San Diego, CA
Competitive Base Salary, Bonus, and Compensation Package
4 months ago
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.
- 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.
- 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.
- 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 firstname.lastname@example.org.