Clinical Research Medical Director, Dermatology

at  Amgen

Job Description

KNOWLEDGE:

• In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
• In-depth understanding of and demonstrated success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development especially Ph2/3 registrational 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
• Prior experience of regulatory interactions, authoring filing IND or BLA experience
• Understanding of new drug commercialization and business practices
• Understanding of resourcing and budgeting

BASIC QUALIFICATIONS:

MD or DO degree from an accredited medical school

PREFERRED QUALIFICATIONS:

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.
• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
• Involved in filing activities as part of the moving the program through the development lifecycle.
• Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
• Previous management experience of clinical development professionals

WHAT YOU WILL DO

Let’s do this. Let’s change the world. The Inflammation Therapeutic Area within Global Development is rapidly growing and in this vital role you will have an opportunity to shape this Therapeutic Area. This role will report directly to the Global Development Lead for a program. The position is US - Remote.

RESPONSIBILITIES:

• Serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s).
• Provide oversight of LCM clinical development with input on global strategy
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s)
• Participate and provide clinical input into safety and regulatory interactions.
• Interpret and communicate clinical trial data.
• Author/review 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 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
• Approximate 10% travel may be required.
• This is a potential managerial role, successful prior experience seeking and developing talent is a plus.