Senior CMC Project Manager
Senior CMC Project Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The candidate in this position is responsible for supporting Pharmaceutical Development (PharmDev) program management for one or more of ORICs novel therapeutic development products. Responsibilities will include supporting the internal PharmDev teams to progressively advance the nonclinical and clinical development of small molecule therapeutics to meet Development Team goals and coordination oversight/management and operational support of manufacturing and analytical activities conducted at CXOs. This individual will also be responsible for tracking Pharmaceutical Development timelines budgets invoices CXO reports and documentation and may assist with regulatory filings. The successful candidate will report to the Sr. Director of Program and Project Management and will be responsible for the following:
Responsibilities
- Work with the team to ensure uninterrupted clinical supply
- Provide technical project management and operational support for internal Pharmaceutical Development project teams.
- Define and monitor progress on deliverables and maintain timelines and budgets in alignment with Development Team goals leveraging program management best practices.
- Ensure successful such that development projects achieve goals objectives and deliverables and progress towards regulatory and clinical milestones
- Collaborate closely and effectively with PharmSci functional reps Regulatory affairs Quality assurance Finance Commercial and Supply Chain teams and Development Team to execute supply strategies seamlessly
- Actively manage the relationships performance and productivity of CXO partners to ensure maximum value from the service providers
- Document and file all reports technical documents and communications conducted with CXOs
- In partnership with PharmSci leadership and technical SMEs implement service agreements with CXOs forecast and track project budgets and effectively partner with the Finance group to provide timely reconciliation of actual expenses against project budget
- Facilitate effective and open communications with all stakeholders
- Maintain and update a CMC risk register track action items against the identified risks and communicate/document status/resolution periodically and as needed
- Maintain and update internal integrated project plan and align with external partner deliverables with timely communication to all impacted stakeholders
- Support effective and efficient meetings and ensure timely communication with all required stakeholders on any key risks issues and planned changes to approved scope
Qualifications :
Requirements
- BS or MS or PhD in a relevant pharmaceutical sciences discipline with 26 years of relevant handson pharmaceutical/biotech industry experience in drug discovery and development
- Experience with crossfunctional team roles and responsibilities in pharmaceutical development with a track record of influencing and problem solving
- Awareness of ICH GMP quality systems and regulatory guidances that impact drug development
- Demonstrated experience managing CMC project deliverables and timelines to ensure the project remains on schedule and within agreed to scope
- Experience working with project management methodologies including crossfunctional project planning budget development/accruals assessment and project management software and visualization tools
- Proficiency working with Microsoft Project OneNote SharePoint Excel Word and PowerPoint. Experience with portfolio management software such as SmartSheets is desirable.
- Familiarity with stageappropriate CMC development strategies across preIND through NDA to commercial stages
- Familiarity with common issues and risks encountered during drug development and manufacturing
- Demonstrated ability to work independently efficiently and effectively in a collaborative fastpaced integrated multidisciplinary team environment
- Strong interpersonal skills and able to effectively lead/facilitate in environment with sitebased and remote team members
- Ability to quickly adapt and work with the team to find creative solutions to technical issues that arise
- Excellent oral and written communication skills. Succinct but thorough communication with attention to detail analytical/critical thinking and data organization presentation and inference
- Onsite in SSF preferred with remote work negotiable
Additional Information :
The anticipated salary range for candidates who will work in our South San Francisco location is between $103000$152000 The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc.
ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristics.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
