Full-Time

Clinical Research Director

Confirmed live in the last 24 hours

Sanofi

Sanofi

10,001+ employees

Global healthcare company providing pharmaceuticals and vaccines

Biotechnology
Healthcare

Mid, Senior

Cambridge, MA, USA

Position requires onsite presence in Cambridge, MA.

Category
Biology Lab & Research
Biology & Biotech
Required Skills
Risk Management
Data Analysis

You match the following Sanofi's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • 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 methodologies 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
  • Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written)
  • 3 years in pharmaceutical industry or CRO, previous experience in clinical development
  • Moderate computer skills
Responsibilities
  • Responsible for the clinical development plans and 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/or 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
  • Evaluates relevant medical literature and status from competitive products
  • 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
  • Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
  • Provide medical support to clinical operation team during the clinical feasibility
  • 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 medical questions raised by EC/IRBs, sites
  • Develop the clinical study report
  • 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
  • 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 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
  • Ensure clinical data meets all necessary regulatory standards
  • Participates in Advisory Committee preparation
  • Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintain 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
Desired Qualifications
  • International/intercultural working skills
  • Open-minded to apply new digital solutions

Sanofi provides healthcare solutions through its pharmaceutical and biotechnology products, focusing on treatments and vaccines for various medical needs. The company conducts extensive research and development to create new therapies and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medicines, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and strategic partnerships, allowing it to maintain a diverse product pipeline and a global presence. The company's goal is to enhance health outcomes and improve the quality of life for people worldwide.

Company Stage

IPO

Total Funding

$2B

Headquarters

Paris, France

Founded

1973

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Simplify's Take

What believers are saying

  • Tolebrutinib's FDA Breakthrough Therapy designation boosts Sanofi's neurology portfolio.
  • Dupixent's EU approval for young children expands Sanofi's pediatric market.
  • Sanofi's partnership with BrightInsight accelerates digital health solution development.

What critics are saying

  • Liver enzyme elevations in tolebrutinib patients may affect market acceptance.
  • Increased competition in rare diseases from biotech startups challenges Sanofi.
  • Regulatory delays could impact Dupixent's approval for chronic spontaneous urticaria.

What makes Sanofi unique

  • Sanofi's Care4Rare program supports innovative solutions for rare diseases.
  • The MyWay app enhances patient engagement and medication adherence.
  • Sanofi's Muse AI tool optimizes patient recruitment in clinical trials.

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Benefits

Health Insurance

Professional Development Budget

Parental Leave