Medical/Scientific Director, Pipeline - Rheumatology

Job Details

Company Description

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. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

Medical/Scientific Director, Pipeline - Rheumatology:

• Provides specialist medical/scientific strategic and operational input into pipeline related medical affairs activities including but not limited to; medical and scientific strategies for the therapeutic franchise and/or multiple assets/indications, deep therapeutic area and treatment data and insights synthesis, external expert and provider interactions, generation of clinical and scientific data (enhancing therapeutic benefit, unmet medical need and added value to standards of care for patients); internal and external educational initiatives (medical education, data, guidelines and scientific communications and training).
• Develops and maintains professional relationships with External Experts, develops innovative research concepts aligned to evidence gaps for clinical data generation.
• Works cross functionally within the pipeline commercialization matrix to provide strategic medical and scientific leadership and partnership into asset strategies.
• Operates in alignment with AbbVies business code of conduct, policies and all applicable laws and regulations.

Responsibilities:

• Co-chairs and leads as the medical function as Pipeline Medical Affairs Lead (PMAL) within the asset deliverable team framework of the pipeline commercialization strategic (PCS) model.
• Co-leads and partners on the development of multiple asset strategies within the pipeline and strategic governance frameworks.
• Initiates medical affairs activities, generation and dissemination of data supporting the overall pipeline scientific strategy.
• Builds and shapes the Pipeline Scientific Communication Strategy for multiple assets.
• May contribute to the design, analyses, interpretation, and reporting of scientific content related to protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
• Leadership of external Medical Affairs activities such as, but not limited to, advisory boards, congress support, medical education programs, training and symposia.
• May assist with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities such as Investigator Initiated Studies (IIS) and collaborations.
• Leads and coordinates appropriate internal facing scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory etc) including but not limited to evidence gap workshops, scientific platform and narrative, external expert engagement mapping and planning ahead of key scientific meetings/congresses aligned to the Early Medical Functional Plan
• Provides 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.
• Ensures budgets, timelines, compliance requirements are factored into medical affairs programs and scientific activities.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
• Participates in the design and execution of clinical trial safety, product safety and risk management plans. May alsocarry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies.

There is a strong preference for this position to be based in Lake County, IL, however there could be a remote option

Qualifications

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D) or PhD in relevant field. Relevant therapeutic specialty in an academic or hospital environment preferred.
• Non-MD: Minimum of 10 years of clinical development or medical affairs experience in the pharmaceutical industry or academia or equivalent. At least 5 years of experience within the pharmaceutical industry preferred.
• MD: Minimum of 5 years of clinical development or medical affairs experience in the pharmaceutical industry or academia or equivalent. At least 5 years preferred. At least 2 years of experience within the pharmaceutical industry preferred. Completion of residency and/or fellowship is preferred.
• Knowledge of clinical trial methodology with Good Clinical Practice (GCP), data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Ability to run a clinical study independently with little supervision.
• Deep understanding of the clinical research and development process.
• Proven leadership skills in a cross-functional global team environment.
• Ability to interact externally and internally to support global business strategies.
• Must possess excellent oral and written English communication skills.
• Experience working within the specific TA highly preferred

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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