General Scope and Summary
SAGE Therapeutics is seeking a Senior Medical Science Director to oversee the direction, planning, execution and interpretation of clinical trials/research and data collection activities. The Sr. 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. To be successful in this role, the individual will be self-motivated, must have a strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.
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, academia and nonprofit organizations.
Roles and Responsibilities
- 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 medical input to overall development planning and implementation.
- Leads Clinical Sub Teams, responsible for driving and implementing clinical development plans.
- Responsible for directing human clinical trials, Phases I - IV, for company products under development.
- Responsibilities also include adverse event reporting and safety responsibilities.
- Coordinates and develops information for reports submitted to regulatory authorities.
- Key contributor to regulatory strategies and authors and/or reviews 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.
Experience, Education and Specialized Knowledge and Skills
The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. 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.
Specific requirements include but are not limited to:
- Medical degree and 10+ years broad bio/pharmaceutical industry experience in drug development – Phase 1 through launch. NDA experience strongly preferred.
- Knowledge of Neurology, Anesthesia and/or Psychiatry.
- Orphan drug/fast-track experience desirable.
- Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
- Diplomacy and professionalism, ‘clicking’ easily with the company and 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 clinical operations.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the Company.
- Ability to work independently as well as part of a team environment.
- Proven ability to manage multiple projects, identify and resolve issues.
- Ability to influence without authority, 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 CROs.
- 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.