Biopharmaceutical Development Operations Director
7 days ago
About Day One Biopharmaceuticals
Day One Biopharmaceuticals is an emerging, mission-driven company dedicated to identifying, clinically evaluating, and successfully commercializing novel treatments for pediatric oncology patients. Our goal is to expand these benefits to patients of all ages.
We are a team of experts passionate about making a difference in the lives of people affected by cancer. Our innovative approach focuses on delivering high-quality medicines that meet the needs of our patients.
Job Summary
The Director, Development Business Operations plays a critical role in ensuring 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 is a fully remote opportunity.
Responsibilities
- Oversight of the business operations process and innovation implementation efforts for Development Operations.
- Management of Dev Ops documents and standards process.
- Leadership in key process document creation, update or obsoletion of Dev ops documents.
- Connection of key CAPA outputs cross-functionally and dissemination of their impact into Development Operations processes.
- Tracking, management, and closure of requested updates to dev ops process.
- Organization of leadership meetings and tracking and closure of action items.
- Demonstration of accountability and leadership in managing external partners and vendor performance.
- Fostering of cross functional relationships to promote effective communication of processes, changes, and gaps.
Key Qualifications
- Bachelor's degree preferably in a scientific field.
- At least 10 years of project management experience, including 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 with excellent communication and team management skills.
- Experience in managing multiple complex projects in a fast-paced environment.
- Participation/experience with regulatory audits and inspections is preferred.
Compensation
The estimated hourly rate for this position is between $100/hour and $130/hour, considering factors such as location and qualifications.
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