Senior Director, Clinical Science

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, 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, Beeline Medicines brings scientific rigor and operational excellence to realize a world where people with immune-mediated diseases can live life fully.

About the role

The Senior Director, Clinical Science provides senior scientific and strategic leadership for the design, execution, and interpretation of clinical trials across one or more therapeutic programs. This role acts as a key scientific expert and thought partner to program and functional leadership, shaping clinical development strategy from early-phase proof-of-concept through late-stage registration and lifecycle management. The position requires close collaboration with Biostatistics, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and external investigators and key opinion leaders to ensure trial designs are scientifically sound, operationally feasible, and aligned with evolving regulatory expectations.

This is a hybrid role requiring a minimum of two (2) days on-site per week (currently Tuesday and Wednesday). Additional on-site days may be required based on business needs.

Responsibilities

• Serve as the senior clinical/scientific lead on cross-functional study teams, providing scientific direction for protocol design, endpoint selection, and data interpretation.
• Author and critically review clinical study protocols, statistical analysis plans, clinical study reports, and regulatory submission documents (e.g., IND/NDA/BLA sections, briefing documents).
• Partner with Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs to ensure scientifically sound and operationally feasible trial designs.
• Support the design and execution of multiple clinical studies across the development plan.
• Oversee Study Medical Manager responsibilities from setup through CSR completion, including CRF design, study start-up activities, enrollment monitoring, and patient profile reviews.
• Lead the clinical interpretation of emerging safety and efficacy data, including ongoing monitoring of trial data and contribution to Data Safety Monitoring Board materials.
• Represent clinical science in interactions with regulatory authorities, key opinion leaders, and external scientific advisory boards.
• Contribute to the design and execution of clinical development strategy, including lifecycle management and indication expansion planning.
• Lead the development and execution of Clinical Science strategy, priorities, and long-term organizational objectives.
• Co-lead establishment of a company-wide clinical trial data management and analytics platform.
• Develop future leaders by mentoring Clinical Scientists and associate clinical scientists across program teams, strengthening scientific, strategic, and leadership capabilities.
• Perform other duties and responsibilities as assigned.

Requirements

• PhD, PharmD, in a relevant scientific or clinical discipline or equivalent experience.
• 12+ years of clinical research/clinical development experience in the biopharmaceutical or pharmaceutical industry, including significant experience in a clinical science leadership role.
• Demonstrated experience authoring clinical protocols, CSRs, and regulatory submission documents.
• Experience interacting directly with global regulatory agencies (e.g., FDA, EMA) preferred.
• Experience in autoimmune, immunology, or inflammation indications strongly preferred.
• Deep knowledge of clinical trial design, GCP, and global regulatory requirements.
• Strong scientific and clinical data interpretation skills, including familiarity with statistical concepts.
• Proficiency with clinical trial management and data visualization tools.
• Proven ability to lead and influence cross-functional teams without direct authority.
• Experience mentoring and developing junior scientific staff.
• Sound judgment in escalating and resolving complex scientific and operational issues.
• Excellent written communication skills, including regulatory and scientific document authoring.
• Strong verbal communication and presentation skills for internal leadership and external regulatory/scientific audiences.
• Ability to translate complex scientific data into clear, actionable insights for varied audiences.

Pay

The expected salary range for this position is $266,000 - $344,000 USD. Actual pay will be determined based on experience, qualifications, location, and other job-related factors. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

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:

• 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.