Position overview:
The role of the ACRD is to:
- 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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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 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:
- 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
- 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
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
- Ability to work within a matrix model
- International/ intercultural working skills
- Open-minded to apply new digital solutions
- 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.
- Medical Doctor (MD) is must, Master and Ph.D. is preferred;
- With 8+ years in pharmaceutical industry; 5+ years in global/clinical drug development; with 5+ years in pharmaceutical industry; 2+ years in global/clinical drug development for aCRD
- Background/clinical physician experience in endocrinology or neurology is preferred.
- Team management skill