Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Medical Director

  • Location

    San Diego, CA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive Base Salary, Bonus, and Compensation Package

  • Contact:

    Emily Mato

  • Contact email:

    e.mato@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-03-28

  • Startdate:

    ASAP

MEDICAL DIRECTOR

Exciting opportunity to join the Clinical Development team in an industry leading Southern California-based oncology drug development company. With their a people-first culture and innovative clinical platform, this company is attracting the top talent in today’s market.

RESPONSIBILITIES

  • Lead global oncology clinical trials as primary medical monitor for assigned studies.
  • Respond to all site inquiries regarding eligibility, enrollment, safety, and patient management.
  • Ensure that all assigned studies comply with company SOPs, company clinical development plan, GCP/ICH, FDA requirements, and industry regulations.
  • Identify and select study sites.
  • Develop and maintain relationships with site investigators. Respond to investigator inquiries for all assigned studies and sites.
  • Collaborate closely with internal and external stakeholders. Prepare slides, presentations, and required documents for internal and external meetings. Prepare abstracts and posters for scientific meetings.
  • Assist in production of clinical sections of regulatory documents.
  • Produce clinical protocols, informed consent documents, investigator's brochures, and safety management plans in compliance with company/industry regulations and good clinical practices.
  • Review and approve study materials.
  • Clinical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements.
  • Oversee Drug Safety Activities conducted by CRO and vendors, including Serious Adverse Event Case processing, Medical Review, and aggregated report production.

QUALIFICATIONS

  • Medical Doctor (M.D., US accredited).
  • Board Certification in Medical Oncology or Hematology Oncology.
  • 2+ years oncology drug development experience in a pharmaceutical or biotech company.
  • Experience in Phase II - III oncology clinical trials preferred.

SKILLS

  • Demonstrated knowledge of GCP/ICH guidelines and industry regulations.
  • Demonstrated knowledge of IND/NDA process.
  • Strong leadership and communication skills.
  • Strategic thinker with the ability to thrive in a collaborative, fast paced environment.

My team and I are working on a number of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or e.mato@hamlynwilliams.com.