Scientific/Medical Director, Medical Affairs - Hematology

Summary

Join AbbVie as a Scientific/Medical Director in Medical Affairs, contributing specialist medical and scientific expertise to core medical affairs activities. You will play a key role in health-care professional interactions, generating clinical and scientific data, leading educational initiatives, and ensuring patient safety. Collaborate closely with sales, marketing, and commercial teams to provide strategic medical input into brand strategies and support medical affairs and marketing activities. Oversee Medical Affairs-led clinical studies, monitoring study integrity and data interpretation. Provide in-house clinical expertise, coordinating scientific activities with internal stakeholders. Engage with external leaders to gather opinions and incorporate diverse perspectives into clinical development plans. Contribute to the development of marketing materials and medical education programs. This hybrid role offers flexibility with locations in Lake County, IL, Florham Park, NJ, or San Francisco, CA, and remote options are considered.

Requirements

• Advanced Degree PhD or PharmD
• Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required
• Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent
• Knowledge of clinical trial methodology, 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
• Proven leadership skills in a cross-functional global team environment
• Must possess excellent oral and written English communication skills
• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D)
• Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent
• Knowledge of clinical trial methodology, 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
• Proven leadership skills in a 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

Responsibilities

• Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy
• Responsible from 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
• 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 molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects
• May participate in due diligence or other business development activity
• As required by program needs, contributes partnering with Discovery colleagues on the design and implementation of translational strategies
• 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
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia
• Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
• May interact 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
• Serves 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
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities

Preferred Qualifications

• Additional post doctorate experience highly preferred
• 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred
• Experience in hematology and cell therapies highly preferred
• 4+ years of experience is preferred
• Relevant therapeutic specialty in an academic or hospital environment preferred
• Completion of residency and/or fellowship is preferred
• 3+ years of experience is preferred
• Experience in hematology and cell therapies highly preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs