Clinical Development Director - Oncology

Join Amgen and help develop treatments for patients with serious illnesses. In this vital role you will support Clinical Development in Prostate cancer.

What You Will Do

• Support the development, execution and communication of the global scientific/medical evidence plan

• Support cross‑functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program

• Support the development of key scientific external relationships with opinion leaders

• Participate and provide 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 presentations 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

What We Expect Of You

We are seeking a clinical development professional with the following qualifications.

Basic Qualifications

• MD or DO degree from an accredited medical school

• At least 2 years of clinical research experience and/or basic science research

Preferred Qualifications

• 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)

• 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 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 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

What You Can Expect Of Us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.

• 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, 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. Refer to the Work Location Type in the job posting to see if this applies.

Equal Opportunity Statement

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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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 accommodation.