Senior Medical/Scientific Director, Medical Affairs, Hematology - Blastic Plasmacytoid Dendritic Cell Neoplasm

Summary

Join AbbVie's Medical Affairs team as a Senior Director, contributing specialist medical and scientific expertise to core medical affairs activities. Collaborate with cross-functional teams to provide strategic medical input into brand strategies and drive medical/marketing activities. Lead external stakeholder interactions and scientific communication initiatives. Execute on data generation, communication, and expert engagement activities for both early and late-stage development programs. Provide leadership and support for assigned indications/projects, and lead the development and execution of advisory boards and medical education programs. Maintain professional relationships with key opinion leaders and represent Medical Affairs in due diligence activities. This role requires a strong understanding of clinical trial methodology, regulatory requirements, and pharmacovigilance practices.

Requirements

• 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
• Minimum of 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent
• Proven leadership skills in a cross-functional team environment
• 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
• 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
• Advanced Degree PhD or PharmD
• Typically, 15 years’ experience in the pharmaceutical industry or equivalent
• Minimum of 10 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent
• Proven leadership skills in a cross-functional global team environment
• Ability to interact externally and internally to support global business strategy
• Expert knowledge in a relevant therapeutic specialty
• Ability to interact externally and internally to support global business strategy
• Proven ability to run a clinical study or medical affairs cross-functional team independently
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
• Must possess excellent oral and written English communication skills

Responsibilities

• In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory, HEOR and other functional areas, provides leadership, oversight, and support for assigned indications/projects
• Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and is responsible for executing medical activities for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
• Medical affairs team lead for individual contributors responsible for the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia
• Medical affairs lead of various product and governances responsible for the medical functional plan, brand plan, and integrated evidence plan
• 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 activities and generation and dissemination of data supporting overall product scientific and business strategy
• 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
• Provides input in design and execution of Phase II-III trial programs including target population and endpoint selection aligned with TPP
• Works cross functionally to lead the development of the BPDCN 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 Migraine and 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
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
• Works independently
• Can address complex problems within discipline or across several projects
• Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions
• Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors

Preferred Qualifications

• Completion of residency and/or fellowship is preferred
• National license to practice medicine preferred.)
• 7+ years of experience is preferred
• People management experience preferred
• Experience in a senior role in a TA preferred
• International experience is a plus
• Additional post doctorate experience highly preferred
• People leadership experience preferred

Benefits

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