The Medical Sciences Director will be responsible for designing and executing early development clinical trials and leading the Evidence generation teams.
Effectively network with internal and external opinion leaders.
Design and implement innovative early clinical development strategy for neuroscience.
Lead the preparation of clinical development plans and clinical study protocols, and contribute to informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions.
Review and evaluate clinical study safety, efficacy, and pharmacokinetic data.
Contribute to the development and use of clinical biomarkers to facilitate drug development.
Actively collaborate with Amgen Neuroscience Global Development and Discovery Research, regulatory, and commercial colleagues.
Collaborate with external experts to provide biomedical expertise and strategic guidance to neuroscience early development teams.
Contribute to in-licensing evaluations and due-diligence activities.
Doctorate degree and 4 years of scientific experience
Master's degree and 7 years of scientific experience
Bachelor's degree and 9 years of scientific experience
Graduate of a recognized school of medicine with an M.D. degree or equivalent.
3+ years of Drug Development experience in the pharmaceutical industry and/or substantial clinical trial 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.
Board certification or eligible.
Experience in early clinical trials.
Experience in basic research and clinical trial methodology.
Experience with use of wearable sensors/digital health/mobile health applications in a clinical setting.
Publication track record.
Excellent interpersonal and presentation skills. Communicate effectively with internal stakeholders, as well as, external partners and collaborators.