General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for influencing the discovery and development of drugs. This role includes the interpretation of clinical pharmacology data. The Associate Director of Clinical Pharmacology will be a major contributor to the clinical pharmacology study synopsis and protocol development in compliance with the clinical development plans. The candidate will also be a key component on study teams, perform PK and PK/PD analyses to support the development of the drug, and standardize processes by developing SOPs to improve efficiency. 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 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 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.
- Perform routine analysis of clinical pharmacology (PK/PD) data from Phase 1-4 clinical studies with minimal supervision.
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK/PD analysis including population PK, PK/PD modeling and simulation, meta-analysis, etc.
- Develops Clinical Pharmacology data analysis plans
- Contributes to developing departmental processes and SOPs
- Represents Clinical Pharmacology on Study Management and Clinical Sub Teams, providing 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.
- Ensures preparation of information for reports submitted to regulatory authorities. Accountable for generating content in appropriate regulatory documents including clinical pharmacology sections of CTD format documents.
- Prepares responses to inquiries from regulatory agencies with supervision.
- 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.)
- Collaborates with colleagues in bioanalytics, biometrics, clinical development, clinical operations, drug metabolism, toxicology, and regulatory affairs for clinical studies
- Ability to manage external organizations.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. 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.
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or a related field or MD or PharmD with at least 5 years of bio/pharmaceutical industry drug development experience.
- Experience using Phoenix WinNonlin, NONMEM, or other PK/PD-related software
- Knowledge of Neurology, Anesthesia and/or Psychiatry drug development or relevant clinical experience is desired.
- 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 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.