Clinical Development Director - Oncology
Amgen
9 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Clinical Development Director - Oncology (Prostate Cancer)
What You Will Do
- Support clinical development in prostate cancer.
- Support development, execution, and communication of the global scientific/medical evidence plan.
- Support cross-functional/global collaborations to integrate medical, scientific, and commercial input.
- Develop key scientific external relationships with opinion leaders.
- Provide clinical input into safety and regulatory interactions.
- Provide clinical/scientific input during development and execution of clinical trials.
- Interpret clinical trial data.
- Participate in safety assessments and regulatory agency interactions.
- Author CSRs, publications, and regulatory submissions.
- Develop key opinion leaders and deliver scientific presentations at advisory boards, scientific meetings, and external committees (as delegated).
- Identify new clinical research opportunities.
- Support in-licensing/out-licensing and partner relationships.
- Support product lifecycle management for new indications (as directed).
- Provide clinical content input to regulatory and safety interactions/documents and materials for Scientific Affairs and Commercial Organization.
What We Expect Of You
Basic Qualifications:
- MD or DO from an accredited medical school.
- 2+ years of clinical research and/or basic science research.
Preferred Qualifications:
- 5+ years (clinical research/basic science) plus clinical teaching and patient care, particularly in GU oncology (prostate cancer).
- Clinical research experience in biopharmaceutical industry (biotech/pharma/CRO).
- Understanding of scientific method and clinical applications; clinical trial design concepts including biostatistics.
- Sound scientific/clinical judgment; GCP and FDA and EMEA/CHMP knowledge.
- Strong written and oral communication; ability as medical expert in complex environments.
What You Can Expect Of Us (Benefits)
- Total Rewards Plan (eligible): health/welfare plans, retirement/savings, work/life balance, and career development.
Application Instructions
- Apply via careers.amgen.com. Amgen does not have an application deadline; applications are accepted until a sufficient number are received or a candidate is selected.
What You Will Do
- Support clinical development in prostate cancer.
- Support development, execution, and communication of the global scientific/medical evidence plan.
- Support cross-functional/global collaborations to integrate medical, scientific, and commercial input.
- Develop key scientific external relationships with opinion leaders.
- Provide clinical input into safety and regulatory interactions.
- Provide clinical/scientific input during development and execution of clinical trials.
- Interpret clinical trial data.
- Participate in safety assessments and regulatory agency interactions.
- Author CSRs, publications, and regulatory submissions.
- Develop key opinion leaders and deliver scientific presentations at advisory boards, scientific meetings, and external committees (as delegated).
- Identify new clinical research opportunities.
- Support in-licensing/out-licensing and partner relationships.
- Support product lifecycle management for new indications (as directed).
- Provide clinical content input to regulatory and safety interactions/documents and materials for Scientific Affairs and Commercial Organization.
What We Expect Of You
Basic Qualifications:
- MD or DO from an accredited medical school.
- 2+ years of clinical research and/or basic science research.
Preferred Qualifications:
- 5+ years (clinical research/basic science) plus clinical teaching and patient care, particularly in GU oncology (prostate cancer).
- Clinical research experience in biopharmaceutical industry (biotech/pharma/CRO).
- Understanding of scientific method and clinical applications; clinical trial design concepts including biostatistics.
- Sound scientific/clinical judgment; GCP and FDA and EMEA/CHMP knowledge.
- Strong written and oral communication; ability as medical expert in complex environments.
What You Can Expect Of Us (Benefits)
- Total Rewards Plan (eligible): health/welfare plans, retirement/savings, work/life balance, and career development.
Application Instructions
- Apply via careers.amgen.com. Amgen does not have an application deadline; applications are accepted until a sufficient number are received or a candidate is selected.