Sage Therapeutics Associate Director, Clinical Pharmacology in EMAIL: Workday@Sagerx.com, Massachusetts
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, 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 as well as perform PK and PK/PD analyses to support the development of the drug. 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 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 PK/PD analysis, including population PK, PK/PD modeling and simulation, meta-analysis, etc.
Responsible for ensuring/performing appropriate PK/PD analysis, including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling as required by the program to aid in dose selection, trial design, and/or program decision-making.
Develop clinical pharmacology data analysis plans.
Represent 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.
Ensure 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.
Prepare responses to inquiries from regulatory agencies with supervision.
Monitor adherence to protocols and determine study completion.
Develop and nurture effective, positive, and productive relationships with investigators and KOLs for the design of clinical pharmacology trials and programs, as well as with CROs and cross-functional teams internally at Sage (Medical Science, Data Science, Clinical Operations, Regulatory, and DMPK).
Collaborate 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. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a 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.
MD, PharmD, or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering, or a related field with 3+ 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.
A diplomatic professional that ‘clicks’ easily with the company and leadership, with the foresight and savviness 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 performing highly independent work as well as being a team player and role model. A key ability for being successful is interfacing with Clinical Operations.
Proven ability to manage multiple projects and 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 CROs.
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.
Number of Openings:
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All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
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.
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