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Clinical Research Director, Belumosudil

Synthorx

Synthorx

Multiple locations
Posted on Monday, August 28, 2023

Job Summary

The Clinical Research Director (CRD) is the primary clinical expert for one or more clinical studies planned or being conducted within the program. The role requires an independent, well-organized, strategic, operationally focused, resourceful individual with very good emotional intelligence, self-motivated, and with solid analytical skills who is able to to deliver on multiple operational tasks.

The role of the CRD is to:

  • Lead the conduct of the clinical study(ies) under his responsibility at both strategic and operational levels

  • Be responsible of the medical documentation associated with the clinical study(ies) (e.g. protocol, clinical study report, …)

  • Participate to the program life cycle strategy planning, including selection of new indications

The CRD:

  • Reports to the Clinical Lead or Clinical Lead supervisor

  • Interacts with the other CRDs in the project, as well as with the Global Project Head,

  • Collaborates with functions to ensure full strategic and operational alignment (Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance …)

Job duties and responsibilities

Lead the clinical study(ies) strategy in the context of the overall clinical development plan strategy

  • Responsible for the clinical study(ies) plans and corresponding 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 clinical lead, and project head when needed

  • Contribute 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

  • Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators

  • Evaluate relevant medical literature and status from competitive products

Lead, support and oversee the execution of clinical study(ies) activities

  • Develop the abbreviated protocol, the final protocol and protocol amendments and the clinical study report

  • Responsible for key results preparation

  • Contribute to the ICF WSI and TDF development

  • Co-Develop the SAP in collaboration with other CRDs and bio stats

  • Lead the study specific committees (IDMC, steering com, adjudication …) with operational support

  • Provide 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

  • Provide 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

Responsibilities related to regulatory and safety documents and meetings:

  • Review and/or contribute to the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP

  • Contribute to the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP

  • Ensures clinical data meets all necessary regulatory standards

  • Participate 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

Job requirements

  • MD degree or equivalent and trained in Hematology / Oncology with 3+ years of experience in clinical development or in phase 3 trial, experience in the area of hematopoietic stem cell transplantation or cell therapy is desired.

  • Understanding of pharmaceutical product development and life cycle management gained through at least 3 years of experience in pharmaceutical industry or CRO, preferably with experience in clinical development; equivalent experience in academia with established clinical trial programs or have acted as principal investigator are acceptable

  • Ability to communicate effectively and present clearly in cross functional meetings

  • Demonstrated ability to interact productively with and attract top external investigators

  • Demonstrated ability to work with a multifunctional team to achieve project milestones

  • Understanding of and willingness to meet applicable regulatory, quality and compliance standards

  • Fluency in written and spoken English

  • Position can be based in any location with Sanofi office or remote location is possible for the appropriate candidate.

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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