General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible to set Clinical Pharmacology strategy for clinical development plans across the portfolio and lead the Clinical Pharmacology function. This role includes budgetary responsibility, resource planning and allocation, while providing direction, planning, and execution of clinical pharmacology programs and the interpretation of clinical pharmacology data. The Senior Director Clinical Pharmacology will be accountable for the clinical pharmacology strategies portfolio, clinical development programs and study design, and oversight of the team responsible for clinical pharmacology study synopsis and protocol development in compliance with the clinical development plans. To be successful in this leadership role, the individual will have demonstrated management skills, and 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 the development portfolio, the design and implementation of program-specific clinical pharmacology studies, the writing of clinical study synopses and protocols/major amendments, the design of data collection systems and the preparation of final clinical study reports.
- Oversite and management of Clinical Pharmacology team members, responsible for appropriate allocation and support along with a focus on the growth and development of our team members.
- Ensure Clinical Pharmacology team representation on Clinical Sub Teams, providing clinical pharmacology input to the clinical development plan.
- Represents Medical Science/Clinical Pharmacology on assigned Program Teams and ensure representation on Study Management Teams, providing medical input to program-specific 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, in collaboration with and under the direction of the Drug Safety/Pharmacovigilance Department.
- Ensure preparation of information for reports submitted to regulatory authorities. Responsible for all content in appropriate regulatory documents including clinical pharmacology sections of CTD format documents.
- Monitors adherence to protocols and determines study completion.
- Develops and nurtures effective, positive and productive relationships with investigators and KOLs for the design of clinical pharmacology trials and programs, and with CROs and cross functional teams internally at Sage (Medical Science, Data Science, Clinical Operations, Regulatory, DMPK.)
- Overall responsible for the assessment of benefit/risk with the Medical Science and Drug Safety/Pharmacovigilance teams.
- Ability to manage external organizations.Successful candidate will have demonstrated success working in a fast paced, innovative environment and the ability to 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. Demonstrated 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 abilities and attention to detail and quality are critical to success.
- Specific requirements include but are not limited to:
- Experience, Education and Specialized Knowledge and Skills
- MD, PharmD, or PhD with at least 10 years of bio/pharmaceutical industry drug development experience in clinical pharmacology.
- Established track record of team leadership, with at least 3 years of management experience is preferred.
- Knowledge of Neurology, Anesthesia and/or Psychiatry drug development or relevant clinical experience is strongly preferred.
- Knowledge of 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 lead a team and earn the respect from peers as required 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.
- 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.