DIRECTOR, CLINICAL SITE MONITORING OVERSIGHT

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY:

The Director, Clinical Site Monitoring Oversight is responsible for ensuring robust sponsor oversight of site monitoring activities across all phases of clinical development. This leadership role ensures operational excellence, compliance, and continuous improvement of monitoring execution, with a focus on monitoring processes, planning, and training excellence. The Director also plays a critical role in maintaining Trial Master File (TMF) inspection readiness and ensuring alignment with regulatory and GCP expectations.This role reports to Senior Director, Development Operations.

This position has the potential to be fully remote. Domestic US and International travel of up to 30-40%, and in support of trial activities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and maintain sponsor monitoring oversight strategies and plans, including oversight monitoring visits, quality review activities, and escalation pathways (including PSSV, SIV, etc.) based on audit and inspection findings to close critical gaps.
• Track activities and the vendor oversight plans and ensure compliance at the site level.
• Provide strategic oversight and performance management of CRO partners responsible for site monitoring, ensuring execution is compliant with ICH-GCP, regulatory requirements, and study plans.
• Establish, track, and analyze KPIs and quality metrics for monitoring activities; lead risk assessments and performance reviews with CROs.
• Conduct sponsor visits to oversee CRO performance, monitor critical data and processes, and support issue resolution.
• Collaborate with CQA and study leads to develop study and vendor oversight plan, identify risks and corrective actions across the department and study sites

Inspection Readiness

• Serve as a TMF functional area lead to ensure continuous TMF health, completeness, and compliance across all trials
• Collaborate with study teams, CQA and regulatory to support audit and inspection preparation, including documentation reconciliation, CAPA management, and inspection activities (this includes site inspection preparation)

TMF Site Oversight

• Support TMF inspection readiness
  • Review ISF and TMF for reconciled documents that meet quality standards.
  • Participate in TMF oversight for Day One
  • Recommend updates or changes to processes as Day One matures the TMF process

Leadership and Collaboration

• Serve as a senior representative of Development Operations in cross-functional meetings, providing insight and oversight related to site monitoring, TMF, and training strategy.
• Mentor and guide internal team members and contribute to the professional development of CRO monitors when applicable.
• Support departmental initiatives, SOP development, and inspection readiness plans.

QUALIFICATIONS

• Bachelor’s degree in life sciences or a related field required; advanced degree (MS, PharmD, PhD) preferred.
• 10+ years of clinical research experience, including 5+ years in sponsor-side oversight of CRO monitoring activities.
• Proven expertise in clinical site management, CRO/vendor oversight, and monitoring visit execution.
• Strong knowledge of ICH-GCP, FDA and global regulatory requirements.
• Demonstrated experience in leading site monitoring processes and training programs.
• Deep understanding of TMF requirements and inspection readiness.
• Excellent leadership, communication, organizational, and problem-solving skills.
• Proficiency in eTMF platforms (e.g., Veeva Vault), CTMS, and clinical documentation systems

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

COMPENSATION AND BENEFITS

The salary range for this position is $215,000 - $235,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.