Purpose:

The Executive Medical Director provides specialist medical/scientific strategic and operational input into core medical affairs activities within the designated therapeutic area, particularly ovarian cancer. This will include healthcare professional/provider interactions; generation of clinical and scientific data; educational initiatives; safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provides scientific and technical support for assigned products; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Brand Teams and helps develop medical affairs strategies for assigned products. Develops innovative research concepts for clinical data generation; provide relevant scientific and technical training.

Responsibilities:

• Establishes and approves scientific methods for hypotheses, rationale, design of study protocols and their reports across different products.

• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.

• Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events and Serious Adverse Events if assigned to Abb Vie conduct on clinical studies.

• All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.

• Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development. Identifies training needs.

• Interacts with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia.

• Oversees scientific/medical education of investigators, clinical monitors, and Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.

• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. Represents Abb Vie at external meetings including investigator meetings, scientific association meetings, etc.

• Assists with the scientific review, development, approval, execution and communication of affiliate/area medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function.

• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. Works independently. Can address complex problems within discipline or across several projects. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors.

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred . National license to practice medicine preferred..)

• Minimum of 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent. 7+ years of experience is preferred.

• Proven leadership skills in a cross-functional team environment. People management experience preferred.

• Ability to run a clinical program or medical affairs team(s) independently with little supervision.

• Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.

• Expert knowledge in a relevant therapeutic specialty. Experience in a senior role in a TA preferred.

• Must have an understanding of the Pharmacovigilance practices for Clinical Development programs.

• Must have an in-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must possess excellent oral and written English communication skills. Ability to interact externally and internally to support business strategy. International experience is a plus.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the 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 we may ultimately pay more or less than the posted range. This range may be modified in the future.
• 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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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 only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About Abb Vie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.