Director, Clinical Data Management

About Beeline Medicines:

Beeline Medicines is a clinicalstage 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 Director Clinical Data Management (CDM) is a senior leadership role responsible for the strategic direction operational execution and continuous improvement of all clinical data management activities across the companys pipeline. This is a hands-on visible leadership position that will shape the data management strategy from the ground up partnering closely with cross-functional teams within the R&D organization and external partners to advance the companys clinical development programs.

Reporting to the Vice President of Biometrics this individual will establish best-in-class data governance standards and ensure the integrity quality and regulatory compliance of clinical trial data from study startup through database lock and submission. The ideal candidate will bring strong vendor and CRO oversight experience a commitment to data quality and the ability to build scalable processes that support a growing pipeline.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule requiring a minimum of two (2) days on-site per week currently designated asTuesday and Wednesday. Additional on-site days may be required based on business needs team priorities or leadership direction.

Essential Duties and Responsibilities:

• Develop and implement a fit-for-purpose operating model for data management aligned with company goals including policies procedures and best practices for data collection processing and review in clinical trials.
• Provide strategic and operational leadership for all CDM functions including data collection cleaning validation and database lock activities across Phase IIII clinical trials.
• Define and implement the long-term CDM strategy aligned with corporate development goals regulatory expectations and industry best practices.
• Serve as the senior CDM representative on cross-functional program teams contributing to study design protocol development and integrated development plans.
• Establish and monitor departmental KPIs resource plans and budgets; provide regular status updates to senior leadership.
• Oversee the development and review of key CDM study documents including Data Management Plans (DMPs) Case Report Form (CRF) design specifications edit check specifications data validation plans and database lock checklists.
• Direct the implementation validation and management of Electronic Data Capture (EDC) systems (e.g. Medidata Rave Veeva Vault EDC Oracle Clinical); ensure systems are fit-for-purpose and validated per applicable regulations.
• Ensure timely and accurate data cleaning discrepancy management medical coding (MedDRA WHO Drug) and reconciliation of external data sources (e.g. central labs ePRO safety data).
• Lead database lock activities ensuring all data quality checks outstanding queries and audit trails are resolved and documented prior to lock.
• Manage relationships with external vendors and CROs including selection contract negotiation performance monitoring and issue resolution to ensure high-quality timely and cost-effective data deliverables.
• Oversee the management and quality oversight of CDM activities conducted by CROs and other third-party vendors; review vendor deliverables and hold partners accountable to contractual timelines and quality standards.
• Ensure all CDM activities comply with ICH E6(R2) GCP guidelines 21 CFR Parts 11 and 312 GDPR and other applicable global regulatory requirements.
• Lead the development and maintenance of CDM Standard Operating Procedures (SOPs) work instructions and department-level quality standards; drive adoption across internal staff and CRO partners.
• Partner with clinical regulatory and quality teams to integrate data management into study protocols risk-based monitoring plans and submission packages; contribute to IND/NDA filings and audit preparations.
• Support regulatory inspections and internal audits; serve as the primary CDM contact for health authority inquiries related to data management practices.
• Ensure data security privacy (e.g. GDPR HIPAA) and compliance with global regulations; support regular audits and implement corrective actions as needed.
• Proactively identify data quality risks and implement mitigation strategies; conduct root cause analyses for data issues and drive corrective and preventive actions (CAPAs).
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Bachelors degree required in a life sciences health informatics computer science or related field;Advanced degree (e.g. M.S. M.P.H. or Ph.D.) in a relevant discipline is strongly preferred.
• Minimum of 10 years of progressive experience in clinical data management within the pharmaceutical biotechnology or CRO industry.
• 3 years experience direct vendor management and oversight preferred
• Experience in immunology or autoimmune therapeutic areas preferred
• Proven experience managing CDM activities across all phases of clinical development (Phase IIII) including late-stage and/or registration-enabling trials.
• Direct experience with global regulatory submissions (IND NDA BLA or MAA) and health authority inspections (FDA EMA) is strongly preferred.
• Experience in a lean or early-stage biotech environment including building CDM functions or infrastructure from the ground up is a significant advantage.
• Prior experience managing CRO relationships and overseeing outsourced CDM activities at a strategic level.
• Exceptional leadership presence with the ability to influence cross-functional stakeholders including senior executives without direct authority.
• Strategic thinker with the ability to translate business and scientific objectives into actionable CDM plans and operational processes.
• Strong project management skills; capable of managing multiple concurrent studies and priorities in a fast-paced resource-constrained environment.
• Excellent written and verbal communication skills including the ability to present complex data management concepts to non-technical audiences.
• Demonstrated ability to navigate ambiguity and drive decisions in an evolving early-stage company environment.
• Collaborative team-oriented work style with a track record of building productive relationships across functions and with external partners.

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 to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S. Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines