Global Medical Affairs (GMA) leader accountable for the creation and oversight of the execution of our Biomarker and Companion Diagnostics (CDx) Global Medical Affairs (GMA) objectives across Oncology, Immunology, Eye Care, Specialty, and Neurosciences.
Oversees GMA biomarker and CDx activities ensuring seamless communication and execution on biomarker and CDx strategies.
Provide strategic support to and guidance to the therapeutic area team in developing, aligning, and executing our biomarker and CDx launch strategies supporting the launch of our assets across geographies.
- Develop and coordinate the overarching Biomarker and CDx strategy across multiple programs, assets, and projects in Immunology, Eye Care, Specialty, and Neurosciences to ensure optimal launch of our assets.
- Lead the development and implementation of biomarker and diagnostic strategies for individual projects and/or therapeutic areas.
- Accountable for creation and execution of the companion diagnostic go-to-market strategy and tactics across the different geographical areas.
- 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 launch of our companion diagnostics for various assets and indications across all oncology portfolio even for assets that are managed by other therapeutic area heads.
- 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 development strategies by bringing therapeutic area insights.
- 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 biomarker and CDs pipeline and ensures a smooth transition of GMA activities from the pipeline team to the relevant go-to-market medical affairs teams across the different geographical areas.
- Responsible for the development and execution of affiliate office and in-field team and medical education and educational materials for CDx launch.
- 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.
- Advanced Degree in related science field, (e.g. MS Pharm, PharmD, MD).
- 10+ years of work experience in the pharmaceutical industry and drug development. Experience in executional Medical Affairs roles, regulatory, HEOR, pharmacovigilance or clinical development preferred.
- 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.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
Responsabilidades Principales: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Viaje: Yes, 25 % of the Time
Tipo de trabajo: Experienced