Head of Asset in GU, Oncology Clinical Development
BioSpace · North Chicago, IL · 1 wk ago
Business DevelopmentFull-time
About the role
The Head of Asset in GU, Oncology Clinical Development is responsible for managing clinical development programs, overseeing project-related education of investigators, and leading the design and implementation of clinical trials or research activities.
Responsibilities
- Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program)
- Oversees project-related education of investigators, study site personnel
- Makes decisions regarding safety and efficacy of the molecule
- Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists
- Chairs Clinical Strategy Team(s), develops a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches
- Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area
- Acts as clinical lead and interacts with opinion leaders related to the disease area(s)
- Stays abreast of professional information and technology through conferences, medical literature, and other available training
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research
Requirements
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to run a complex clinical research program independently.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
- Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
- Ability to interact externally and internally to support a global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
- Excellent oral and written English communication skills.
- Ability to exercise judgment and address complex problems and create solutions across multiple projects.
Qualifications
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required.
- At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- Ability to run a complex clinical research program independently.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
- Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
- Ability to interact externally and internally to support a global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
- Excellent oral and written English communication skills.
- Ability to exercise judgment and address complex problems and create solutions across multiple projects.
Skills
- Strong medical and scientific principles
- Knowledge of compliance and regulatory requirements
- Understanding of AbbVie's customers, markets, business operations, and emerging issues
- Leadership and mentoring abilities
- Communication and collaboration skills
- Expertise in the therapeutic area
- Ability to stay updated on professional information and technology
Benefits
Not specified
Pay
$248,000 - $471,500 USD
Schedule
Full time