Medical / Scientific Director, US Medical Affairs - Dermatology

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 03, 2018
Ref
1807109
Required Education
Associate Degree
Position Type
Full time
Position Overview:

Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: generation of clinical and scientific data/publications; in-field MSL/strategy and initiatives; healthcare provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); medical educational initiatives, medical review, conducting phase 3b/a studies and safeguarding patient safety. Works closely with Sales, Marketing and HEOR, Market Access and Commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities 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.


Key Responsibilities:
  • Independently contributes to the development of asset/brand strategies
  • Leads development and execution of Medical Affairs plans
  • Ability to design, evaluate and execute various types of research (clinical research, Phase IIIb - IV, epi, EDA, RWE research)
  • Understands the healthcare and bio-pharmaceutical business environment. Able to develop and execute an issue management program to anticipate, plan for and respond to issues
  • Able to lead and influence across functional teams
  • Able to manage brand medical affairs budget including timelines, compliance requirements, etc.
  • Serves as a key internal subject matter expert for the TA. Stays abreast of professional information and technology through conferences, medical literature and other available training to augment expertise in the TA.
  • With support of TA/Head, is able to influence Scientific Publication strategy, co-authors Scientific publications, ensure medical/scientific accuracy of Scientific publication content. Able to advance Scientific Communication Platform.
  • Leadership in Medical Information including: anticipating brand needs (e.g. generation of AMCP/GC Value Dossiers, Medical Information communication content)
  • May contribute to regulatory strategy, labeling and agency interactions. Experience with generating regulatory documents. Stays abreast of key regulatory policies (especially pertinent to human research, scientific exchange and Medical Affairs) as well as regulatory guidance in the TA.
  • Contributes to drug safety/PV and risk management plans. Support and contribute to safety/PV tactics
  • Leadership in Medical Review by providing scientific guidance and issue resolution. May manage and oversee the work of Medical and/or Scientific Directors at Director, Associate and Assistant levels


Position can be hired as a Medical Director or Scientific Director based on level of education and experience

Basic:

For Medical Director:
  • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in pharmaceutical industry environment. Completion of residency and/or fellowship is preferred.
  • 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.
  • 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 protocols. Expert knowledge in a relevant therapeutic specialty
  • Must possess excellent oral and written English communication skills

For Scientific Director:

  • Advanced degree (e.g. PhD, PharmD). Post doctorate experience highly preferred.
  • Ability to provide input and direction to clinical research with appropriate supervision
  • At least 10 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent
  • Ability to oversee a clinical research program of moderate complexity with minimal supervision
  • Ability to perform and bring out the best in others on a cross-functional global team
  • Ability to interact externally and internally to support a global scientific and business strategy
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols
  • Must possess excellent oral and written English communication skills



Equal Opportunity Employer Minorities/Women/Veterans/Disabled