Amgen

Clinical Research Medical Director - Oncology (AMG 757)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Apr 16, 2021
Ref
R-112643
Required Education
Doctorate/PHD/MD
Position Type
Full time
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Clinical Research Medical Director - Oncology

Live

What you will do

Let's do this. Let's change the world. Amgen's Global Development team is looking for a Clinical Research Medical Director within Oncology in Thousand Oaks, CA.

Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms - Bispecific T Cell Engagers (BiTE®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules - across many targets and more than a dozen tumor types.

In this vital role the Clinical Research Medical Director - Oncology will contribute to the development of overall program clinical development strategy, evidence generation plan (EGP), and execution of program level activities; lead the design and development of clinical study protocols; and serve as a member of the Clinical Study Team - Leadership Team (CST-LT) to provide strategic oversite and execution of clinical trials.

Responsibilities include:

Provide medical and scientific leadership for design of clinical studies (traditional & innovative) and contribute to trial execution from Phase 2 through life cycle management
  • Collaborate with internal stakeholders and external scientific community such as investigators, key opinion leaders (KOL), etc., as it relates to clinical study design, execution, and results communication.
  • Lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP).
  • Serve as a member of the CST-LT, provide medical and strategic oversight to the study execution.
  • Monitor, analyze, and interpret clinical study data


As a Global Development Representative
  • Responsible for development of Clinical Development Plan for Ph2 and beyond
  • Contribute to TPP and GPS development
  • Contribute to discussions and decision on long-cycle time activities (AC in Ph2, PRO, device, patient voice, TDM, companion diagnostics)
  • Create development options and present to GDRC, FSC
  • Interface with TA leadership and extended team to develop options
  • Interface with CfDA, CfOR, CPMS, etc to bring innovative later dev options


Contribute to the development of overall program clinical strategy, EGP, and program level activities
  • Identify and evaluate new clinical research opportunities
  • Contribute to the development of program clinical development strategy and lifecycle management strategies
  • Participate in interactions with regulatory agencies
  • Provide clinical contribution to regulatory submissions, safety documents, and reimbursement related documents
  • Develop KOL network and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader (GDL)
  • Support review of Investigator Sponsored Studies (ISS) proposals
  • Provide support to regional and local Amgen sponsored clinical studies, as necessary


Support due diligence for business development activities
  • Represent Global Development TA to review available confidential clinical data for a given asset/program
  • In partnership with Commercial and Business Development, champion generation of TPPs (target product profiles) for assets/program under review
  • Propose GANTT clinical development timelines


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is an excellent communicator with these qualifications.

Basic qualifications:
  • MD degree from an accredited medical school OR PhD
  • AND completion of an accredited medical or surgical residency
  • OR clinical experience in either an accredited academic setting or private practice (including hospital based) setting


Preferred qualifications:
  • MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent
  • Thoracic oncology experience preferred
  • Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
  • Previous management experience


Preferred knowledge:
  • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
  • In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
  • Medical knowledge in the relevant therapeutic area
  • Sound scientific and clinical judgment
  • Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
  • Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
  • Understanding of new drug commercialization and business practices
  • Understanding of resourcing and budgeting


Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.