General Scope and Summary
SAGE Therapeutics is seeking an experienced Medical Director to play a key role in the Early Development team at Sage. Working with cross-functional teams and external collaborators, the Medical Director will take a key role in the creation and execution of early clinical development plans and in the development of strategies that will ultimately lead to global approvals of Sage's products.
To be successful in this role, the individual will be a creative, resourceful, integrative thinker who is self-motivated, has a strong work ethic, and operates with a high degree of professional integrity. Additionally, the individual must be able to build relationships and influence decision-making while managing to pre-specified timelines. The candidate will be expected to thrive in the dynamic environment of a successful and growing company and to develop positive collaborations with contract research organizations, academic institutions, and nonprofit organizations.
Roles and Responsibilities
For assigned programs, represent Medical Science on Study Teams as the Study Medical Lead. Accountable and responsible for the medical input in the execution of the development plans prepared by the Program Team and the clinical development plans that underpin them.
For assigned studies, provide medical leadership to the Study Management Team of the Clinical Sub Team, providing medical science input to overall clinical study planning and implementation according to GCP and Sage's Quality System; in this role, provide medical oversight for clinical trials according to SOPs.
For assigned programs, responsible with the Program Medical Lead for the study design of clinical trials in Early Development, leading on the preparation of clinical study synopses and being a contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical data, and the preparation of final clinical study reports. Engage with external experts and organizations as needed to achieve these aims.
Serve as a key contributor to regulatory strategies and author and/or review appropriate regulatory documents.
Accountable and responsible for the ongoing assessment of benefit/risk, including support of adverse event reporting and safety management under the direction of the DSPV function.
Education, Experience and Specialized Knowledge and Skills
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 of broad bio/pharmaceutical industry experience in drug development – Phase 1 through launch.
Experience in Neurology and/or Psychiatry.
Knowledge of the drug development process, as well as 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 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, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
Equal Opportunity Employer. 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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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.#LI-Remote
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