Associate Medical Affairs Director
Scorpion Therapeutics, Rancho Santa Fe, CA, United States
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
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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
#J-18808-Ljbffr