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Sanofi Group Clinical Research Director in Cambridge, Massachusetts

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 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, including selection of new indications

The CRD:

  • Reports to the Clinical Lead

  • 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 (pharmcovigilance, regulatory…)

Key responsibilities include:

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)

  • Responsible for key results preparation

  • 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 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

  • Evaluate relevant medical literature and status from competitive products

  • Evaluate potential new indications for the product, through assessment of the literature, and fit between pathogenesis and the molecular pathway of interest

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

  • 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

  • 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 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 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

  • 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

Minimum Level of any Required Qualifications:

  • Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written), certification in pulmonary medicine is a plus

  • 2 years in pharmaceutical industry or CRO & previous experience in clinical development preferred

  • Computer skills

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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