General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for a highly visible role that is responsible for medical affairs strategic execution and real-life data generation activities. The position is responsible for supporting the integration of patient, family and healthcare provider unmet needs into medical affairs strategy and orchestration of subsequent Medical Affairs activities. They will be a member of the Medical, Legal and Regulatory (MLR) review committee and the Promotional Material Review Committee (PMRC) providing content expertise and medical review to a wide range of materials. They will work closely with the Global Program Medical Directors, Medical Sciences, Clinical Operations and Health Economics teams to develop and execute medical affairs activity in support of clinical development and lifecycle needs.
Role and Responsibilities
Member of MLR and PMRC- working with internal stakeholders at the initiation, creation and review of educational and promotional materials. Provide medical expertise in review and approval of external resources, communication and publications to ensure medical accuracy, objectivity and fair-balance
- Provide medical expertise in support of developing content (slides, websites, standard response letters) for medical communications and education to advance disease state and clinical understanding.
- Provide medical expertise in development and alignment of disease, program and portfolio level medical communications in collaboration with global program medical directors and communication team.
- Participate with Global Program MDs and cross-functional team to perform post-hoc data analyses and identify opportunities to address clinical data gaps
- Develop foundational materials and support training for regional and medical field teams.
- Work closely with study teams to support clinical trial site recruitment and patient enrollment.
- Plan and execute advisory boards with healthcare providers (physicians, nurses, nurse practitioners, pharmacists, etc.) to collect needed clinical insights to inform medical strategy.
- Work with clinical development and HEOR teams to support inclusion of appropriate trial endpoints and outcome measures to inform physicians and payers.
- Represent Medical Affairs on cross-functional internal teams.
- Collaborate with the Preclinical, Clinical Development, and Medical Affairs teams to translate clinical insights and data gaps into medical strategy.
- Manage and regularly meet with a thought leader network to support the successful execution of Medical Affairs tactics.
- Represent Sage at various scientific and clinical congress meetings.
- Cultivate partnerships with cross-functional partners such as clinical development, translational science, discovery, patient safety, regulatory, operations, program management, and marketing to provide medical leadership in support of relevant therapeutic initiatives.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
This position requires an MD, DO, PhD or PharmD with high preference for prior industry experience in CNS/psychiatry/mood disorders/ or movement disorders.
- Prior experience in helping to develop medical strategic and tactical plans in support of drug launch is highly preferred
- Minimum of 8 years of combined pharmaceutical industry and/or academic/clinical medicine expertise.
- Must possess excellent communication skills, relationship building capabilities, and proven ability to influence decision-making without authority.
- Must be willing and able to travel and occasionally work with Medical Science Liaison to meet with HCPs/KOLs as necessary.
- Is able to perceive non-obvious opportunities by connecting the dots between existing knowledge, new data, and HCP unmet needs in real time
- Must be highly perceptive, socially intelligent and intuitive
- Leadership skills, including a passion for working within multiple teams and proven ability to achieve results in a matrix organization.
- Is seen as a scientifically credible leader and collaborative partner to internal and external stakeholders.
- Consistently and systematically collaborates with internal stakeholders to plan approach to bring meaningful value to healthcare providers
- Ability to manage many complex projects in parallel, structuring the actions of many people toward share outcomes
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in a rapidly growing and changing environment
- Ability to flexibly tailor effective communication to multiple social styles
- Must embrace Sage’s core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun