Director, Clinical Development Sciences

Beeline Medicines

1d • $225,000 - $250,000 • Remote

About The Position

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 Director, Clinical Data Science is a senior individual-contributor subject matter expert responsible for the quality, integrity, and scientific interpretation of clinical trial data within a therapeutic area of deep specialization. This role partners with clinical operations, biometrics, medical affairs and cross functional R&D colleagues to design and apply bespoke data quality analytics, identify emerging efficacy and safety trends, support real time study execution through the monitoring of collected data, and ensure collected clinical data supports sound scientific and regulatory decision-making. The Director serves as the organization's internal expert on disease-specific endpoints and outcome measures, is recognized internally and externally as a scientific leader in the therapeutic area and works closely with Key Opinion Leaders (KOLs), investigators, and study teams to safeguard data quality from study start-up through database lock and reporting. The role also provides trial design, endpoint, and data strategy consultation to teams advancing novel therapeutic modalities within the therapeutic area.

Requirements

• Advanced Degree (MS, PharmD, Ph.D in Statistics, a life science, or a related field or equivalent years of experience
• 10+ years of progressive clinical research and/or clinical data experience, including significant experience in clinical data science or data quality management within a CRO, pharmaceutical, or biotech setting
• Experience developing bespoke data quality analytics for disease-specific endpoints, in collaboration with KOLs and cross-functional teams.
• Experience contributing to protocol development, CRF design, and site selection.
• Advanced proficiency with clinical data review/analytics platforms (e.g., JReview, Tableau, Spotfire, or similar).
• Working knowledge of EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva, ClinicalInk, or similar).
• Advanced Excel skills, including user-defined functions; SQL and/or SAS programming proficiency a plus.
• Ability to lead cross-functional discussions and influence decision-making without direct authority.
• Demonstrated ability to mentor and train colleagues on disease area expertise and data quality methods; recognized as a go-to expert whose data quality methodologies and disease-area insights are adopted beyond assigned studies.
• Strong written and verbal communication skills; able to translate complex data findings into clear, actionable insights for clinical and Medical Affairs stakeholders.
• Experience collaborating with and presenting to Key Opinion Leaders (KOLs), investigators, and senior leadership.

Nice To Haves

• Prior authorship or co-authorship of scientific manuscripts, abstracts, or presentations preferred.
• External recognition as a scientific leader in the therapeutic area (e.g., established Key Opinion Leader relationships, invited presentations, or industry recognition) preferred.

Responsibilities

• Lead site-, country-, and global-level clinical data quality management across assigned clinical trials, ensuring data integrity from first patient in through database lock; provide data-informed input to site management decisions, including recommendations regarding site retraining or closure based on disease understanding and quality findings.
• Develop and maintain bespoke data quality analytics for disease-specific efficacy, safety, and outcome measures, partner with Key Opinion Leaders (KOLs) and study teams to validate methodologies; contribute novel measures that are adopted as data quality standards across the therapeutic area.
• Identify data trends and irregularities at baseline and throughout each study; lead root-cause analysis with functional area teams and drive remediation strategies through to resolution.
• Provide data-informed input to site management decisions, including recommendations regarding site retraining or closure based on disease understanding and quality findings.
• Lead clinical data science input to protocol development, case report form (CRF) design, and site selection; own training materials and functional/quality plan creation; contribute to clinical sections of clinical study reports (CSRs) and program documents (INDs, NDAs/BLAs, CTAs, Briefing Documents, IBs, DSURs, etc.).
• Serve as the subject matter expert and internal resource on disease area endpoints and trial design considerations; train and mentor colleagues on relevant measures and quality approaches; recognized internally and externally as a scientific leader in the therapeutic area.
• Provide trial design, endpoint strategy, and CRF consultation to teams advancing novel therapeutic modalities within the therapeutic area.
• Lead data interpretation and quality-related scientific input for manuscripts, abstracts, and presentations, in partnership with Biostatistics and Medical Writing colleagues.
• Contribute to clinical sections of clinical study reports (CSRs) and program documents (INDs, NDAs/BLAs, CTAs, Briefing Documents, IBs, DSURs etc.)
• Perform other duties and responsibilities as assigned

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director