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    Sr. Manager, Clinical Science - Cambridge, United States - The Steely Group

    The Steely Group
    The Steely Group Cambridge, United States

    3 weeks ago

    Default job background
    Description
    Posted:

    09/22/2023


    Employment Type:
    Direct Hire


    Job Category:
    Operations and Development

    Job Number:

    3668
    Job Description

    Reporting to the Director, Clinical Science, the purpose of the

    Senior Manager, Clinical Science

    role is to utilize the clinical development strategy to determine the efficacy and safety of candidate drug products in clinical development based on the interpretation of trial results.



    Responsibilities:

    Contributes to the development of the clinical development plan for the designated product/indication in collaboration with Project Leaders and the Medical Directors.

    Leads and/or contributes to the development of core clinical documents (e.g., clinical protocol synopsis, clinical protocol, TLFs, committee charters and clinical study report), ensuring they are written in accordance with pharmaceutical industry practices and regulatory guidelines.

    Ensures clinical data being collected are aligned with strategic objectives and regulatory reporting requirements.
    Monitors and evaluates clinical data as a basis for the development and design of the clinical drug program/portfolio.

    Remains current on scientific developments, trends and innovative practices that may impact the clinical development organization and the work that the members individually and collectively perform.

    Contributes to the selection of clinical outcome measures to be assessed in clinical studies
    Applies lessons learned from other trials to subsequent clinical trial activities.
    Collaborates with the Medical Director(s), clinical operations, data science, and pharmacovigilance to support program operations
    Conduct reviews of the clinical study data and collaborate on the overall data quality plan.

    To optimize clinical protocols and development plans, performs reviews of regulatory guidance/guidelines, medical literature and new technologies; seeks input from various R&D functions.

    Suggests alternate study designs to address study objectives and improve quality and timeliness
    Facilitates continuous learning and knowledge transfer throughout the project lifecycle.
    Supports project team training of study protocols
    Contributes to process improvement within clinical development
    Selects and liaises with extramural consultants, such as Data Safety Monitoring Board and Steering Committees.
    Builds and maintains relationships with external investigators and key opinion leaders.

    Serves as the scientific point-of-contact for questions associated with an assigned study(s) or program(s) from internal functions, such as clinical operations, or externally (e.g.

    , study sites, vendors)


    Requirements:
    Bachelors degree in Life Sciences or equivalent; advanced degree, such as masters in science, PhD or PharmD is preferred.

    Knowledge of International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and other guidelines.

    Strong data analysis and problem-solving skills.
    Excellent communication and presentation skills.

    Ability to interact with internal team members and external partners to effectively to inform on the objectives and endpoints of a study and rationale for the study procedures and their timing.

    Strong organizational skills to ensure that necessary data collection and documentation is accomplished for the required analysis and interpretation of clinical trial results.

    This role requires the incumbent to travel up to 30% of the time.


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