Executive Medical Director, Head of Translational Medicine
At SAGE Therapeutics, Translational Medicine encompasses creative clinical study designs and endpoints that address questions such as whether there is evidence of target engagement, whether efficacy readouts can be enhanced using biomarkers, and whether patient enrichment strategies are likely to be effective; in addition, Translational Medicine investigates mechanisms of action, potential new indications, and novel endpoints. The tools employed by Translational Medicine include biomarkers, imaging, translational endpoints from pharmacology, and wearable digital technology. Translational Medicine often employs modelled data to address unanswered questions. A critical aspect of this role is liaison with Translational Science.
Sage is seeking an Executive Medical Director to head the Translational Medicine function at Sage. Key aspects of this role include the championing and oversight of the work of Translational Medicine across all stages of drug development, working with cross-functional clinical development teams to develop clinical trial designs and/or include appropriate endpoints in existing clinical studies to achieve the goals of Translational Medicine and address the identified unmet needs of the programs. In addition, the incumbent will be accountable for the design and execution (with the clinical operations team) of exploratory studies in Translational Medicine that fall outside the main development remit of the Program Teams. This role will build on the strong relationship with Translational Science at Sage, which collaboration will deliver a Translational Plan for each program.
Overall accountability for the appropriate inclusion of Translational Medicine endpoints in clinical trials and pertaining to those Translational Medicine endpoints and outputs: supervising the writing of those aspects of clinical protocols and major amendments; overseeing the design of data collection systems; leading the interpretation of data and their presentation in clinical study reports and publications; accountable for the design and execution of exploratory studies in Translational Medicine that fall outside the main development remit of Program Teams.
Leads and inspires the Translational Medicine team at Sage.
Responsible for providing Translational Medicine representation on Program Teams and Clinical Sub Teams, providing Translational Medicine input to overall development planning and implementation.
Coordinates with cross-functional colleagues to ensure that appropriate Translational Medicine data are included in models and interpreted appropriately to address regulatory and medical affairs questions and for inclusion in documents submitted to regulatory authorities.
Engages with key opinion leaders and external organizations to optimize the design of Translational Medicine endpoints and clinical studies.
Desired Skills and Experience
The successful candidate must thrive working in a fast-paced, innovative, multidisciplinary environment as an integral leader and team member across several cross-functional teams. Additionally, building successful internal and external links and collaborations, including with contract research organizations, academia and nonprofit organizations, and the ability to analyze complex issues to develop relevant and realistic plans and recommendations will be key to success. A strong work ethic, excellent problem-solving ability, and attention to detail and quality are critical to success
Medical degree and at least 5+ years of broad bio/pharmaceutical industry experience in drug development, coupled with at least 3+ years of experience of translational medicine.
Knowledge of Neurology and/or Psychiatry; previous work in translational medicine related to brain health, highly desirable. Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
Well connected to an external network of relevant and highly credible advisors. 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
Diplomacy and professionalism with excellent stakeholder management skills and with the ability to contribute to the corporate goals of becoming a leader in CNS disorders and bringing medicines to patients.
Highly motivated, decisive, and results-oriented individual who is proactive, resourceful, and efficient 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. Proven ability to manage multiple projects, and efficiently identify and resolve issues.
Able to effectively interface with all other disciplines to build relationships and influence decision-making, while managing to tight timelines. Outstanding verbal and written communication skills, allowing for an open and effective dialogue throughout SAGE.
Ability to influence without authority, lead change and manage resistance to change. Must be able to solicit information, persuade others and shape outcomes.
Excitement about the vision and mission of SAGE and embrace the SAGE core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
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