Clinical Research Medical Director
3 days ago
At Amgen, we're driven by a shared mission to serve patients living with serious illnesses. As a Clinical Research Medical Director, you'll play a vital role in shaping our Therapeutic Area and contributing to the development of innovative medicines that improve patients' lives.
Key Responsibilities:- Provide therapeutic area expertise in lung cancer and contribute to the development, execution, and communication of the global scientific/medical evidence plan for thoracic oncology.
- Serve as the medical monitor on key clinical trials in lung cancer.
- Conduct medical review of clinical trial data.
- Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program.
- Participate and provide clinical input into safety and regulatory interactions.
- Author CSRs, publications, and regulatory submissions.
- Lead interactions with key opinion leaders and deliver presentations at advisory boards, key scientific meetings, and external committee meetings as delegated by GDL.
- 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 Lead.
- Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization.
We're looking for a leader with a strong background in clinical research and a passion for making a difference in patients' lives. The ideal candidate will have:
- A MD or DO degree from an accredited medical school.
- 2 years of clinical research experience and/or basic science research.
- Preferred qualifications include fellowship training and board certification in Oncology with demonstrated clinical development experience in thoracic oncology.
- Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
- Experience with developing study concepts for clinical development and clinical trial designs with cross-functional input.
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
- Leadership experience/potential as a lung cancer medical expert in a complex matrix environment.
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
- Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path.
As a member of the Amgen team, you'll enjoy a comprehensive 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. You'll also have opportunities for career development, flexible work models, and a competitive salary range.
Apply now to join a team that's dedicated to making a difference in patients' lives.
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