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Job

Director, Clinical Development

  • Location

    San Diego or San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Cooper Treibel

  • Contact email:

    c.treibel@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 days ago

  • Expiry date:

    2022-08-22

  • Startdate:

    ASAP

Company Description

This company is a clinical stage biotech company focused on developing novel therapies for severe and life threatening autoimmune and inflammatory diseases.

 

Job Summary

This position will be responsible for directing and contributing to cross-functional clinical research activities, focusing on advancing clinical development programs through all phases of development, including contributing to and participating in regulatory submissions and meetings. This role will be accountable for matrix deliverables carried by team projects within the broader clinical development team (internal/external). Examples of matrix team projects include the design, execution, and reporting of clinical trials, analysis of clinical and safety data at the conclusion of each phase of development, contributing to medical affairs activities including KOL identification and management, advisory boards, and medical communication activities including publications, pharmacovigilance activities, and translational research and commercial projects. Key measures of success will include the ability to contribute, coordinate and harmonize clinical development activities with multiple functional groups with the intent of delivering success by defining clear strategic development plans, communicating timelines and deliverables, and ensuring appropriate accountabilities.

 

Key Responsibilities

  • Primary responsibility to support and drive the execution of clinical research activities for relevant programs. Develop trial protocols in collaboration with all functions, vendors and consultants. Be a key contributor on clinical study teams.
  • Provides clinical and scientific input in regulatory documents: INDs, BLAs/NDAs, PSURs; Annual Safety Reports, Core Data Sheets, Investigator's Brochures, Clinical Study Reports, Clinical Summaries and Clinical Overviews (risk/benefit evaluation).
  • Collaborates with clinical, regulatory, and commercial organizations to execute on lifecycle plans, including new indications.
  • Potential to manage and mentor other clinical development team professionals.

 

Qualifications

  • PhD or PharmD Required
  • Proven track record of exemplary leadership, high standards of professionalism and successful management of complex drug development projects within an integrated, high performing biotechnology or specialty pharmaceutical organization.
  • In addition, this person will have previously served a minimum of 2-4 years in an integrative team leadership role where they worked with specific drug development projects, within clinical drug development and safety, global registration, and post-approval activities.