Associate Medical Affairs Director

Role Summary

Responsible for the development of medical affairs strategy, planning, and tactical implementation for all medical affairs functions including publication planning, data generation and communication, KOL interactions, knowledge management, medical education, advisory boards, and cross-functional partnership.

Responsibilities

• Medical Affairs Planning
  • Partner with key cross-functional stakeholders to develop strategic and aligned Medical Affairs Plans for therapeutic areas of interest
  • Assists in communication and represents plans within the organization. Continuously update plans and inform stakeholders of progress
  • Collaboratively develop a fully referenced scientific platform and lexicon supporting the foundational understanding of Neurocrine therapeutic platforms, describing their derivation, MOA, multimodal attributes and potential for treating various disorders with unmet medical need
  • Assist in gaining the endorsement of the platform from internal and external opinion leaders and educate the organization on its content and use
• Data Generation
  • Aid in establishing strategically aligned key areas of interest for IIS, collaborative research agreements and Phase IV clinical trials
  • Direct and design collaborative research and Phase IV clinical trials for assigned area
  • May serve on review committees for review and approval of investigator initiated and medical education grant requests
  • Provide medical input into clinical development and lifecycle management activities
  • Collaborate with Clinical Development to support clinical trials and pipeline programs
• Data Communication
  • Develop and execute strategically aligned publication plans for key therapeutic areas in collaboration with Medical Communications
  • Participate in congress planning including medical education, competitive intelligence
  • Establish working relationships with KOLs and payers to understand the therapeutic landscape, data gaps and areas of educational unmet needs and garner feedback on key programs
  • Scientific and Medical Consultant to Internal Stakeholders, may be asked to consult External Stakeholders
• Serve as Medical/Scientific Subject Matter Expert
  • Provide knowledge and expertise for assigned products including (but not limited to) PRC, health outcomes plans, MSL activities, speaker programs, training, CME grant reviews or other internal key business processes

Qualifications

• Required: PhD and 7+ years of experience with a combination of clinical practice experience and Medical Affairs or related pharmaceutical consulting capacity
• Required: PharmD and 7+ years of experience with a combination of clinical practice experience and Medical Affairs or related pharmaceutical consulting capacity
• Preferred: MD preferred and 2+ years of relevant experience (Preferred experience: Clinical Practice experience in Psychiatry, Neurology or Movement Disorders)
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Strong interpersonal and communication skills as well as strong organizational and team leadership skills
• Able to work independently and prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment
• Effective communicator with good team collaboration skills. Passion for education and addressing unmet medical needs in Psychiatry or Neurology or related area
• Strong knowledge in one of the relevant specialty areas (Neurology, Movement Disorders, Psychiatry or other related field) preferred
• Comprehensive knowledge of Good Clinical Practices (GCP), ICH, ICJME Guidelines, FDA and other international regulatory body requirements
• Experience in proactively engaging internal and external leaders while serving as the medical affairs representative for assigned programs
• Understands the connection of clinical, medical, and business needs
• Knowledge of aligning business and scientific goals and objectives
• Working knowledge of budget development
• Proven project management, and problem-solving skills
• Analytical, problem-solving, and decision-making skills oriented toward quality work
• Strong writing abilities in the scientific or medical field
• Uses professional concepts in developing resolution to critical issues and broad design matters
• Expertise in developing policies and processes