CAMILO ASUNCION
San Mateo,CA
Summary
A dynamic and agile biotech leader with extensive experience in sourcing, global outsourcing, vendor lifecycle management, people management, headcount planning and utilization, clinical finance, contracts and contract lifecycle management. Ability to adapt or generate new ideas, strategies, and business processes to seamlessly integrate within a current or future business model, execute and deliver.
Overview
25
25
years of professional experience
Work History
Clinical Outsourcing and Business Operations Consultant
Independent | Various Sponsors and Vendors
San Mateo
04.2024 - Current
- Lead and support all the clinical outsourcing needs which are determined by the sponsor or vendor; including vendor strategy and landscape assessment, vendor identification and selection, leading the RFx process through final selection, facilitate bid defenses and provide budget, quantitative and qualitative assessments to support the overall vendor selection process (aligning with internal GxP requirements)
- Negotiate the business terms and conditions within an MSA, clinical vendor contracts or change orders which include the SOW, budget and preferred discounted terms
- Assess and implement the appropriate level of oversight or governance to meet GxP needs
- Additionally, incorporate key level metrics and KPIs to help manage the vendors overall performance
- Business operations - Provides high level guidance and support related to clinical financials (i.e accruals, BVA analysis, budget management, etc.), resource utilization and day to day operations (upstream and downstream)
- Negotiate US CTA budgets with support from the sponsor or CRO
Sr. Director, Head of Clinical Outsourcing and Business Operations
Denali Therapeutics
S. San Francisco
10.2019 - 02.2024
- Directs and manages a team that drives and coordinates all clinical outsourcing needs; including vendor identification and selection, Request for Proposal (RFP) and Bid Defenses, negotiating SOW and vendor budgets including change orders, vendor management, performance metrics and implementing the appropriate level of vendor oversight or governance
- Oversees and accountable for clinical finance activities which includes vendor accruals, clinical budget modeling, quarterly rolling forecasting, BVA analysis and long-range planning
- Drives the resource planning activities for most of the Development organization and help to create functional specific FTE models to assess overall demand against the portfolio
- Partner with finance to meet month end close requirements in addition to ad-hoc support with accounting to accommodate requests from Denali auditors
- Leads a high performing team with strong people management skills that include and is not limited to mentoring and alignment of their development to Denali or Development wide goals
- Led and supported the outsourcing, contract and budget needs of various cross functional Development groups (i.e
- Medical Affairs, Regulatory and Clinical QA, Biometrics, etc.).
Strategic Clinical Outsourcing Consultant
GForce Life Sciences | Calico
S. San Francisco
03.2019 - 10.2019
- Provide clinical outsourcing and vendor strategy guidance to support Calico's clinical development plan
- Responsibilities include but are not limited to identification, bid coordination, due diligence assessment of potential vendors that could support Calico's clinical development program needs.
Strategic Partnerships and Sourcing Consultant at Verily
GForce Life Sciences | Verily Life Sciences
S. San Francisco
10.2018 - 03.2019
- Partner with Clinical, Legal, Finance, Program Management and other cross functional areas to ensure that high quality contracts and commitments are negotiated and created to optimize the future commercial interests of the business
- Partner with the expertise areas in the organization to develop a robust performance and relationship management program
- Help build & support the alliance management program with CRO partners and manage an efficient partner/supplier selection process driving the team towards a timely decision with all risks identified
- Negotiate master agreements as well as other associated contracts and detailed budgets and payment schedules
- Constantly evaluate the marketplace for new suppliers and services and maintain knowledge of supplier technical capabilities, compliance status, and financial solvency.
Head of Contracts and Business Management
Juno Therapeutics
Brisbane | S. Lake Union, WA
10.2017 - 08.2018
- Develop strategies and infrastructure to ensure optimization of business expertise and delivery to the business while contributing to the management, leadership, delivery and oversight of contracts/budgets/vendor management
- Partner with the VP of Clinical Operations in developing and implementing strategic vision for the group and assess over time
- Evaluates business needs of the organization, provides recommendations and sets priorities
- Successfully launched Juno's first outsourced trials with a CRO and established governance to measure overall performance and manage the relationship
- Understands Juno portfolio and book of business and ensures agility and preparedness of team to meet the delivery demands of the Clinical Operations organization
- People management (team of three) which includes development and performance management.
