General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible to oversee the direction, planning, and execution of clinical pharmacology programs and the interpretation of clinical pharmacology data. The Director Clinical Pharmacology will be accountable for the clinical pharmacology strategy for assigned development programs and study design, and will be responsible for clinical pharmacology study synopsis and protocol development in compliance with the clinical development plan. To be successful in this role, the individual will be self-motivated, able to work well in cross-functional teams, and must have a strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.
The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging start-up company that depends on strong links and collaboration with contract research organizations, academia and nonprofit organizations.
Roles and Responsibilities
- Overall accountability for the clinical pharmacology strategy for each assigned program, the design and implementation of clinical pharmacology studies, the writing clinical study synopses and protocols/major amendments, the design of data collection systems and the preparation of final clinical study reports.
- Represents Clinical Pharmacology on assigned Clinical Sub Teams, providing clinical pharmacology input to the clinical development plan.
- Represents Medical Science/Clinical Pharmacology on assigned Study Management Teams, providing medical input to overall clinical pharmacology study planning and implementation.
- Responsible for directing human clinical pharmacology trials, Phases I–IV, for company products under development.
- Responsibilities also include adverse event reporting and safety management, under the direction of the Patient Safety Department.
- Coordinates and develops information for reports submitted to regulatory authorities. Authors appropriate regulatory documents including clinical pharmacology sections of CTD format documents.
- Monitors adherence to protocols and determines study completion.
- Develops positive and productive relationships with investigators and KOLs for the design of clinical pharmacology trials and programs, and with CROs and DMPK colleagues internally at Sage.
- Overall responsible for the assessment of benefit/risk with the Medical Science Director and Patient Safety Department.
- Ability to manage external organizations.
Experience, Education and Specialized Knowledge and Skills
Successful candidate must thrive working in a fast paced, innovative environment and remain flexible, proactive, resourceful and efficient in that setting. Must excel in a multidisciplinary environment and provide clinical pharmacology leadership on assigned Clinical Sub Teams and medical leadership within assigned Study Management 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.
Specific requirements include but are not limited to:
- PharmD, Phd with at least two years’ bio/pharmaceutical industry drug development experience in clinical pharmacology
- Knowledge of Neurology, Anesthesia and/or Psychiatry drug development or clinical experience as a Neurologist or Psychiatrist is strongly preferred.
- Knowledge if the drug development process; strong understanding of technical, business, and regulatory issues
- Be a diplomatic professional, ‘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 in a matrixed organization, capable of highly-independent work as well as being a team player and role model; a key ability for success is to interface with clinical operations.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the Company.
- Ability to work independently as well as part of a team environment.
- Proven ability to manage multiple projects, 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 CRO.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.