SAGE Therapeutics is seeking an experienced Medical Science Director to join the Medical Science organization and oversee the direction, planning, execution and interpretation of clinical trials/research in CNS and data collection activities. The Medical Science Director will be responsible for the development of strategies that lead to global approvals of our products. The successful candidate will be responsible for creating clinical development plans and for successful execution against those plans.
- Overall accountability for design and implementation of clinical studies, writing clinical protocols and major amendments, design of data collection systems and preparation of final clinical study reports.
- Represents Medical Science on assigned Development Team(s), providing clinical input to overall development planning and implementation, and being responsible for driving and implementing clinical development plans.
- Responsible for directing human clinical trials in CNS, Phases I-IV, for company products under development.
- Coordinates and develops information for reports submitted to regulatory authorities.
- Key contributor to regulatory strategies and author in and/or reviewer of appropriate regulatory documents.
- Engages with KOLs for design of clinical trials and programs.
- Overall accountability to maintain the assessment of benefit/risk.
- Ability to manage external organizations.
Desired Skills and Experience
The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging company that depends on strong links and collaboration with contract research organizations, vendors, clinical sites, academia and nonprofit organizations.
Must excel in a multidisciplinary environment as an integral leader and team member across several project teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Excellent written and verbal communication skills, strong problem solving ability, and attention to detail and quality are critical to success. The individual must be self-motivated, must have a strong work ethic and integrity.
Specific requirements include but are not limited to:
- MD Candidates with training and specialization in Psychiatry/Neurology (board certification) with at least 3 years of CNS clinical development experience are preferred
- PhD with extensive (>10 years) CNS clinical development experience in the pharma/biotech industry with a proven record of representing the Medical Science function and hands-on work and participation in cross-functional teams with the aim of setting up, initiating and conducting clinical trials in CNS (Phases I-IV) will also be considered.
- Familiarization with all aspects of internal functional processes that are crucial for clinical development as well as with external stakeholders in CNS clinical development (e.g., clinical research organizations, vendors, sites, investigators, key opinion leaders and related organizations) is an absolute requirement for the role.
- Strong understanding of technical, business, and regulatory issues.
- Diplomacy and professionalism, ability to build key relationships easily across all levels of the company including leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicines to patients.
- Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
- Able to command respect from peers and subordinates alike, capable of highly-independent work as well as being a team player and role model.
- Able to interface with other functions and their representatives in clinical development teams.
- Proven ability to manage multiple projects, identify and resolve issues.
- Ability to influence without conflict, lead change and manage resistance to change.
- Must be able to solicit information, persuade others and shape outcomes.
- Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and clinical development research organizations and related vendors.
- Excitement about the vision and mission of Sage.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun