Senior Medical Director, Immunology 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 provide products and services in our Allergan Aesthetics portfolio.

• Manage the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues.
• Oversee project‑related education of investigators, study site personnel, and Abb Vie study staff.
• Have overall responsibility for oversight of clinical studies, monitoring overall study integrity, and reviewing, interpreting, and communicating accumulating data pertaining to safety and efficacy of the molecule.
• Along with Clinical Operations, be responsible for oversight of study enrollment and overall timelines for key deliverables.
• Assess and report serious adverse events per corporate policy and regulations for assigned protocols.
• Design, analyze, interpret, and report the scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
• May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
• Provide 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 participate in due diligence or other business development activity and, as needed, contribute in partnership with Discovery colleagues to design and implementation of translational strategies.
• 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.
• Act as a clinical interface and actively solicit opinion leader interactions related to the molecule and disease area; partner with Medical Affairs, Commercial and other functions as required, consistent with corporate policies.
• Stay abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area.
• Understand the regulatory requirements related to the clinical studies and global drug development and be accountable for complying with those requirements.
• Serve as a clinical representative for key regulatory discussions.
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards in conducting research.

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non‑U.S. equivalent of an 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 desirable.
• At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or an equivalent setting.
• 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 the development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills.

• The compensation range described below is a range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting, based on the job grade for this position. Individual compensation paid within this range will depend on many factors, including geographic location, and may ultimately be more or less than the posted range.
• We offer a comprehensive package of benefits, including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
• This job is eligible to participate in our short‑term incentive programs.

Abb Vie 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.

US & Puerto Rico applicants seeking a reasonable accommodation can learn more at the Abb Vie website.