Therapeutic Area Lead, Global Medical Affairs (Hematology)

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
Mar 23, 2018
Ref
1800481
Required Education
Doctorate/PHD/MD
Position Type
Full time
Global Medical Affairs (GMA) acts to bridge the gap between drug development and real world medical practice. As an organization, we are responsible for the practical and clinically meaningful data strategy and delivery of information regarding marketed and investigational therapies in order to inform clinical use and transform patient care. We have an exciting opportunity for a Global Therapeutic Area Lead-Hematology, in Global Medical Affairs, based in Lake County, Chicago Area, IL.

The TA Lead-Hematology will lead the Hematology therapeutic area team within Global Medical Affairs to develop and execute the Global Medical Affairs strategy for AbbVie Hematology asset(s) in development and on market.

Key responsibilities Include:

  • Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safe guarding 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 (e.g.), 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.
  • In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.
  • Coordinates training, identifies training needs, and clinical development strategic initiatives in the context of medical affairs.
  • Supervise employees either directly or in a matrixed environment depending on role and level of responsibility.
  • Establishes and approves scientific and medical initiatives that are in alignment with the overall strategic initiatives of global medical affairs.
  • 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 AbbVie 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, Private Investigator selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. 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.
    • Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
  • May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory) as they relate to on-going medical affairs projects.
  • Act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
  • Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information.
  • Keeps a breast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource in Oncology.
  • Represents AbbVie at external meetings including investigator meetings, scientific association meetings, Medical/Clinical Advisory Boards.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
  • Serves as the scientific team interface for key regulatory discussions.
  • May act as medical/scientific leader for several programs within an area.
  • Represent the medical function to the GPT, GCT, GRPT, Asset Teams, and other cross-functional team meetings as needed.
  • Develop scientifically and medically accurate marketing materials, medical education programs, advisories, and symposia.
  • May assist in developing/mentoring junior medical affairs staff.
  • Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
Qualifications

  • Advanced degree (MD, PhD, DO) with relevant therapeutic specialty (Hematology/Oncology) in an academic or hospital environment highly preferred. Relevant therapeutic area clinical experience and/or Medical Affairs in an academic, hospital or pharma environment required.
  • National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr. med or equal) is strongly preferred. Completion of residency and/or fellowship is preferred. Advanced academic qualification is warranted.
  • Typically 8+ years of clinical trials or medical affairs experience in the pharmaceutical or Biotech industry.
  • Proven leadership skills in a cross-functional global team environment.
  • Ability to interact externally and internally to support global business strategy.
  • Ability to run clinical studies 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 protocols.
  • Expert knowledge in a relevant therapeutic specialty (Hematology/Oncology).
  • Ability to interact externally and internally to support global business strategy.
  • Must possess excellent oral and written English communication skills.
  • Must have basic understanding of Pharmacovigilance practices for Clinical Development programs.
  • Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled