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.

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

• 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

• 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:
• Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
• 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
• 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 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

• 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

• 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