Beeline Medicines

Senior Clinical Trial Manager

United States · Senior

Sponsorship not specified$178k-$195kDetected 2 days ago

GCPProcess ImprovementClinical TrialsLeadershipCommunicationCollaborationProblem SolvingMentoringGxP

About the role

This role is responsible for ensuring studies are delivered on time, within scope, and in compliance with regulatory standards, Good Clinical Practice (GCP), and company Standard Operating Procedures (SOPs).
This individual will also play a critical role in driving strategic decision-making and supporting inspection readiness and regulatory submissions.
Remote - This position is designated as remote

Lead the operational strategy, planning, and execution of global Phase 1-4 clinical trials in immunology indications (e.g., autoimmune and inflammatory diseases).
Serve as the primary operational point of contact for internal stakeholders and external partners.
Drive site feasibility, site selection, activation, patient recruitment strategies, and ongoing site management to ensure achievement of enrollment goals.
Develop and maintain study timelines, risk mitigation strategies, and operational tracking tools.
Collaborate with cross-functional teams on protocol development, CRF design, ICF review, and development of operational study plans.
Oversee data collection activities, database lock readiness, and support data review processes.
Perform other duties and responsibilities as assigned

Minimum 5 years of experience in clinical operations in the biopharmaceutical industry, with at least 3 years in a Senior CTM or equivalent leadership role.
Proven track record of managing global, multi-center clinical trials in immunology or autoimmune disease indications.
Experience with biologics, monoclonal antibodies, or advanced therapies.
Strong knowledge of GCP/ICH guidelines, clinical trial regulations, and operational best practices.
Experience in rare autoimmune indications or immune-mediated inflammatory diseases.
Experience in early- to late-stage development programs, including pivotal trials.
Proficiency with electronic systems such as CTMS, EDC, eTMF, and risk-based monitoring tools.
Ability to thrive in a fast-paced, dynamic environment and work independently with minimal supervision

$178,000 - $194,500 USD
The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired.
Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law.
A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices.
Competitive health and wellness coverage (structure and premiums vary by country)
Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
Specific benefit details applicable to your country or region will be provided during the offer process.
Benefits may include, but are not limited to:
Flexible work arrangements / hybrid schedule
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.
With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact.
Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully.
The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation.
We are committed to providing equal access to all candidates.
Beeline Medicines is an Equal Opportunity Employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.

This listing is sourced directly from Beeline Medicines's careers page and normalized into a canonical job model.