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Clinical Research Director, Rare Disease and Rare Blood Disorders

Cambridge, Massachusetts,

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Overview

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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Quote

"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

The Clinical Research Director (CRD) is noted as the primary clinical lead for programs. The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

The role of the CRD is to:

  • Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and 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 TA Heads, as relevant and shares relevant information within and beyond Project teams.
    • 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 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
    • Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps

Key responsibilities include:

Leading the clinical development plan strategies:

  • Internal Governance:  Preparation of Documents and Presentations for Internal Governance Meetings
  • Take on as necessary the CRD role:
  • 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

Lead, Support and oversee the execution of clinical development and studies activities

  • Review and validate the clinical study report
  • Take on as necessary the CRD role:
    • Develop the abbreviated protocol
    • Review and validate the final protocol and protocol amendments
    • Review the ICF WSI and TDF
    • Co-Develop the SAP in collaboration with bio stats
    • Responsible for key results preparation
    • Develop the clinical study report
    • 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)
    • Medical support to clinical operation team during the clinical feasibility
    • Review and provide clinical input across different study documents CRF, e-diary, monitoring plan
    • Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with clinical scientist, bio stat and GSO
    • Lead the study specific committees (IDMC, steering com, adjudication …) with operational support
    • Answer to medical questions raised by EC/IRBs, sites

Responsibilities related to regulatory and safety documents and meetings: Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications.

  • 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

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 ~2 years of development and medical experience
  • Experience on clinical development  of Gene therapy programs in RD and RBD , 2 years
  • Excellent Scientific and medical / clinical expertise
  • Excellent expertise in clinical development and methodology of clinical studies
  • Excellent 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
  • Excellent 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)
  • At least 2 years in pharmaceutical industry or CRO, previous experience in clinical development

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.

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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