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Clinical Development Director – Oncology
AmgenClinical Development Director supporting prostate cancer development and execution at Amgen. Collaborating globally and developing scientific/medical evidence plans with key opinion leaders.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support Clinical Development in Prostate cancer
- Supporting the development, execution and communication of the global scientific/medical evidence plan
- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
- Supporting the development of key scientific external relationships with opinion leaders
- Participating and providing clinical input into safety and regulatory interactions
- Provide clinical/scientific input during the development and execution of clinical trials
- Interpret clinical trial data
- Participate in safety assessments
- Participate in interactions with regulatory agencies
- Author CSRs, publications and regulatory submissions
- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader
- Identify new clinical research opportunities
- Support in-licensing and out-licensing activities and partner relationships
- Support product lifecycle management for new indications as directed by Global Development Leader
- Provide clinical content input to: Regulatory interactions and documents, Safety interactions and documents, Materials to be used in Scientific Affairs, Materials to be used by the Commercial Organization
Requirements
What you’ll need- MD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science research
- 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in GU Oncology (prostate cancer)
- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics
- Sound scientific and clinical judgment
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- Demonstrated ability as a medical expert in a complex matrix environment
- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchclinical trial designbiostatisticssafety assessmentsregulatory submissionsscientific presentationsclinical data interpretationGood Clinical Practices (GCP)FDA regulationsEMEA/CHMP regulations
Soft Skills
effective communicationscientific judgmentproblem-solvingcollaborationleadershipinterpersonal skillsorganizational skillsclinical expertisepresentation skillscritical thinking
Certifications
MDDO