ASSOCIATE DIRECTOR, DEVELOPMENT OPERATIONS

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 Associate Director, Development Operations leads both indirect and direct reports, external partners, consultants, and vendors to ensure the timely and cost-effective implementation of clinical trials. This role provides guidance and direction to assigned staff, as well as ensuring growth and development of direct reports. This role assesses CROs and vendors for implementation of clinical development plan and supports the review and approval of contracts and/or work order changes. The Associate Director is instrumental in managing vendor partnerships.

This role establishes and maintains effective communication and collaboration with functional colleagues and thought leaders to achieve company, functional, program, and study goals. The position supports the team with ensuring the completeness and accuracy of the study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. The Associate Director, Development Operations collaboratively leads program initiatives to support Development Operations expansion as an organization.

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensures multiple Ph I-III clinical trials are executed within designated program scope, budgets and timelines
• Collaborates and influences cross functionally to ensure timely delivery of assigned studies
• Serves as the primary point of contact for clinical trial management within the Sponsor organization
• Drives site selection, start-up, enrollment strategies and patient retention efforts
• Monitors and reports on trial progress, metrics, and risk mitigation strategies to senior leadership
• Participates in audits and inspections and ensures audit readiness of assigned trials
• Reviews and contributes to Clinical Protocols, study plans, manuals, and templates
• Provides problem-solving expertise to clinical trials, and monitors trial key performance indicators to ensure timely execution of milestones
• Ensures all trials are conducted according to budget, including regular forecasting in partnership with Finance. Oversees the administration of invoice reconciliation, scoping, and change orders,
• Provides oversight and guidance to team on managing the creation, maintenance and close out of TMF activities and contributes to TMF inspection readiness
• May attend qualification, initiation, interim monitoring, and close-out visits.
• Ensures all trials are conducted in accordance with Standard Operating Procedures, established guidelines and work instructions, and applicable regulations (FDA, ICH-GCP, EMA) guidelines and Good Clinical Practices
• Leads departmental Clinical process or operational initiatives. Contributes to Development Operations SOPs and/or governance documents
• Recruits, hires, manages and develops Development Operations resources to ensure optimization across trials or projects

QUALIFICATIONS

• BS/BA degree in life sciences, healthcare, or related field required; advanced degree (MS, MPH, PharmD, PhD) preferred
• Typically requires a minimum of eight (8) years of clinical research experience, with at least 3 years in trial management or equivalent leadership role
• Oncology and/or rare disease experience is required
• Prior experience managing Phase I – III clinical trials in a Sponsor and/or CRO environment
• Extensive clinical operations knowledge and cross-functional understanding of global clinical trial methodology
• Experience developing trial plans (e.g., site monitoring, communication, issue escalation)
• Knowledgeable in clinical database platforms, interactive response technology (IRT) applications and processes, and clinical supply logistics
• Deep understanding of Good Clinical Practice, regulatory requirements and their application to the development and conduct of global clinical studies.
• Experience applying strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques
• Experience dealing with complexity and ambiguity; ability to collect, analyze, and communicate information
• Ability to communicate vertically and horizontally through multiple channels, motivate diverse teams, and foster cross-functional collaboration
• Prior experience managing full-time and/or contract employees
• Works on assigned problems of complex scope with analysis of situation or data required
• Exercises judgment within defined procedures and practices to determine appropriate action
• Builds productive internal and external working relationships

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 $180,000 - $195,000. 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.