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Senior Director, Site Start Up & Study Optimization

Boston, Massachusetts, United States

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 Director, Site Start Up & Study Optimization is a global leadership role responsible for driving end-to-end study execution excellence across the company's clinical trial portfolio in immunology and inflammation. This individual leads and integrates critical functions including site feasibility, site start-up and activation, ongoing site engagement, Clinical Execution Lead (CEL) line management, and continuous process improvement. The Senior Director owns the full site start-up lifecycle from site selection through first patient enrollment, ensuring that regulatory, contractual, and operational milestones are met on time and in alignment with program-level objectives. This role is accountable for optimizing study timelines, enhancing site performance, and minimizing activation timelines without compromising quality or patient safety. The Senior Director partners cross-functionally with Clinical Operations leadership, Regulatory Affairs, Legal, Finance, and external partners to deliver consistent, compliant, and efficient site activation across all clinical programs.


Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday 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 global study optimization strategy to accelerate timelines and improve execution quality across all clinical programs
  • Establish standardized, scalable processes across feasibility, start-up, and site engagement, driving cross-functional alignment with Clinical Operations, Regulatory, Data Management, and external partners
  • Oversee global feasibility strategy, including country and site selection, leveraging historical performance, real-world data, and analytics to optimize enrollment forecasting and country allocation
  • Lead global site start-up and activation activities to ensure rapid study initiation, identifying and eliminating bottlenecks in regulatory submissions, contract execution, and site readiness
  • Establish and track KPIs for start-up timelines and site performance across the clinical portfolio
  • Drive ongoing site engagement strategies to maximize enrollment, retention, and data quality through consistent frameworks for site communication, support, and issue resolution
  • Partner with CROs and internal teams to ensure proactive, aligned site management across outsourced and in-house activities
  • Provide leadership, oversight, and development for the CEL organization, ensuring clear accountability for study delivery, timelines, and quality across programs
  • Build and scale a high-performing CEL team with strong execution and leadership capabilities
  • Lead global process improvement initiatives, identifying inefficiencies and implementing innovative solutions including digital tools, analytics, and risk-based approaches
  • Standardize best practices across regions and programs, championing a culture of operational excellence and continuous improvement
  • Drive CRO accountability through governance structures, KPIs, and performance management frameworks, ensuring consistency across all outsourced activities
  • Perform other duties and responsibilities as assigned


Qualifications:

  • Education: Bachelor’s degree required; advanced degree (MS, PhD, MBA) preferred
  • 12+ years of experience in clinical operations within biotech/pharma with Lupus indications a plus
  • Significant global study management experience, including Phase 2 and Phase 3 trials
  • Demonstrated leadership of complex, cross-functional teams
  • Strong experience with CRO oversight and global outsourcing models; with demonstrated experience managing Site Start Up teams in a sponsor or hybrid CRO environment across multiple concurrent clinical programs.
  • Deep expertise in the site start-up lifecycle, including feasibility, site contracts, budget negotiations, IRB submissions, and regulatory site dossier preparation.
  • Thorough knowledge of ICH GCP guidelines, FDA/EMA regulatory requirements, and country-specific regulatory submission requirements for clinical site activation..
  • Experience working in early-phase or emerging biotech environments with evolving processes and limited infrastructure is highly desirable.
  • Excellent organizational, problem-solving, and stakeholder management skills with the ability to drive accountability across matrixed teams and external partners
  • Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
  • Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
  • Adept at facilitating productive dialogue in high-stakes meetings, negotiations, and multi-party collaborations; balances clarity, diplomacy, and scientific precision.

Salary Range:

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

Salary Range

$270,000 - $304,500 USD

Benefits:

We offer a comprehensive benefits package including:

  • Medical, Dental & Vision insurance (employee premiums 100% covered by company)
  • 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge
  • Flexible work arrangements / hybrid schedule
  • Health Savings Account (HSA)

*Benefits are subject to eligibility requirements and plan terms. Additional details 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 careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

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