Head of Asset in GU, Oncology Clinical Development

About the Role

Manages other Medical and/or Scientific Directors and leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.

• 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, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues.
• Oversees project-related education of investigators and study site personnel.
• Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
• Along with Clinical Operations, ensures agreed-upon study enrollment and overall timelines for key deliverables.
• Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for assigned protocols.
• Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists, including hiring, onboarding, mentoring, training, and supporting career development.
• 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.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial, and other functions in these activities.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area.
• Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and 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.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) eligibility.
• Eligibility to participate in long-term incentive programs.