Medical Director/Senior Medical Director, Clinical Development - Specialty

Medical Director

AbbVie'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.

Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities include:

• Managing the design and implementation of one or more clinical development programs.
• Overseeing project-related education of investigators, study site personnel, and AbbVie study staff.
• Having overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to the safety and efficacy of the molecule.
• Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
• May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
• Providing in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
• May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
• Acting as a clinical interface and actively soliciting opinion leader interactions related to the molecule and disease area.
• Staying 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 the clinical studies and global drug development and accountable for complying with those requirements.
• Ensuring adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Medical Director 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. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a clinical research program of moderate complexity with minimal supervision.
• Ability to perform and bring out the best in others on a cross-functional global team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• 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.
• Must possess excellent oral and written English communication skills.

Senior Medical Director 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. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 5 years (7 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 through influence.
• 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.
• Must possess excellent oral and written English communication skills.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.