The candidate will be a key leader within Program Management, and support CMC (Chemistry, Manufacturing and Control) projects and information management for one or more of the small molecule programs within Nurix development portfolio.
In this newly created position, the CMC Project Manager will be responsible for providing consistent project status to internal and external stakeholders for CMC projects within the Nurix portfolio, and ensuring integration and alignment into overall program timelines. Reporting to the VP Program Management and Asset Strategy, the leader in this role will partner internally with cross-functional stakeholders, and externally with contracted vendor organizations (for example: contract development and manufacturing organizations, CDMO’s). The individual will work closely with the development and clinical supply teams for one or more projects: to develop, update and optimize CMC project plans, facilitate and lead formal and informal communication internally and with external partners, and promote an environment of efficient, visible, execution that includes optionality as challenges arise.
- Coordinates the design and execution of cross-functional CMC project plans for early clinical development to commercial readiness for small molecule therapeutics.
- Maintains frequent communication with the cross-functional CMC project team members and key internal stakeholders so that all parties are aware of current project status, issues, contingencies, and milestones.
- Proactively identifies CMC critical path, risks and impediments to successful development and drives the identification and development of solutions to mitigate these risks.
- Prepares summary information on CMC project progress, timeline updates and risk assessment for integration into Early Development Teams and overall program timelines; periodic presentations to program oversight committees.
- With team members and in accordance with corporate objectives, facilitates the setting of program CMC strategy and objectives, key milestones and scope.
- Leads CMC team meetings and ensures that clear agendas are set, and actions and decisions are documented, communicated and committed to, enabling timeline achievement
- Builds strong working relationships across departments, with key stakeholders to ensure transparency and to facilitate communication.
- Establishes project management best practices and assists in the implementation of infrastructure necessary for successful project management such as the preparation of SOPs relating to written processes and procedures and the establishment of electronic document standards.
In addition to the CMC Project Manager responsibilities, Sr. Manager responsibilities will include:
- Independently develops the project plan based on work breakdown structure.
- Serves as the primary point of contact for CMC project management activities internally and externally.
- Supports discussions regarding clinical and commercial supply agreements. Support sourcing process as needed.
- Assesses CMC project performance using appropriate tools and techniques and identifies/quantifies any variances to the approved CMC project plan
- Performs other duties as assigned
- Minimally, a B.S. degree in life sciences, chemistry, engineering or equivalent
- A minimum of 5 years as a contributor for a technical program related to biotech, pharmaceuticals, or materials manufacturing as a contributor and at least 5 years as a leader/manager
- Extensive intermediate to advanced computer skills (Power Point, excel, Work, MS Project, SharePoint)
- Demonstrated track record providing strategic and tactical support to development and supply chain functional groups within a company
- Experience working with CMC Teams and managing relationships with CMOs/CROs, preferred
- In-depth knowledge of the pharmaceutical industry and drug development and approval process a significant plus
- Early stage clinical development and IND experience is preferred; late stage development and commercial readiness a plus.
- Strong organizational, communication (verbal and written) and forecasting skills
- Confident and respectful when interacting with all levels of management: stays focused and on-point, and raises problems or challenges in a productive, solution-minded manner
- Diplomatic and calm under pressure; able to deal with uncertainty in a constructive manner and generate options for moving forward
- Unquestionable ethics and integrity
- Excellent interpersonal skills including people management, time management, and prioritization
- Proven ability in negotiating/influencing and collaboration
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.
Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.