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Job title: Clinical/Medical Development Director (CRD)

• Hiring Manager: Dr. Elisabeth NIEMOELLER
• FR / Gentilly / Campus Val de Bièvre
• permanent position

About the job

Job Purpose
The Clinical Research Director (CRD) aT1D is noted as a primary clinical expert for programs responsible for the design and execution of the clinical development strategy for assigned projects in the Therapeutic Area Diabetes, Cardiovascular and Metabolism (DCVM) focusing on the disease area of aT1D. The CRD aT1D is expected to contribute to the growth of the TA DCVM by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging “the status quo”.

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 and in the TA, Global Project Head, the PV, Regulatory and other key functional representatives.
• 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)
• Responsible for the development and contributes to the Abbreviated Protocol and Protocol for their project
• Responsible for the development and contributes to the clinical part of submission dossier for their projects: Common Technical Document/BLA 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.
• If assigned by the TA head, in charge of the medical/clinical assessment of license-in opportunities

Key responsibilities include:

Leading the clinical development plan strategies:

• Responsible for design and execution of the clinical development strategy and plans (in close cooperation with other members of the team, particularly Senior CRD or Clinical Lead, Regulatory Affairs, PV, Health Economics and the GPH) and clinical sections of Integrated Development Plans (IDP).
• Assessment of the Clinical benefit-risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team.
• Collaborates with other CRDs within the project, and within the TA, 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.
• Raises study or project-level issues to the project head or Principal Clinical Group Leader.
• Contributes to 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.
• Collaborates with external partners, regulators, and diverse internal stakeholders and collaborators.
• Evaluates relevant medical literature and status from competitive products.
• Contributes to life cycle management strategy and activities for the projects whenever appropriate.

Leads, Supports and oversees the execution of clinical development and studies activities

• Responsible for the development and team review of study documents (study ID card, abbreviated protocol, final protocol, protocol amendments, key results preparation, clinical study report).
• Reviews 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)
• Contributes and leads as needed the study specific committees (DMC, steering com, adjudication …) with operational support
• Co-Develop the Statistical analysis Plan (SAP) in collaboration with bio statistics.
• 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
• Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
• Responsible for the elaboration of training material and presentations at the investigator meetings.
• Ensure continuous medical review of aggregated data during clinical trial conduct (Surveillance Report, safety, stat outputs of blinded data, …) in close collaboration 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
• Provide operational expertise to project clinical sub team, as needed.

Responsibilities related to regulatory and safety documents and meetings:

• Review and 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 in collaboration with the pharmacovigilance department (GPE) and clinical pharmacology,
• Ensures clinical data meets all necessary regulatory standards
• Participates in Advisory Committee preparation
• The CRD is the representative for Clinical development (unless a Senior or Group Lead CRD exists)
  • at Global Project team meetings,
  • in meetings with Regulatory Agencies,
  • in Steering Committees (SC) and Data Monitoring Commitees (DMCs),
  • at the Benefit and Risk Assessment Committee,
  • at the Submission Task Force.

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 TA DCV and serves as the clinical advisor to research teams.

Scientific and Technical Expertise:

• Understanding of pharmaceutical product development and life cycle management gained through ~3 years of development and medical experience
• Has and maintains deep scientific, technical and clinical expertise in the therapeutic area T1D.
• Very good expertise in clinical development and methodology of clinical studies.
• Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule(s) of interest
• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitor products
• Maintains visibility within the Therapy therapeutic area to maintain credibility with internal and external stakeholders

About you

Basic Qualifications:

• Medical Doctor (MD) or PhD
• Specialization in Internal Medicine, Diabetology or Endocrinologist with relevant clinical and research experience
• At least 3, preferably more than 5 years in pharmaceutical industry or CRO, previous experience in clinical development

Preferred Qualifications:

• Strong scientific and academic background with deep understanding of aT1D
• Clinical research or pharmaceutical experience in the therapeutic area aT1D
• Knowledge of drug development
• English fluent (spoken and written)

Soft Skills:

• 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.
• Ability to work within a matrix model
• Good networking ability to work in international/ intercultural environment
• Open-minded to apply new digital solutions