General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for a highly visible role that is responsible for leading US medical affairs strategic execution and real-life data generation activities. The position is responsible for integration of patient, family and healthcare provider unmet needs into medical strategy and orchestration of subsequent Medical Affairs activities, including provision of strategic guidance and leadership of potential Phase 3b/4 clinical trial programs, and investigator initiated studies in the US. 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 Program Medical Directors, Medical Sciences, Clinical Operations and Health Economics teams to develop and execute clinical trials in US to support lifecycle data generation needs.
Role and Responsibilities:
- Ensure alignment and execution of the US Medical Affairs data generation, communication and education activities in collaboration with Program MD and US medical affairs team in support of defined program medical objectives.
- Responsible for cultivating 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 in the US.
- Responsible for interacting with various US investigators, KOLs, research institutions, and internal Sage departments to oversee and facilitate Medical Affairs objectives and ensuring the medical and scientific merit of company activities.
- Provides medical oversight and review in support MLR and PMRC process- working with internal stakeholders at the initiation, creation and review of educational and promotional materials.
- Collaborate with the Program MDs, Patient Advocacy, Clinical Development, and Medical Affairs teams to translate US clinical insights and data gaps into overall medical strategy
- Collaborate with HEOR and clinical operations in development and oversight of US specific Phase IV clinical trial protocols for defined lifecycle management and real-world data generation needs.
- Provide medical expertise in review and approval of external resources, communications and publications to ensure medical accuracy, objectivity, fair-balance and alignment with strategic medical objectives.
- Participate with Global Program MDs and cross-functional team to perform post-hoc data analyses and identify opportunities to address clinical data gaps
- Oversee planning and execution of medical advisory boards with US healthcare providers (physicians, nurses, nurse practitioners, pharmacists, etc) to collect needed clinical insights to inform medical strategy.
- Provide medical expertise and guidance developing resources (slides, websites, standard response letters) for medical communications and education to advance disease state and clinical understanding
- Closely collaborate with US Field Medical Affairs team to regularly meet with thought leader network to support the successful execution of Medical Affairs tactics in US.
- Represent Sage at various scientific and clinical congress meetings.
- Key responsibilities will require him/her to interact with other departments including commercial, clinical, safety, legal and regulatory.
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 prior industry experience in CNS/psychiatry/mood disorders/postpartum depression
- Prior experience in helping to develop medical strategic and tactical plans in support of drug launch in US is highly preferred
- 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 meet with HCPs/KOLs in the US 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
Minimum of 8 years of combined pharmaceutical industry and/or academic/clinical medicine expertise.