Head of Asset in GU, Oncology Clinical Development

About the role

The Head of Asset in GU, Oncology Clinical Development will lead and demonstrate ownership of the design and implementation of multiple clinical development programs. They will oversee project-related education of investigators, study site personnel, and manage one level of Medical and Scientific Directors.

Responsibilities

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan.
• Oversees project-related education of investigators, study site personnel.
• Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists.
• May chair Clinical Strategy Team(s), with responsibility for development of 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, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects.
• Acts as clinical lead and actively solicits opinion leader interactions 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.

Qualifications

• 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.
• Experience in generating, delivering, and disseminating high-quality clinical data.
• Leadership and mentoring experience.
• Expertise in the therapeutic area.
• Ability to interact externally and internally.
• Knowledge of Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and quality standards.

Benefits

Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k).

Pay

$248,000 - $471,500 USD

Schedule

Primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.