**General Scope and Summary**
SAGE Therapeutics is seeking an experienced (Senior) Medical Director to play a key role in the Early Development Team at Sage. Working with cross-functional teams and external collaborators, the (Senior) Medical Director will take a leadership 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. This role relates to an NMDA asset in Sage's Early Development portfolio.
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.
+ For assigned programs, represents Medical Science on the Program Team as the Program Medical Lead. Accountable and responsible for the medical input to integrated development plans prepared by the Program Team and the clinical development plans that underpin them.
+ For assigned programs, provides medical leadership to the Clinical Sub Team of the Program Team. Accountable and responsible for driving the execution of the clinical development plan.
+ For assigned programs, accountable for the study design of clinical trials in Early Development, 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, interpretation of clinical data, and the preparation of final clinical study reports. Engages with external experts and organizations as needed to achieve these aims.
+ Key contributor to regulatory strategies and authors and/or reviews 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.
**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 3+ years' broad bio/pharmaceutical industry experience in drug development - Phase 1 through launch.
+ NDA and/or MAA experience desirable.
+ Knowledge of Neurology and/or Psychiatry.
+ Deep knowledge and understanding of the drug development process including 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, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
**Number of Openings:**
**#Biotechnology #Careers #ThisIsSage**
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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Protected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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