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Job

Director, Clinical Development

  • Location

    San Diego or South San Francisco, CA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Karina Nurmberg

  • Contact email:

    k.nurmberg@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    17 days ago

  • Expiry date:

    2022-07-08

  • Startdate:

    ASAP

Job Summary

This Company is looking for medical leadership to lead the clinical development of novel therapies for severe and life threatening autoimmune and inflammatory diseases. This is a great opportunity for an experienced clinical development professional to take on a role in building and leading a fast moving and nimble development stage company in areas of high unmet need.

The primary objective of this position will be to serve to support the clinical development programs within Clinical Development and have direct contributions across all of the programs while developing the skills to lead a program.

Job Details

  • 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.
  • Involvement in internal process improvement activities such as SOPs or guidance documents, as assigned.
  • Potential to manage and mentor other clinical development team professionals.

Qualifications

  • PhD or PharmD Required
  • It is preferred that the candidate have clinical development experience in areas of autoimmune and inflammatory diseases or hematologic/oncologic disease.
  • 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.
  • 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. 
  • Experience in data analysis and medical evaluation of clinical trial data.
  • Hands on experience on regulatory submissions involving clinical trial data.