Medical Director, Medical Affairs

Summary

Join AbbVie's Global Medical Affairs team as a GMA leader responsible for developing and overseeing the execution of Companion Diagnostics (CDx) strategies within Oncology. You will lead the development and implementation of diagnostic strategies for individual oncology assets, ensuring optimal launch planning. This role requires collaboration with cross-functional teams, including clinical development and precision medicine, to address evidence and educational gaps. You will educate AbbVie's medical teams on the CDx pipeline and develop educational materials. The ideal candidate possesses significant experience in clinical trials, medical affairs, and oncology, with a strong understanding of regulatory requirements. AbbVie offers a comprehensive benefits package.

Requirements

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D)
• Relevant therapeutic specialty in an academic or hospital environment preferred
• Minimum of 5 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
• Must possess strong leadership skills, ability to influence without authority in cross-functional teams, ability to prioritize effectively, effectively enable coaching, mentoring and conflict resolution
• Prior US specific experience with a companion diagnostic or complementary diagnostic preferably in oncology space is a must
• Prior experience with US specific testing landscape stakeholders including diagnostic partners, academic and community pathologists, oncologists with precision medicine expertise and reference laboratory stakeholders is a must
• Ability to run a clinical study independently with little supervision
• Ability to interact externally and internally to support global business strategy
• Must possess excellent oral and written English communication skills
• Advanced Degree in related science field, (e.g. MS Pharm, PharmD, MD)
• 10+ years of work experience in the pharmaceutical industry and drug development
• 5+ years management experience or position requiring ability to influence cross-functionally
• 5+ years of significant leadership experience required to manage multifunctional responsibilities preferred
• High degree of empathy for the patient and implements tactics that ultimately impact quality of patient care and access to medicines
• Motivational approach, open to new ideas and the ability to connect the dots within and across groups and functions
• Proven leadership skills to form and implement cross-functional matrix teams.  Ability to model performance management leadership behaviors related to the management level
• Strong credibility and ability to establish and maintain productive relationships with a variety of audiences, including government regulators, the scientific community in both academic and private sector environment and other key stakeholders
• Possesses an array of influencing skills with high emotional intelligence and interpersonal savvy. Can lead and inspire teams inside and outside of own organization to deliver on business priorities
• Works across the matrix proactively, partnering with people across functional and geographical boundaries while driving to an outcome.  Co-creates strategy with other functions. Gets the team and cross-functional stakeholders energized about the best solution for the broader AbbVie. Manages relationships adeptly
• Demonstrated organizational and administrative skills; able to independently manage workload, set personal and team priorities and adjust as needed
• Role model of strong interpersonal and teambuilding skills; able to create a shared vision and productively manage conflict between team members with diverse interpersonal styles; able to deliver effective coaching and feedback. Remains calm and effective despite challenging situations, complexity, multiple priorities, and ambiguity

Responsibilities

• Develop and coordinate the overarching CDx strategy across multiple early oncology assets to ensure optimal launch planning of our assets
• Lead the development and implementation of diagnostic strategies for individual assets
• Serve as a key member and content expert in the Pipeline Commercialization Model. Serve as a key member of the Asset Strategy Teams and Integrated Evidence Teams to shape the development and early launch planning of our companion diagnostics for various assets and indications across the oncology pipeline
• Build together with clinical development and precision medicine a comprehensive plan to address the evidence, educational, and standard of care gaps and ensure GMA input into the CDx development strategies. Responsible for understanding the different regulatory requirements across the geographical areas related to clinical studies and accountable for complying with those requirements
• May assist with the scientific review, development, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.  Initiate research projects and drive them to completion, resulting in high quality publications
• Accountable for the education of AbbVie’s medical teams on our CDx pipeline and ensures a smooth transition of GMA activities from the pipeline CDx team to the relevant go-to-market medical affairs CDx launch teams. Responsible for the development of CDx educational materials and educating affiliate office and in-field teams
• Establish and maintain internal and external relationships to facilitate medical activities
• Support drafting regulatory documents for biomarker and CDx to enable prospective analysis in phase 1 and phase 2 studies, including investigational use of candidate companion diagnostic (pre-IVD) assays

Preferred Qualifications

• Completion of residency and/or fellowship is preferred
• 3+ years of experience is preferred
• Medical affairs experience with US focus preferred, but experience in a diagnostic company, reference laboratory or other functions in pharma will be considered
• Experience in executional Medical Affairs roles, regulatory, HEOR, pharmacovigilance or clinical development preferred

Benefits

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