General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible to oversee the direction, planning, and execution of clinical trials and the interpretation of clinical data. The Medical Scientist will be responsible for study design, synopsis and protocol development in alignment with clinical development plans. To be successful in this role, the individual will be self-motivated, able to work well with cross-functional teams and external collaborators, be able to influence decision-making, while managing to time-lines designed for timely delivery of study results. . The individual is expected to possess outstanding communication skills (both verbal and written), a strong work ethic, and a high degree of professional integrity. The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment that emphasizes collaboration with contract research organizations, academic institutions, and nonprofit organizations.
Roles and Responsibilities
- Overall responsibility for design and implementation of EXM clinical studies, writing clinical study synopses and protocols/major amendments, design of data collection systems and preparation of final clinical study reports.
- Contribute to data analysis and integration. Establish cross functional collaborations with Data Science, Translational Science, and Clinical Pharmacology
- Represents EXM on assigned Study Management Teams, providing medical science input to overall clinical study planning and implementation.
- Responsible for directing EXM human clinical trials, Phases I–IV, for company products under development.
- Supports adverse event reporting and safety management, under the direction of the Patient Safety Department.
- Monitors adherence to protocols and determines study completion.
- Develops positive and productive relationships with investigators and KOLs for the design of clinical trials and programs.
- Ability to manage external organizations.
Experience, Education and Specialized Knowledge and Skills
Successful candidate must thrive working in a fast paced, innovative environment and remain flexible, proactive, resourceful and efficient in that setting. Must excel in a multidisciplinary environment and provide medical science leadership within assigned Study Management Teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is essential. 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:
- Pharmacy doctorate (PharmD) or PhD with at least two years’ bio/pharmaceutical industry clinical research and drug development experience
- Knowledge of Neurology, Anesthesia and/or Psychiatry drug development is strongly preferred.
- Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
- Be a diplomatic professional;, "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 in a matrixed organization, capable of highly-independent work as well as being a team player and role model; a key ability for success is 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 the 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 CRO.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow Through Learning and Change, and Work Fun.
- Excitement about the mission and vision of Sage.