necessary regulatory standards
- Participates in Advisory Committee preparation
Scientific Data evaluation and authorship: Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintains appropriate collaborations with knowledge experts Contribute 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
- Understanding of pharmaceutical product development and life cycle management
- 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
- Very good 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
China Specific Requirements:
- To lead China clinical development plan with solid knowledge and comprehensive experience on drug development, by engaging CN and global multi-function teams; to represent CN team in GPT and governance review.
- To be liaison between Sanofi R&D and related medical societies in CN, to lead CN KOL interaction for project and study related issues.
- To provide clinical direction in CN submission strategy, to lead CN specific clinical topics, documents and dossiers in CTA, NDA and HA interaction.
- To provide timely clinical support on study level issues in GSD to ensure the success of CN development strategy.
- To be the primary contact for GPH and GCL for China strategy and issue discussion.
Minimum Level of any Required Qualifications:
- Medical Doctor (MD) is must, Master and Ph.D. is preferred; with 8+ years in pharmaceutical industry; 5+ years in global/clinical drug development; 3+ years in project management:
- Clinical Physician experience in relevant TA is a plus.
- Team management skill;