Medical Director, Global Dermatology Global Medical Affairs

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
May 08, 2018
Ref
1801095
Required Education
Doctorate/PHD/MD
Position Type
Full time
Provides specialist medical/scientific strategic and operational input into core medical affairs activities in the Global Dermatology Therapeutic Area such as: health-care professional interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety.


Works closely with cross functional team members in the GBT and ADT to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provide scientific and technical support for Derm product launch; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in Derm Global Brand Teams, Asset Development team and helps develop medical affairs strategies for the assigned assets in Dermatology ; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.


Job Description:

  • Lead and develop asset/brand strategy and leading the development & execution of Medical Affairs Plans in Dermatology TA.
  • Lead GMA product Launch, and develop plan and tools to support the launch including global total gap assessment and scientific platform development.
  • Gain and share insights within GMA and the TA on the evolving healthcare and bio-pharmaceutical environment
  • Contribute to AbbVie's overall research platform and data generation cross-GMA. Design, evaluate & execute various types of research (clinical research, Phase IIIb-IV, epi, EDA, RWE Research)
  • Support 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.
  • Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc 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.
  • Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Support 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.
  • Influence and actively contribute to regulatory strategy, labeling and agency interactions. Generate regulatory documents. Stay abreast of key regulatory policies as well as regulatory guidance in the Derm therapeutic area.
  • Lead and influence cross functional teams, including those with senior cross functional members, to achieve set objectives in a timely fashion and escalate decisions as appropriate
  • Engage with key external stakeholders in Dermatology to appropriately shape the understanding of the disease state and clinical practice. Represents Abbvie at external meetings (e.g. Sci or Professional Associations, EADV, AAD, EDF, etc..).
  • Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to Derm therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a Derm therapeutic area resource.
  • Educate TA, GMA and other cross-functional teams on the Medical Affairs Compliance Environment (from a position of expertise)
  • Can address complex problems, 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.
Technical Competencies:

  • Therapeutic Area Technical Expertise (Dermatology/Immunology).
  • Management Skills, Communication Skills, Total Quality Management (TQM) Skills.
  • Problem/Conflict Solving Ability. Priority Setting.
Qualifications:

  • Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general.
  • Knowledge of the scientific methods applied to clinical research and the current legislative/regulatory controls.
  • Solid knowledge of the pharmaceutical environment and excellent skills to set stake-holders relationship.
  • Strong medical affairs expertise; ability to work well cross-functionally. Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
  • Fluency with written and spoken English.
Required core competencies/attributes:

  • Adaptability: Maintains effectiveness when experiencing major changes in work tasks or the work environment, adjusts effectively to work within new work structures, processes, requirements, or cultures. Considers change or new situations as opportunities for learning and growth. Perseveres when encountering adversity. When confronted with a problem or crisis considers alternatives and then takes timely action. Effectively prioritizes work tasks.
  • Initiative: Takes prompt action to accomplish objectives, is proactive. Maintains a strong focus on internal and/or external customers. Continuously monitors relevant information, key issues and/or trends. Proactively seeks feedback and adapts behavior to improve performance. Demonstrates a willingness to learn new aspects of the business.
  • Innovation: Generates innovative solutions in work situations, tries different and novel ways to deal with work problems and opportunities. Uses best practice and benchmark data to increase organizational performance. Identifies opportunities to improve efficiencies and reduce costs.
  • Integrity: Firmly adheres to codes of conduct and ethical principles. Exhibits honesty. Presents information accurately and completely. Keeps commitments to work colleagues and customers. Acknowledges and responds constructively to failure and mistakes.
  • Teamwork & Collaboration: Works effectively and cooperatively with others; establishes and maintains good working relationships with internal and external partners to facilitate the accomplishment of work goals. Helps others achieve shared goals. Demonstrates a willingness to listen without interrupting. Open to diverse and different ideas.
  • Education Requirements: M.D. degree (or its equivalent) with appropriate post graduate training in therapeutic area of relevance to the responsibility (suitably qualified scientists may also be considered with PhD or PharmD).
Equal Opportunity Employer Minorities/Women/Veterans/Disabled