Sage Therapeutics Medical Director in Cambridge, Massachusetts
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role in the Late Development team at Sage. In this role the Medical Director will take the lead on study design and oversee the planning and execution of clinical trials aligned with the Late clinical development plan.
To be successful in this role, the individual must be self-motivated, able to work well with cross-functional teams and external collaborators, be able to influence decision-making, and be able to operate within pre-specified timelines. 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 develop positive collaborations with contract research organizations, academic institutions, and nonprofit organizations.
Overall responsible for the study design of clinical trials in Late Development on assigned programs, leading on the preparation of clinical study synopses and being a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports.
Represents Medical Science Late on assigned Study Management Teams, providing medical science input to overall clinical study planning and execution according to GCP and Sage’s Quality System. Establishes excellent cross functional collaborations with other functions on Study Management Teams to contribute to data analysis plans and takes the lead on the interpretation of clinical trial data.
Responsible for providing or supervising medical monitoring activities for all human clinical trials in Late Development. This includes supporting adverse event reporting and safety management, under the direction of the DSPV function. Contributes to the assessment of benefit/risk. Monitors adherence to protocols and assists in the investigation of protocol deviations.
Develops positive and productive relationships with investigators and external organizations and experts to optimize study design and executions.
Provides medical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents.
Desired Skills and Experience
The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient in that setting. Must excel in a multidisciplinary environment as an integral leader and provide medical science leadership within assigned 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.
Medical degree and 1+ years broad bio/pharmaceutical industry experience in drug development or equivalent.
Knowledge of Neurology and/or Psychiatry.
Knowledge and understanding of the drug development process including technical, business, and regulatory issues.
IND Experience strongly preferred
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 effectively interface with clinical operations, regulatory, and other disciplines.
Excellent verbal and written skills, allowing for open and effective dialogue throughout the Company.
Proven ability to manage multiple projects, and proactively 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.
Number of Openings:
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All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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