Clinical Development Director - Oncology

Regulatory Jobs; United States; On-site; USD 275,000 - 372,000; Full time

Job summary

Amgen is seeking a Clinical Development Director - Oncology to lead the clinical development program in prostate cancer. You will shape the global scientific and medical evidence plan, coordinate cross‑functional input, and build key external relationships with opinion leaders.

You will contribute to safety and regulatory discussions, interpret trial data, and guide trial design with strong medical judgment. A MD/DO and 2+ years of clinical research experience are required.

Qualifications

• MD or DO degree from an accredited medical school.
• 2 years of clinical research experience and/or basic science research.

Responsibilities

• Support the development, execution and communication of the global scientific/medical evidence plan.
• Support cross-functional and global collaborations to integrate input into the development program.
• Support development of key scientific external relationships with opinion leaders.
• Participate in safety assessments and regulatory interactions.
• Author CSRs, publications and regulatory submissions.
• Identify new clinical research opportunities.
• Support in-licensing/out-licensing activities and partner relationships.

Skills

Clinical research

Biopharma experience

Regulatory knowledge

Medical expertise

Communication skills

Education

MD/DO degree

Job description

Career Category

Clinical

Job Description

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Development Director - Oncology

What you will do

Let’s do this. Let’s change the world. In this vital role you will support Clinical Development in Prostate cancer.

• Supporting the development, execution and communication of the global scientific/medical evidence plan
• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Supporting the development of key scientific external relationships with opinion leaders
• Participating and providing 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 presentation 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 all different, yet we all use our unique contributions to serve patients. The clinical development professional we seek has these qualifications.

Basic Qualifications

MD or DO degree from an accredited medical school
AND
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 company)
• 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 Good Clinical Practices (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 both 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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.

Salary Range

274,788.85USD -371,773.15USD

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.