NEUROSCIENCE MEDICAL DIRECTOR, MEDICAL AFFAIRS
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:
Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety
(risk minimization activities / safety surveillance activities).
Works closely with sales, marketing and commercial teams to provide strategic
medical input into core brand (product) strategies, and to support medical/marketing activities (promotional material generation/product
launches) and market access.
Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and
credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for
assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
· In cooperation with affiliate / Area Medical teams, Marketing, RA, Clinical and other functional areas, provides leadership, oversight
and support for assigned products/projects
· Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports.
· Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies.
May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to Abbott conduct on clinical studies.
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
NB: All clinical research / development activities for products under development, and for post approval commitments such as regulatory
agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.
· Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
· 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.
· Responsible for understanding the regulatory requirements related to the clinical studies and global drug development andaccountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
· May act as medical/scientific leader for projects within an area or across several area
· May represent the medical function to the GPT for medical affairs 'activities.
· May assist in 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 lead cross functional sub teams responsible for discrete projects within the therapeutic area (individual publications or study collaborations)
· Initiate research projects and drive them to completion, resulting in high quality publications
Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in
an academic or hospital environment. Completion of residency and/or fellowship is preferred.
Minimum Experience / Training Required
Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of
experience is preferred.
Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy.
Ability to run a clinical study or medical affairs team independently with little supervision. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of
Expert knowledge in a relevant therapeutic specialty. Ability to interact externally and internally to support global business
Must possess excellent oral and written English communication skills. Ex-Us: At least one further major international language is
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 50 % of the Time
AbbVie - 15 months ago