Head of Gynecological Oncology Franchise, Clinical Development

Company Description

Abb Vie s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose

Manages 2 levels of Medical and/or Scientific Directors and leads the direction, planning, execution, and interpretation of clinical trials or research activities across several clinical development programs. May lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Acts as the overall leader of the Clinical Research function broadly across programs and disease areas.

As a teacher and mentor, trains and guides both individuals and teams to help them execute effectively and achieve excellence in their assigned tasks.

Responsibilities

• Accountable for reports who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Abb Vie s customers, markets, business operations, and emerging issues. Ensures that staff provides project-related education of investigators, study site personnel, and Abb Vie study staff.
• Trains and lends expertise to staff who serve on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (i.e., Clinical Development Plan) and study deliverables with full consideration of contingencies and alternative approaches. Ensures that staff have capabilities to monitor overall study integrity, study enrollment and timelines.
• Provides or ensures clarity regarding the appropriate level for review and approval 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 two levels of Medical and Scientific Directors (typically 2 to 4 direct; 6 or more overall) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
• In rare circumstances, may lead a CST for an unusually complex, high-priority program. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to ADTs and ALBs, and/or other cross-functional teams and internal stakeholders.
• Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area, directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery colleagues to design and implementation of translational strategies at a disease area and platform level.
• Acts as a senior-level liaison for opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into disease area strategies and Clinical Development Plans as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Actively seeks opportunities to represent Abb Vie at key external meetings and enhance Abb Vie s reputation as an industry leader.
• Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

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. Completion of a residency program strongly…