Senior Clinical Trial Manager (Immunology)

Beeline Medicines; Boston; Remote; PHP 9,393,000 - 12,179,000; Full time

Benefits offered by this job

Remote-friendly

Hybrid schedule

Discretionary bonus

Long-term incentive

Job summary

Beeline Medicines is seeking a Senior Clinical Trial Manager to lead the operational planning, execution, and oversight of complex, global immunology and autoimmune disease trials. This role partners with internal teams and CROs to ensure timely delivery, regulatory compliance, and inspection readiness.

The ideal candidate has 5+ years in clinical operations with 3+ years in senior CTM roles, experience with biologics, and a strong grasp of GCP/ICH guidelines.

Qualifications

• Bachelor’s degree in life sciences or related field (advanced degree preferred).
• Minimum 5 years in clinical operations in biopharma, with 3+ years in Senior CTM or leadership role.
• Proven track record managing global, multi-center trials in immunology/autoimmune indications.
• Experience with biologics/monoclonal antibodies/advanced therapies.
• Strong knowledge of GCP/ICH and regulatory requirements.

Responsibilities

• Lead operational strategy, planning, and execution of global Phase 1–4 trials in immunology indications.
• Serve as primary operational contact for internal and external stakeholders.
• Oversee CRO/vendor selection, budgeting, contracting, and performance oversight.
• Drive site feasibility, activation, and patient recruitment strategies.
• Develop study timelines, risk mitigation, and operational tracking tools.
• Collaborate on protocol design, CRF, ICF review, and operational study plans.
• Ensure compliance with GCP/ICH and local regulations.
• Identify and resolve operational issues; escalate risks as needed.
• Oversee data collection, database lock readiness, and data reviews.
• Contribute to regulatory filings, inspection readiness, and audits.
• Provide leadership and mentorship to Clinical Operations team.
• Contribute to process improvements in Clinical Operations.

Skills

Program management

GCP/ICH knowledge

Cross-functional leadership

Regulatory submissions

Risk-based monitoring

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

CTMS

EDC

eTMF

risk-based monitoring tools

Job description

About Beeline Medicines

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.

Job Summary

The Senior Clinical Trial Manager (Sr. CTM) will lead the operational planning, execution, and oversight of complex, global clinical studies in the field of immunology and autoimmune diseases. 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). The Sr. CTM will partner closely with internal cross-functional teams (Clinical Development, Regulatory, Biometrics, Safety, and Quality) and external partners (CROs, vendors, and sites) to ensure operational excellence. This individual will also play a critical role in driving strategic decision-making and supporting inspection readiness and regulatory submissions.

Work Arrangement & Location

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Essential Duties and Responsibilities

• 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.
• Oversee the selection and management of CROs and other vendors, including scope of work, budget development, contracting, and performance oversight.
• 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.
• Ensure studies are conducted in compliance with GCP/ICH guidelines, local regulatory requirements, and internal SOPs.
• Proactively identify and resolve operational issues, escalating risks and implementing mitigation strategies as needed.
• Oversee data collection activities, database lock readiness, and support data review processes.
• Contribute to regulatory filings, inspection readiness, and audit preparation.
• Provide leadership and mentorship to Clinical Operations team members.
• Contribute to process improvement initiatives within Clinical Operations to enhance efficiency and quality.
• Perform other duties and responsibilities as assigned

Qualifications

• Education: Bachelor’s degree in life sciences or related field (advanced degree preferred)
• 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.
• Familiarity with adaptive trial designs or complex biomarker-driven studies.
• 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
• Excellent communication, leadership, and problem-solving skills.
• This position requires availability during Eastern Time (ET) business hours
• This role may require domestic and international travel, including overnight stays, up to 20% or more based on business needs

Salary Range

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.

$150,000 — $194,500 USD

Benefits

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• 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
• Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Equal Employment Opportunity

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation

If you require a reasonable accommodation to participate in the application or interview process, please contact [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.