Head of Contracts Management
Genentech - A Member of the Roche Group
S. San Francisco
08.2016 - 10.2017
- Accountable for ensuring compliance with Fair Market Value, Sunshine Act, and SOPs related to contracts and invoicing
- Responsible for the strategic direction of the team, which is responsible for contract, financial planning and management, analytics, annual and individual advisory board process management and financial planning
- Provide recommendations to Head of MBO for efficiency and continuous improvement, technical and process enhancements and to ensure excellent business partnering and customer service to USMA Medical Units
- People management (team of six) which includes development and performance management.
Portfolio Execution Manager, gRED
Genentech - A Member of the Roche Group
S. San Francisco
04.2014 - 08.2016
- Successfully lead and implemented new contract model and process under new gRED strategic alliance (i.e
- Budget model, contract templates, etc.)
- Chaired the C&O resource committee and drives validation and requests for resources in collaboration with the management team
- Ensures individualized sourcing support is provided to gRED which meets the business need, builds on existing experience whilst capitalizing on opportunities for innovation both for the gRED business partner as well as for the whole Roche portfolio
- People management (team of eight) which includes development and performance management.
Functional Manager, Product Development (PD)
Genentech - A Member of the Roche Group
S. San Francisco
03.2013 - 04.2014
- Co-led a global cross-functional Roche initiative that revised the Service Provider Management and Outsourcing SOP
- Contributes to development of C&O specific resources algorithm and resource allocation
- People management (team of eight) which includes development and performance management
- PD Therapeutic Area Single Point of Contact (SPOC) for Immunology, Infectious disease, Ophthalmology, and Oncology (lung/heme/skin)
- Successfully identified and implemented a new CRO costing tool to the Outsourcing group and lead the implementation and training to the business.
Clinical Outsourcing Manager | Business Manager
Genentech - A Member of the Roche Group
S. San Francisco
06.2006 - 02.2013
Clinical Services Manager
Amylin Pharmaceuticals
San Diego
04.2002 - 06.2006
Sr. Project Financial Analyst
Quintiles Transnational
San Diego
05.1999 - 04.2002
Education
Business Administration And Management (BSBAM)
University of Redlands
Redlands, CA06.1999
Skills
- Sourcing and Global Outsourcing
- Vendor and Category Management
- Leadership and People Management
- Contract Lifecycle Management
- Vendor Relationship and Performance Management
- Clinical Financials, Budget, Forecasting, BVA analysis and FTE demand assessment
- Contract and Budget Negotiation
- Process Management and Continuous improvement
- GxP vendor qualification and oversight
Accomplishments
April 2008 | CRO Partnerships Conference | Las Vegas, NV
- Panel presentation on “Introduction to Clinical Trial Finance: Fundamentals of Costs and Budgets”
March 2009 | Recognition Award | Roche-Genentech
- Projects/Process Innovation
- Led the evaluation, validation, integration, and training of an external costing tool that was brought in house to address a critical business need within clinical operations and outsourcing (CRO/niche service provider ballpark estimating). Also implemented and created a new process to streamline and make this effort much more efficient.
August 2016 | Certificate of Completion | Roche-Genentech
- Lean Six Sigma White Belt Training
Timeline
Clinical Outsourcing and Business Operations Consultant
Independent | Various Sponsors and Vendors
04.2024 - Current
Sr. Director, Head of Clinical Outsourcing and Business Operations
Denali Therapeutics
10.2019 - 02.2024
Strategic Clinical Outsourcing Consultant
GForce Life Sciences | Calico
03.2019 - 10.2019
Strategic Partnerships and Sourcing Consultant at Verily
GForce Life Sciences | Verily Life Sciences
10.2018 - 03.2019
Head of Contracts and Business Management
Juno Therapeutics
10.2017 - 08.2018
Head of Contracts Management
Genentech - A Member of the Roche Group
08.2016 - 10.2017
Portfolio Execution Manager, gRED
Genentech - A Member of the Roche Group
04.2014 - 08.2016
Functional Manager, Product Development (PD)
Genentech - A Member of the Roche Group
03.2013 - 04.2014
Clinical Outsourcing Manager | Business Manager
Genentech - A Member of the Roche Group
06.2006 - 02.2013
Clinical Services Manager
Amylin Pharmaceuticals
04.2002 - 06.2006
Sr. Project Financial Analyst
Quintiles Transnational
05.1999 - 04.2002
Business Administration And Management (BSBAM)
University of Redlands