Company: SAGE Therapeutics
Posted on: June 12, 2021
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
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
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.
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
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.
EEO is the Law
EEO is the Law - Poster Supplement
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.
Keywords: SAGE Therapeutics, Cambridge , Medical Director, Other , Cambridge, Massachusetts
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