AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
Primary Job Function
Oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiates study design. Responsible for directing human clinical trials, phases I – IV for company products under development. Coordinates and develops reporting information for reports submitted to the FDA and Global Regulatory Authorities. Monitors adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements. Leads medical affairs activity related to the generation and dissemination of data supporting overall product scientific and business strategy. Specifically, responsible for direction, planning, and execution of phase IIIb/IV studies, investigator initiated studies, registries, database mining, and HEOR studies. Also responsible for direction, planning and execution of publications, scientific presentation, guideline development, interactions with key physicians, researchers, advocacy groups, academic institutions, government agencies, media and investor relations.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Accountable for the design and management of clinical studies and clinical development plans based on strong medical and scientific principles, knowledge of the regulatory requirements and Abbott’s customers, markets, business operations and emerging issues. Responsibility may extend from early translational development activities to mature product life cycle strategies.
Manages the design, conduct and reporting of clinical trials in line with the development, regulatory and commercial strategy.
Oversees the conduct of clinical trials and is accountable for resolution of scientific issues, interpretation of statistical analyses for clinical significance, PI selection, and scientific reports submitted to the regulatory authorities.
May be responsible for opinion leader development within the therapeutic area.
May interact with and coordinate appropriate scientific activities with internal stakeholders (i.e. commercial, clinial operations, discovery, statistics, regulatory, etc…) as they relate to on-going clinical or medical affairs projects.
May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
Provide scientific 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 or medical literature and acts as a therapeutic area resource.
Represents Abbott at external meetings including investigator meetings, scientific association meetings, etc.
Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.
May contribute Abbott recommendations to regulators during the development of regulatory guidances.
May act as scientific leader for projects within an area.Approval of scientifically accurate marketing materials, advisories, and symposia.
May assist in developing/mentoring clinical science managers within the therapeutic area.May be responsible for the scientific oversight and/or management of the TA investigator-initiated study program.
May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area. Drive Medical Affairs strategies and be a key internal contact/subject matter expert.
With project director, responsible for setting clinical trial and publication strategy to carry out overall program objectives.
With project director, ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
Position Accountability / Scope
Works with limited guidance. Can address complex problems within discipline/project. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.
Advanced education (e.g., PhD, PharmD, PA, NP) highly preferred. Residency or/+ post doc highly preferred.
Minimum Experience / Training Required
Typically 10 yrs experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required. Management and leadership experience at project level, experience with strategic initiatives/issues. Proven leadership skills in a cross-functional team environment. International experience a plus. Ability to interact externally and internally to support global business strategy. Ability to run a clinical study or medical affairs team indepedently with little supervision. 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 communication skills.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
AbbVie - 16 months ago