DIRECTOR, DEVELOPMENT BUSINESS OPERATIONS (Contractor)
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.
POSITION SUMMARY:
The Director, Development Business Operations is accountable for the strategic implementation of business operations services to support delivery of Phase I-IV essential functions and safety capabilities for the function. This position reports to the Sr. Director Development Operations.
This position has the potential to be fully remote.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Leadership:
· Oversight of the business operations process and innovation implementation efforts for Development Operations.
· Manages Dev Ops documents and standards process.
· Leads key process document creation, update or obsoletion of Dev ops documents.
· Connects key CAPA outputs cross-functionally and ensures their impact is disseminated and incorporated into Development Operations processes.
· Ensures that requested updates to dev ops process are tracked, managed, and closed.
· Organize leadership meetings and ensure the tracking and closure of action items.
· Demonstrate accountability and leadership in managing external partners and vendor performance.
· Build and foster cross functional relationships to promote and support effective communication of processes, changes, and gaps. Critical thinking and analytical skills and ability to make high level decisions in cross-functional and global environments.
· Ability to review, analyze, interpret, and present complex data to a high standard.
People:
· Leads onboarding of all new employees or contractors, including notification to functions of onboard date, training plan assignment, equipment, and system access request.
· Leads offboarding of all employees and contractors to ensure continuity of information.
· Ensure all CVs are current and stored for access in audits and inspections.
· Monitors adherence to individual training plans and ensures compliance or escalation to Sr. leadership when an FTE or contractor is not in compliance.
· May have direct reports.
Process:
· Key contributor to proactively identifying process gaps across Development Operations and proposes solutions to address and implement the gaps. Develop, refine, and monitor policies and procedures to meet quality and compliance standards.
· Owns the training process for Development Operations.
· Leadership support for the Dev Ops SME Council
· Develops roles for training across Development Operations
· Attends the Document and Standards meeting as the Development Operations representative.
· Shepherds controlled documents through QA process aligning on approved and effective dates.
· Implements and maintains a controlled documents change tracker for requests to Development Operations Policy, SOPs, WIs and Guides
· Initiates controlled document templates for new Policy, SOP, WIs and Guides Collaborates with the Sr. Director of Development Operations on changes to strategy, cross-functional process changes, regulatory changes to ensure controlled documents have an impact assessment and are sent to the SME Council for update and closure.
· Develops the Box structure for document management across Development Operations.
· Owns the psiXchange process for all clinical trials and EAP, IST, and CUP trials.
· May provide support for meeting management and minutes for key department meetings.
· Owns Safety training (GUI-001) and trains vendors where required.
· Review Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation Plans
· Excellent organizational skills and ability to prioritize individual and departmental workloads.
· Multi-tasking with the ability to successfully manage multiple critical issues simultaneously.
· Take the initiative to patriciate in projects outside the direct remit of the job to enhance visibility of the department and ensure cross functional awareness and connectivity.
Vendors:
· Initiates shared spaces with the vendor for document management.
· Oversees access to all SOP’s, WIs, Guide’s utilized by the vendor for completion of DOB work.
· Manages links provided by vendors to ensure awareness and access as required by the dev ops team.
Quality:
· Partners with Director, Development Operations Quality, Compliance and Standards to ensure close-out of CAPAs and dissemination to Development Operations team and cross-functional teams when applicable.
· Partners with Director Development Operations Quality, Compliance and Standards and Quality Assurance to develop the strategic plan to support inspection readiness activities for study specific Inspections, audit requests, and TMF audits.
· Influence others and work collaboratively across functions to align on best practices and processes.
· Review Study level documents including Safety Management Plans, Study Safety Summaries and SAE Reconciliation Plans
· Consult with and advise study teams including Clinical Science, Data Management, Regulatory Affairs, and other functional areas locally/globally on matters relating to Pharmacovigilance Operations to ensure overall compliance and appropriate standards and methodologies within the company.
QUALIFICATIONS
· Bachelor's degree preferably in a scientific field.
· At least 10 years of project management experience, which includes cross functional and team leadership.
· Considered SME for SOPs, Inspection Readiness, process innovation initiatives, and advancement of Development Operations as an organization.
· Demonstrated strong leadership competencies in a matrix environment.
· Proactive problem solver, excellent communication and team management skills.
· Experience in managing multiple and complex projects in a fast-paced environment.
· Participation/experience with regulatory audits and inspections is preferred.
· Excellent communication skills and management skills with attention to detail.
· Strong understanding of ICH, GCP and relevant regulatory requirements
· Proficiency with Box, Smartsheet’s, Microsoft Outlook, Excel, Word, PowerPoint.
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
The hourly range for this position $100/hour - $130/hour. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
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.
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.
