SENIOR CLINICAL PROJECT MANAGER (Contract)
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical 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:
We are searching for a creative, resourceful, integrative thinker for a key role that will be responsible for development and management of project priorities, dependencies, scope, risk and project resources.
The Senior Clinical Project Manager is responsible for overseeing and successfully delivering complex projects for Development Operations. You will collaborate with stakeholders and cross-functional teams to ensure project scope is met on time with the highest level of quality. The Sr. CPM collaborates with internal teams and external partners, develops objective business perspectives, assesses risks, and creates measurable implementation plans. The ideal candidate will have a proven track record of managing complex projects, exceptional leadership abilities, and excellent communication skills.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Manage and support multiple projects' priorities, dependencies, scope, risks, and project resources.
· Build integrated timelines across trials and functions to exhibit deliverables, competing priorities, major milestones.
· Collaborate with DevOps for CRO delivery discussion regarding timelime, cost and delivery per the contract.
· Lead program and project reviews, fulfilling reporting requirements.
· Collaborate with cross-functional teams to assess risks, define scope and budget, and develop project schedules and plans.
· Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track
· Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline.
· Build and maintain project management documents such as project plan, RAID (risks, actions, issues, and decisions) log, charter, and communications plan.
· Ownership and support of SharePoint, Slack channels, Smartsheet, and other communication & tracking systems.
· Communicate and report project updates to stakeholders and risk escalations to leadership team.
· Ensure projects adhere to portfolio flow, and documentation and gate criteria meet project management standards.
· Foster a collaborative and high-performing project team environment, providing guidance, support, and mentorship to team members.
· Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations
· Promote effective communication and teamwork among project members.
QUALIFICATIONS
· BS/BA in physical science, Communication, Nursing or technical field (such as chemistry, engineering, biology, mathematics)
· 10+ years project management experience with focus in pharmaceutical or biotechnology industry.
· Extensive experience in leading complex, cross-functional projects or programs with expertise in R&D and understanding of manufacturing, materials management, procurement, supply chain, quality, and regulatory affairs.
· Ability to apply a wide range of disciplines, including business requirements analysis, project planning, scheduling, cost control, and economic analysis, to manage projects and programs effectively.
· Demonstrated time management skills, particularly in calendar management and goal setting.
· Proficient in MS Office tools (PowerPoint, Word, Excel, Project, Visio) and other project management software such as SmartSheets.
· Well-versed in governmental regulations, including FDA, EMA, MHRA regulations
Preferences
· Strong knowledge of regulatory requirements
· Certification as a Project Management Professional by the Project Management Institute (PMI)
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
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.