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Job

Senior Medical 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 as the lead for a specific clinical development program within Clinical Development and have direct contributions to potentially other programs.

Job Details

  • Primarily responsible for the planning and execution of clinical research activities for relevant programs. Develop the clinical development program and trial protocols in collaboration with all functions, vendors and consultants.
  • Leadership of the cross functional Clinical Development team in collaboration with all functions, as applicable for the agreed upon timelines and budget. Lead medical input for associated programs. Key contributor to monitoring safety and efficacy data in clinical studies and engaging with study investigators.
  • Provides clinical 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 develop lifecycle plans, including new indications. Be involved in Business Development activities and due diligence.
  • Involvement in internal process improvement activities such as SOPs or guidance documents, as assigned.
  • Potential to manage and mentor other clinical development team professionals and oversee medical monitor and safety review support.

Qualifications

  • M.D. required
  • It is preferred that the candidate have clinical development experience in areas of hematology/oncology or rheumatology or other autoimmune and inflammatory diseases
  • 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 3-5 years in an integrative team leadership role where they were tasked with specific drug development projects, within clinical drug development and safety, global registration, and post-approval activities.