Scientific Director OR Medical Director, Medical Affairs - EPI (GI Care)

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Job description

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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description
Onsite in Lake County, IL preferred. Will consider remote candidates.

Position title will be based on qualifications listed below.

The Scientific Director for Medical Affairs in GI Care for exocrine pancreatic insufficiency (EPI) provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: evidence generation through execution of clinical trials and real-world analyses (e.g., therapeutic benefit, safety and medical value), HCP and stakeholder interactions (e.g, professional societies, patient & payer groups), educational initiatives, and interpretation of clinical and scientific data for scientific communications. They serve as a core cross-functional Medical partner for key medical affairs strategic deliverables including comprehensive gap assessment, scientific communications platforms, scientific narratives, integrated evidence plans, and medical strategic plans to drive innovation and life cycle management of our medicines.

Responsibilities:

• In collaboration with Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight, and support for assigned indications/projects. Works closely with Brand Teams and relevant cross-functional teams to provide strategic input into core scientific strategy, and to drive Medical Affairs activities and evidence gap closure.
• Lead or provide input into the design, analysis, interpretation, and reporting of scientific and medical data and information across study protocols, Investigator Brochures, Clinical Study Reports, publications/presentations 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. As the SD Study Lead, is responsible for oversight of study enrollment and overall timelines for key deliverables.
• Provides in-house clinical expertise for the assigned assets, disease, and evidence; develops and maintains professional relationships with key opinion leaders; actively participates in relevant asset, development, and pipeline cross-functional teams to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans, evidence-generation, publications, content generation, and protocols.
• Assist in the development of scientifically accurate marketing materials, medical education programs, advisory boards, and symposia, among others. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.

Ensures projects are completed on time, on budget, and in compliance with AbbVies policies and regulatory requirement.

Qualifications
Scientific Director Qualifications

• Advanced Degree PhD, NP/PA, or PharmD. Additional post doctorate experience highly preferred.
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy, design of protocols and study reports.
• Typically, 10+ years of experience in the pharmaceutical industry or equivalent.
• Minimum of 4 years of clinical trials or research management experience in the pharmaceutical industry or academia or equivalent is preferred.
• Ability to collaborate with internal and external stakeholders and investigators for clinical study execution with little supervision.
• Proven leadership skills in a cross-functional team environment.
• Must possess excellent oral and written English communication skills.

Associate Medical Director Qualifications

• Medical Doctorate (MD) or equivalent (DO).
• Minimum of 2 years of Medical Affairs experience in the pharmaceutical industry.
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy, design of protocols and study reports.
• Minimum of 4 years of clinical trials or research management experience in the pharmaceutical industry or academia or equivalent is preferred.
• Ability to collaborate with internal and external stakeholders and investigators for clinical study execution with little supervision.
• Proven leadership skills in a cross-functional team environment.
• 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 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.

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