Senior Medical Director, Medical Science

General Scope and Summary 

SAGE Therapeutics is seeking an experienced Senior Medical Director, Medical Science to play a key role in the clinical development team at Sage.  The incumbent will take a leadership role in the creation and execution of clinical development plans for assigned programs, as well as providing leadership in the design, execution, and interpretation of clinical studies and development 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 a dynamic environment and to develop positive collaborations with contract research organizations, academic institutions, and nonprofit organizations.

Roles and Responsibilities

• For assigned programs, represents Medical Science on the Program Team as the Program Medical Lead.  Accountable and responsible for the medical science input to the integrated development plan prepared by the Program Team and to the clinical development plan that underpins it.

• For assigned programs, provides medical science leadership to the Clinical Development Team.  Accountable and responsible for the creation and execution of the clinical development plan.

• For assigned programs, accountable for the study design of clinical trials, 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.  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.

• For assigned programs and working with the appropriate Medical Director, is responsible for the ongoing assessment of benefit/risk including support of adverse event reporting and safety management, under the direction of the DSPV function.

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 in that setting.  Must excel in a multidisciplinary environment as an integral leader and team player, provide medical science leadership within assigned teams, and navigate the Sage organization at all levels to achieve Sage’s goals.  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.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

• MD, preferably with a neurology or psychiatry specialization.  PhD in neuroscience desirable.

• Requires 3-5 years’ experience in clinical research in the bio/pharmaceutical industry.  Early phase clinical research experience is desirable.

• Experience in Psychiatry and/or Neurology indications highly preferred.

Desired Skills and Experience

• 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 adapt to evolving situations.

• 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, Forge New Pathways.

Employment Type:

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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.