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    Clinical Development, Senior Director - Los Angeles, United States - Third Rock Ventures

    Third Rock Ventures
    Third Rock Ventures Los Angeles, United States

    1 week ago

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    Description


    A clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases.

    The company is building a pipeline of therapies that target rare and common cardiometabolic diseases. The company's lead program is in Phase 2 clinical development for a number of cardiometabolic indications.

    This soon to launch company is led by a dynamic team of scientists and company builders with deep know-how and experience in cardiometabolic diseases, human genetics and adipocyte biology.

    Reporting the CMO, the Director/Senior Director, Clinical Development will be the clinical and medical strategic lead of one or more products/therapeutic areas, accountable for all applicable early and late clinical projects IND enabling through Ph2).

    The Clinical Development Director will ensure the planning, implementation, managing, and reporting of the applicable pre-clinical and clinical studies in accordance to the product development plan.

    The incumbent will have primary responsibility for providing product development status updates to the R&D Leadership Team.

    The incumbent will support Medical Affairs and R&D Operations teams with medical/clinical oversight and/or guidance on collaborative research programs applicable for one or products for which he/she is accountable.


    JOB RESPONSIBILITIES:
    Product Development

    Lead and strategize the generation and implementation of product development plan (inclusive of target product profile, clinical development plan) for one or more products
    Provide leadership for the R&D team members for the planning and execution of the pre-clinical and clinical programs in accordance with the product development plan (inclusive of target product profile, clinical development plan)
    Ensure that scientific rigor and innovation continues to be integrated into and drives Company's development strategies

    Clinical Trials

    Guide and organize the team members for the planning, implementation, managing, and reporting of clinical trials and programs
    Prepare, review, and approve clinical trial content and documents including synopses and protocols, Investigator Brochures, and clinical study reports
    Review and approve Medical Monitoring Plan, Safety Plans, Protocol Deviation Plans
    Review Statistical Analysis and long term strategy plan shells
    Ensure studies are conducted according to GCPs and organizational SOPs
    Contribute to the preparation of IND/NDA clinical sections
    Serve as medical monitor and representative to multiple vendors and collaborators including CROs, PIs, core laboratories, and other organizations involved in the implementation of a clinical trials
    Work closely with internal team and CRO in execution of trials, and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies
    Work with R&D Operations and/or Finance on the clinical study budget and timelines
    Work/Guide R&D and Regulatory teams on clinical/medical responses to regulatory agency queries, meetings preparations and review of briefing packages
    Review/approve of clinical study entries (clinical trial information and results) for posting to and/or TPRs
    May be expected to represent company at joint development committee as well with global regulatory agencies

    Clinical Study Publication

    Lead the creation, review and approval of abstracts, posters and manuscripts for pre-clinical/clinical studies in support of the publication strategies for assigned brands

    Stakeholder Management

    Provide product development status to Senior R&D Leadership Team
    Provide sound clinical development guidance to key stakeholders across organization

    Business Development

    Function as the Clinical Lead for business development activities by evaluating new product potential


    SKILLS AND ABILITIES:
    Experience in pharmaceutical research, specifically exposure to the IND/NDA/BLA approval process, Phase 1 and 2 clinical research
    The incumbent should have an MD or MD/Ph.
    D and at least 5+ years of directly related biotechnology/pharmaceutical clinical research experience
    The incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information
    Professionalism, critical thinking, evidence-based reasoning, and a team-oriented outlook are of the utmost importance
    Proficiency in critical aspects of early and late development required for the job, specifically knowledge of the development path for the therapeutic areas, FDA and ICH regulations, GMP/GLP/GCP
    This position also requires a working knowledge of software packages (e.g., MS Word, MS Excel, MS PowerPoint)
    The ability to work on a team and effectively communicate with a diverse audience are essential
    Excellent communication (written and oral) skills are required
    Demonstrates the ability to analyze complex situations and proactively identify opportunities/issues; effectively solves problems that cross functional boundaries


    WORKING CONDITIONS:
    Prolonged periods of being at a stationary desk or work computer
    Ability to occasionally adjust, handle, or move objects up to 20 pounds
    Ability to assess the accuracy, neatness, and/or thoroughness of the work assigned
    Willingness and interest to work on site in our San Francisco office for a minimum of 3 days per week


    We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state, and local law.

    We invite applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

    #J-18808-Ljbffr
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