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Principal Scientist, Clinical Sciences
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Overview
Job Description
Job overview:
The Principal Scientist, Clinical Sciences is accountable for the scientific leadership and operational excellence of studies across assigned assets, ensuring robust clinical rationale, endpoint strategy, and patient-centred design aligned with regulatory and launch objectives.
The role partners closely with Clinical Operations, Statistics & Data Management, Clinical Safety, Regulatory Sciences, and HEOR to deliver high-quality studies, enabling timely, compliant, and insight-driven decision making.
Location: Hybrid in our New York City office or remote on the East Coast in the United States.
Reports to: Vice President, Clinical Development.
Duration: 9-month contract.
Roles and responsibilities
(Include but are not limited to):
- Maintain scientific oversight during study execution, supporting medical monitoring, protocol deviations/clarifications, Clinical Study Report quality, and interpretation of clinical signals across programs
- Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety, data integrity, and accuracy throughout the trial process
- Lead SOPs, templates, and scalable processes that implement quality and velocity across the development portfolio
- Contribute to cross-functional readiness for key milestones (database lock, regulatory interactions), establishing operating rhythms and documentation standards consistent with Compass values and governance
- Lead authorship and scientific integrity of clinical protocols, synopses, amendments, and key trial documents, integrating disease biology, patient journey insights, and regulatory feedback for psychiatric indications
- Define study objectives, endpoints, inclusion/exclusion criteria, and statistical considerations in partnership with Statistics, aligning with target product profile and pivotal-readiness standards
- Drive cross-functional protocol development forums, ensuring timely input from all relevant functions, and resolving scientific and operational trade-offs with clear decision logs
- Ensure evidence plans anticipate payer and access needs by partnering with HEOR/RWE to harmonize endpoints, PROs, and real-world relevance from protocol inception
- Champion patient-centric design, incorporating feasibility data, KOL feedback, and ethical considerations into procedures, visit schedules, and burden-reduction strategies
Candidate Profile:
- PhD in neuroscience, pharmacology, or related life sciences field, or MD/PharmD with equivalent clinical development experience
- Required industry experience in biopharma/biotech clinical development with demonstrated leadership in protocol authorship and late-stage study design; CNS experience strongly preferred
- Proven capability to translate biology and patient insights into clear study objectives, endpoints, and operationally feasible designs
- Strong cross-functional collaboration; skilled at guiding teams through complex scientific choices and change
- Excellent scientific writing, data interpretation, and communication skills, with a track record of high-quality clinical documents and timely milestone delivery
- Mission-aligned, inclusive contributor who reflects Compass values and a wellbeing-first, stigma free culture
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