Jobs
>
Cambridge

    Clinical Research Director, I&I - Cambridge, United States - Sanofi Group

    Sanofi Group
    Sanofi Group Cambridge, United States

    7 hours ago

    Default job background
    Description

    The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations.

    The CRD is expected to advance scientific and clinical knowledge for immunology in rheumatological or osteoarthritic diseases, incorporate new methodologies, and pro-actively progress study execution.


    MAIN RESPONSIBILITIES

    • Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
    • Advance the CDP through internal management review
    • Leads a clinical sub team to design clinical studies and to create an abbreviated and full clinical study protocol
    • Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
    • Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
    • Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation)
    • Contribute to data review, interpretation and publication of clinical study results
    • Represent Clinical Development at Health Authorities and incorporating advise into development strategy.
    • Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program
    • Align company position on clinical strategy with partner in alliance projects
    • Translate biology into clinic in close collaboration with research and translational medicine
    • Evaluate clinical aspects of business development opportunities as needed
    • Apply high ethical standards and work with integrity

    PROFILE

    Scientific and Technical Expertise

    This position requires a strong scientific and clinical foundation rheumatology or osteoarthritis.

    Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.


    • Be experienced in advancing assets from discovery into clinical development
    • Have experience in novel approaches in translational medicine
    • Have and maintain deep scientific, technical and clinical knowledge in arthritic diseases
    • Demonstrated problem solving skills
    • Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
    • Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome
    • Understand novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods
    • Understand the competitive environment
    • Have established connections within the medical field of their expertise
    • Have a credible publication record
    Basic Qualifications

    • Medical Doctor. Should be board certified or equivalent in dermatology or allergy / immunology
    • Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent
    • More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology
    • Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred
    • Knowledge of drug development preferred
    • Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment
    • Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
    • Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills
    • Fluent in English (verbal and written communication)
    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.

    \#GD-SA

    \#LI-SA

    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.
  • Sanofi Group

    Clinical Research Director I&I

    7 hours ago

    Sanofi Group Cambridge, United States

    **CLINICAL RESEARCH DIRECTOR, I&I** · The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to ...

  • Sanofi Group

    Clinical Research Director, I&I

    1 week ago

    Sanofi Group Cambridge, United States

    **Clinical Research Director - allergy-immunology-dermatology** · 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 emotion ...

  • Sanofi Group

    Clinical Research Director, I&I

    7 hours ago

    Sanofi Group Cambridge, United States

    The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the cli ...

  • Sanofi Group

    Senior Clinical Research Director, I&I

    7 hours ago

    Sanofi Group Cambridge, United States

    **Senior Clinical Research Director, Early Development** · The Senior Clinical Research Director (Sr CRD) supports several early stage programs and manages a team of Clinical Research Directors and Clinical scientists in Early Development I&I. The Sr CRD reports into the Head of ...

  • The Home for Little Wanderers

    Program Director I

    4 days ago

    The Home for Little Wanderers Somerville, United States

    When you join The Home for Little Wanderers, you join a team of professionals dedicated to creating better, brighter futures for kids. · For over 200 years, The Home for Little Wanderers has helped build stable lives and hopeful tomorrows for vulnerable children and their famili ...

  • Sanofi Group

    Clinical Research Director, I&I

    4 weeks ago

    Sanofi Group Cambridge, United States Paid Work

    The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical ope ...

  • St Joseph Health

    Paramedic I

    3 weeks ago

    St Joseph Health Somerville, United States Full time

    Overview · Paramedic I · Provides professional patient care and transportation in accordance with all departmental and St. Joseph Health System operating policies, city and state laws, and applicable contracts. · CHI St. Joseph Health – College Station/Bryan TX Since 1936 CHI S ...

  • RWJ New Brunswick

    Therapist I

    2 weeks ago

    RWJ New Brunswick Somerville, United States Full time

    Job Overview: · RWJBarnabas Health is looking to add a qualified full-time Therapist I in Somerville, NJ · Qualifications: · Required: · Masters degree from an accredited school of Social Work or Counseling degree from an accredited school, PhD from an accredited college or unive ...

  • Randstad

    Medical director i

    2 weeks ago

    Randstad Cambridge, United States

    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large netwo ...

