Scientific Director, Psoriatic Disease Medical Affairs

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey.

The Scientific Director / Senior Medical Director provides specialist medical and scientific leadership for AbbVie's Psoriatic Disease portfolio. This role is accountable for developing and executing Global Medical Affairs strategy, driving scientific excellence across all medical affairs activities (HCP interactions, data generation, educational initiatives, and safeguarding patient safety), and serving as the key internal medical expert for the therapeutic area. This role partners cross-functionally with Commercial, HEOR, Regulatory, Clinical Development, and Market Access teams, while maintaining accountability for compliance, patient safety, and scientific integrity.

Position will be based from our Mettawa, IL headquarters site following a hybrid schedule of 3 days/week in office. Other major U.S. R&D sites may potentially be considered for highly experienced talent (Florham Park, NJ or San Francisco, CA).

Key Responsibilities:

• Initiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, and the Brand Plan. Works closely with Area and Affiliates to ensure consistent global execution of medical strategy. Contributes to the development of HEOR evidence strategies to support value proposition, market access, and payer engagement for the portfolio.
• Responsible as Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responses.
• Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders and leadership as they relate to ongoing clinical projects.
• M.D.s may participate in design and execution of clinical trial safety; scientifically accountable for resolution of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess all Adverse Events (AE’s) and Serious Adverse Events (SAE’s).
• Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; 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 Clinical Development Plans and protocols as appropriate.
• Plans and executes scientifically accurate marketing materials, medical education programs, Medical Advisory Boards, and scientific symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc…) as they relate to on-going medical affairs projects. Serve as the scientific team interface for key regulatory discussions.
• Provide scientific/medical education to investigators, clinical monitors, and Global 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.
• Provides leadership, mentorship, and guidance to junior Medical Affairs colleagues. Fosters a culture of scientific excellence, integrity, and continuous learning within the Medical Affairs team.
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. Responsible for understanding regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements. Ensures all medical affairs activities are conducted in accordance with applicable industry codes, AbbVie SOPs, and global regulatory standards.

Qualifications

Experience Requirements

Scientific Director

• Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
• Typically, 10-15 years of experience in the pharmaceutical industry or related.
• 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.

Senior Medical Director

• Medical Doctorate (M.D.) or equivalent (D.O. or non-US equivalent of M.D.). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship preferred.
• Minimum 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred.

Qualifications:

• Substantial understanding of relevant therapeutic area required. Direct subject matter expertise in psoriatic disease highly preferred.
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Proven leadership skills in cross-functional global team environment
• Ability to interact externally and internally to support global business strategy
• Must possess excellent oral and written English communication skills

Additional Information

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 long-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 employer 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.

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.

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What AbbVie Has to Offer

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.