Note: The job is a remote job and is open to candidates in USA. Amgen is a biotechnology company focused on developing innovative medicines for serious illnesses across oncology and other therapeutic areas. The Clinical Development Director will lead early-phase oncology clinical development from first-in-human studies through proof-of-concept, supporting trial design, protocol development, study execution, data review, and collaboration with internal and external stakeholders.
Responsibilities
- Contribute to the design and implementation of the early clinical development strategy for oncology therapeutic candidates
- Contribute to the preparation of 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
- Actively collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety and Commercial colleagues
- Contribute to the evaluation of external licensing or partnering opportunities within the oncology therapeutic areas
- Collaborate with external experts to provide biomedical expertise and strategic guidance to oncology early development teams
Skills
- MD or DO degree from an accredited medical school
- 2 years of industry or academic clinical research/drug development experience
- Board certification or eligible (Oncology)
- Residency training in Oncology and relevant subspecialty
- Experience in basic research and/or clinical trial methodology
- 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 in designing, monitoring and implementing clinical trials and interpreting trial results
- Demonstrated leadership qualities; capable of conducting studies as part of a team
- Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines
- Publication track record
- Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators
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, and flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
Company Overview
Company H1B Sponsorship