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Praxis Precision Medicines, Inc. · 1 day ago

Clinical Operations Lead

United States

Full-time

Remote

Senior Level, Lead/Staff

$170K/yr - $215K/yr

8+ years exp

Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. They are seeking a Clinical Operations Lead to drive clinical studies from protocol to database lock, ensuring timely and budget-compliant execution while collaborating cross-functionally to overcome challenges.

Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine

Comp. & Benefits

Responsibilities

Lead the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans and strategy and according to established timelines and budget

Serve as a Clinical Operations representative at the program level and liaise cross-functionally to support efficient and timely execution of studies within a clinical program

Monitor progress of clinical study activities and report on the progress of the clinical trials within an assigned program, including budget and timelines

Lead the evaluation, selection, and oversight of CROs and other vendors to ensure successful clinical study implementation and execution on assigned clinical program. This includes guidance on the framework for contract negotiations and vendor selection, and review and approval of vendor contracts and scope of works

Provides strategic and tactical guidance in risk management and anticipate/recognize risks and issues on assigned programs and associated studies; manage resolution and/or escalation of study related issues with management

Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, clinical study reports and DSURs on assigned program

Liaise with clinical site staff and investigators as appropriate to ensure optimal Sponsor-site relationships

May perform the Clinical Trial Manager (CTM) function on one or more trials as needed

Direct initiatives to identify and implement best practices and continuous improvement plans in Clinical Operations

Qualification

Clinical trial managementStudy designExecutionRegulatory knowledgeCRO managementCross-functional collaborationMentoring experienceProblem solvingCommunication skillsOrganizational skills

Required

Bachelor's degree required; in a scientific field helpful, advanced scientific degree a plus

8+ years Industry experience directly managing clinical trials required. Must have worked within sponsor organization, although can be in combination with academic and CRO experience

In-depth knowledge of clinical study operations, ICH-GCP Guidelines and other applicable regulatory requirements

Demonstrated experience in study management/monitoring, as well as working, negotiating and managing performance of CROs and other external partners supporting study execution

Experience mentoring and directing members of clinical operations teams

Experience working with cross functional team members (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply Chain, Finance)

Intellectual curiosity: ability to think critically in a fast-paced environment, with a keen sense of urgency and demonstrated creative problem solving

Highly organized, detail-oriented, and self-motivated and able to work autonomously, with a passion to deliver quality results

Strong verbal and written communication skills with an ability to build relationships internally and externally

Benefits

99% of the premium paid for medical, dental and vision plans.

Company-paid life insurance

AD&D

Disability benefits

Voluntary plans to personalize your coverage.

We match dollar-for-dollar up to 6% on eligible 401(k) contributions

Long-term stock incentives

ESPP.

Discretionary quarterly bonus

An extremely flexible wellness benefit

Generous PTO

Paid holidays

Company-wide shutdowns.

Company

Praxis Precision Medicines, Inc.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.

Founded in 2015

Cambridge, Massachusetts, USA

51-200 employees