Senior Scientific Director / Executive Medical Director, Medical Affairs – Hematology

About the role

Lake County, IL preferred; Florham Park, NJ, Waltham, MA, San Francisco, CA, and Irvine, CA will also be considered.

Responsibilities

• Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).
• Works closely with marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to drive medical/marketing activities (promotional material generation/product launches) and market access.
• Drives GMA input into and influences the development of asset strategy.
• Provides specialist medical insights, and executes on data generation, communication, and expert engagement activities as deliverables to relevant Asset Strategy Teams (ASTs) for both early and late stage development program including leading or contributing to: comprehensive gap assessment, development of Scientific Communication Platform, development of integrated evidence plans to support launch readiness.
• Leads external stakeholder interactions (Payers, Patients, Prescribers, and Providers).
• Drives scientific communication initiatives (both internal and external medical education, data, guidelines and value proposition).
• Works in collaborations/alliances and supports the various associated governances.
• Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
• Develops innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally.
• Drives medical affairs Epcoritamab and Ibrutinib activities and generation and dissemination of data supporting overall product scientific and business strategy.
• Captures and disseminates data from clinical trials and other sources to support medical affairs activities.
• Coordinates induction, mentoring, training, and development of team members.
• Provides scientific and technical support for assigned assets; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Asset, Development and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy.
• Works cross functionally to lead the development of the strategy.
• Reviews, assesses and reports applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
• Leads the development and execution of advisory boards, scientific and medical education programs.
• Provides scientific/medical education to all relevant internal stakeholders 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 specific therapeutic area resource.
• Initiate research projects and drive them to completion, resulting in high quality publications.
• Lead functional and cross functional teams responsible for discrete projects within the specific therapeutic area (data analysis, expert engagement, individual publications, study collaborations).
• Represents Medical Affairs in due diligence activities for the acquisition of assets aligned with the Disease Area Strategy.
• Safeguards patient safety (risk minimization activities / safety surveillance activities).
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.

Qualifications

• 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.

Skills

• Strong scientific background in a relevant therapeutic specialty.
• Experience in a senior role in a TA preferred.
• Excellent oral and written English communication skills.
• Ability to interact externally and internally to support global business strategy.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• People leadership experience preferred.

Benefits

Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Pay

Compensation range based on job grade.

Schedule

Hybrid schedule of Tues-Thurs in office is required.