Associate Director, Outsourcing and Vendor Management
Clinical Operations | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Position: Associate Director, Outsourcing and Vendor Management
The Associate Director, Outsourcing and Vendor Management will be responsible for leading outsourcing activities for Research & Development (R&D) related to vendors and clinical trial sites. This individual will also be the primary departmental liaison with FP&A and legal and support accruals management, PO and budget oversight. The successful candidate will develop the vendor oversight strategy for the department and partner with key stakeholders across programs to ensure successful identification, selection and maintenance of vendors, consultants and site contracts. This individual would be responsible for managing third-party relationships and developing best working practices for vendor interaction, pricing, and negotiations.
The selected candidate must be hands-on and comfortable developing procedures, templates, and relationships.
- Lead and manage vendor selection process including preparation of RFIs and RFPs
- Act as a liaison for vendor qualification; ensure that sponsor obligations for vendor selection and qualification are followed, including vendor audits, as applicable
- Build cross-functional relationships with Finance, Legal, and project teams for all scope of work change requests, contract negotiation, and creation of standard budget and SOW templates
- Negotiate and manage new vendor budgets and SOWs; negotiate and manage change control process, including changes in SOWs and budgets
- Collaborate with Business Owners, vendors and Finance to track purchase orders and current spend, vendor accruals, and projections; and update vendor budget information for annual budget and long-range planning processes
- Track vendor contract timelines; initiate renewal process as needed
- Ensure completion of vendor close-out activities and final financial reconciliation at end of engagement
Clinical Trial and Site Budgets
- Oversee creation and management of site budgets and development of strategic clinical site collaborations
- Approve clinical site contract and budget negotiating parameters for CROs
- Develop cost estimates for study scenarios, forecast full study budgets and keep them up-to-date, working closely with each clinical trial manager; assist clinical trial managers with preparing accruals
- Oversee and lead supplier governance activities; coordinate executive oversight meetings and monitor key performance indicators (KPIs) and performance metrics; facilitate early escalation of cross-functional vendor issues; partner with study teams to create and manage risk mitigation plans or corrective action plans for vendor performance or quality issues
- Create and define overall outsourcing strategy, including potential preferred provider relationships, negotiated rate cards, volume discounts, etc.
- Create and maintain outsourcing/vendor oversight standards and templates
Other Duties as assigned
- Bachelor's degree with at least 8-10 years of experience with a focus on developing and overseeing budgets and contracts with clinical outsourcing vendors in the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered). Advanced degree in life science and/or MBA strongly preferred
- At least 3 years of direct clinical trial and/or vendor oversight experience required; experience negotiating, administering, extending, terminating, and re-negotiating contracts
- Advanced negotiation skills and vendor selection experience
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
- Excellent written and verbal communications skills
- Ability to influence without direct authority and creating strong relationship and partnership with vendors and collaborators
- Results-driven with demonstrated successful outcomes with experience managing regulatory inspections
- Ability to handle multiple tasks and priorities in a fast-paced environment with awareness of deadlines
- Proficient in the use of Microsoft software and development of tracking tools
- Ability to identify processes needing improvement, and to recommend improvements
- Working knowledge of various contract types and complexity levels
- Knowledge of clinical development financial principles including cash flow neutrality, payment schedules, costing systems, relational costs
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Candidates must be authorized to work in the U.S.
- Responsibility, accountability, and ownership – The ability to work independently and drive solutions
- Communication and Teamwork - The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals
- Effective Planning - Embedding discipline and thoroughness in our approaches
- Risk and Compliance Management - Demonstrates great attention to detail and assures appropriate output. Identifies situations where risk may arise and implements risk mitigation processes and strategies
- Adaptability/Flexibility - The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
- Leverage Systems & Technology - Uses systems and technology in a facile way. Identifies opportunities to improve processes through systems and technology
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.