  • HEI Hotels & Resorts

    Cook I

    2 weeks ago

    HEI Hotels & Resorts Boston, United States Regular Full time

    Overview · Prepare food of consistent quality and assist in kitchen functions. · Responsibilities · Prepare food of consistent quality following recipe cards and production and portion standards, per check from servers. · Start food items that are prepared ahead of time, maki ...

  • City of Cambridge

    Plumber I

    2 days ago

    City of Cambridge Cambridge, United States

    ESSENTIAL DUTIES AND RESPONSIBILITIES: · Find out more about this role by reading the information below, then apply to be considered. · Under general supervision: · Installs, removes, and maintains plumbing systems including piping fixtures, fixed appliances, ventilation systems, ...

  • RELX

    Accounting Coordinator I

    3 weeks ago

    RELX Cambridge, United States Full time

    About the Role · Are you a detail-oriented individual with a passion for numbers and a desire to kickstart your career in accounting? We invite you to apply for our Entry-Level Accounting Clerk position · The Accounting Coordinator will report directly to the Manager of Audit and ...

  • Prince William County Schools

    custodian i

    1 week ago

    Prince William County Schools Haymarket, United States

    JOB STATUS:OPENEFFECTIVE:2024-25POSTING DATE:06/05/2024CLOSING DATE:06/13/2024 04:30 PMPOSTING NUMBER: SCHOOL/DEPARTMENT:Battlefield HSLOCATION:Haymarket,VAPOSITION TITLE:CUSTODIAN I - NIGHT (10 MONTHS)/DAY (2 MONTHS)ADDITIONALINFORMATION/REQUIREMENTS:An essential function of thi ...

  • Howard Hughes Medical Institute

    Research Technician I

    1 week ago

    Howard Hughes Medical Institute Cambridge, United States Full time

    HHMI is focused on supporting and moving science forward in a variety of different ways ranging from conducting basic biomedical research, empowering educators, inspiring students, developing the next generation of scientists – even stretching into film and media production. Our ...

  • Mass General Brigham

    Applications Analyst I

    1 week ago

    Mass General Brigham Somerville, United States Regular

    Applications Analyst I - Digital Patient Experience Platforms Description General Summary/ Overview: · At Mass General Brigham Digital, we pride ourselves on our ability to create maximum strategic, clinical, and operational value from established and emergent technologies for ...

  • ARCH SOLAR C&I INC

    C&I Electrician

    1 week ago

    ARCH SOLAR C&I INC Plymouth, United States

    Job Description · Job DescriptionArch Solar C&I, Inc is now accepting applications for Electricians. We are a leader in the Solar industry, and we also provide electrical services to Commercial Customers. · The role of the Electrician is to ensure that the Electrical & Solar team ...

  • Harvard University

    Financial Associate I

    2 weeks ago

    Harvard University Cambridge, United States Full time

    Specific job responsibilities include: · Respond to customer inquiries relating to B2P systems functions navigation and full life cycle of business processes, invoices, payments, holds, kick-outs), PCard, Corporate Card, and reimbursement. · Review, process, and approve day-to-d ...

  • Embassy Boston Logan

    Cook I

    3 weeks ago

    Embassy Boston Logan East Boston, United States

    Job Summary: · Informacin disponible en espaol a continuacin. · A Cook is responsible for preparing all food items based on standardized recipes for the Restaurant/Dining Outlet Cafe Room Service Employee Cafeteria and Banquets while maintaining the highest standards to produce ...

  • Brigham and Women's Hospital

    Cytogenetic Technologist I

    3 days ago

    Brigham and Women's Hospital Boston, United States Full time

    Cytogenetic Technologist I Description Cytogenetic Technologist I · Day Shift · Full Time · G ENERAL SUMMARY/ OVERVIEW STATEMENT : · The BWH Clinical Cytogenetics Laboratory serves all of the Partners HealthCare institutions and affiliates (including MGH and DFCI) and handl ...

  • YMCA of Greater Boston

    Lifeguard I

    1 day ago

    YMCA of Greater Boston East Boston, United States

    Job Description · Job DescriptionDescription12 Hours Per Week - Morning Shift · Under the supervision of the Aquatics Director, this position is responsible for guarding the pool, ensuring the safety of all patrons, enforcing pool rules, and implementing the branch emergency pro ...