Clinical Development Director – Early Development Oncology
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Job Description
Clinical Development Director advancing Amgen’s oncology medicines from first-in-human studies through proof-of-concept. Designing trials, reviewing data, and guiding early development teams.
Responsibilities:
- Lead the early phase clinical development of oncology compounds from first-in-human studies through proof-of-concept
- Collaborate on teams to support the design and delivery of early phase clinical trials
- Support protocol development, study start-up, data review, monitoring and analysis activities
- Contribute to the design and implementation of early clinical development strategies for oncology therapeutic candidates
- Contribute to clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions
- Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data
- Contribute to the strategy and use of clinical biomarkers to facilitate drug development
- Collaborate with Precision Medicine, Research, Late Development, Regulatory, Safety and Commercial colleagues
- Contribute to evaluating external licensing or partnering opportunities within oncology therapeutic areas
- Collaborate with external experts to provide biomedical expertise and strategic guidance to oncology early development teams
Requirements:
- MD or DO degree from an accredited medical school
- 2 years of industry or academic clinical research/drug development experience
- Board certification or eligibility in Oncology (preferred)
- Residency training in Oncology and relevant subspecialty (preferred)
- Experience in basic research and/or clinical trial methodology (preferred)
- 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials
- Experience collaborating with pharmaceutical sponsors
- Experience designing, monitoring and implementing clinical trials and interpreting trial results
- Demonstrated leadership qualities and ability to conduct studies as part of a team
- Experience within a matrix environment and contributing to decision-making and alignment to meet challenging timelines
- Publication track record
- Excellent interpersonal and presentation skills
- Ability to communicate effectively with internal stakeholders, external partners and collaborators
- Sponsorship for this role is not guaranteed
Benefits:
- 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
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance
- Financial plans with opportunities to save towards retirement or other goals
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