Medical Director or Scientific Director, Medical Affairs

Summary

Join AbbVie as a Director and provide specialist medical and scientific strategic and operational input into core medical affairs activities. You will be responsible for the design, analysis, interpretation, and reporting of scientific content, overseeing clinical studies, and providing in-house clinical expertise. Collaborate with sales, marketing, and commercial teams to provide strategic medical input into brand strategies. Lead the delivery of medical functional plans and develop innovative research concepts. Drive medical affairs activities and coordinate the training and development of others. This role requires strong leadership skills and excellent communication abilities.

Requirements

• 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
• 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

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 multiple myeloma, 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 clinical and precision medicine 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 lead delivery of medical functional plan, brand plan, and integrated evidence plan
• 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 others
• May lead 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

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

Benefits

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