Senior Clinical Outsourcing Manager (Remote Eligible)
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Directs and coordinates all clinical outsourcing needs; including vendor identification and selection, Request for Proposal (RFP) and Bid Defenses, negotiating SOW and budgets including change orders, co-manage all outsourcing budgets, performance metrics, and vendor oversight/governance. Partners with Finance to provide screening information, work completed to date, current and estimated budget spend, study budget projections for new studies, etc.
Key Accountabilities / Core Job Responsibilities:
Lead vendor identification, evaluation, and selection activities for clinical development programs, including CROs and specialty service providers.
Develop and manage Requests for Information (RFIs), Requests for Proposals (RFPs), bid analyses, and vendor recommendation materials.
Lead contract, scope of work, and budget negotiations with clinical vendors to achieve operational, financial, and timeline objectives.
Manage vendor governance activities including performance reviews, issue escalation, scorecard metrics, and continuous improvement initiatives.
Partner cross-functionally with Clinical Operations, Finance, Legal, and Procurement to align outsourcing strategies with program and organizational priorities.
Evaluate vendor capabilities, operational risks, and pricing structures to support informed business decisions and effective resource planning.
Facilitate bid defense meetings, governance reviews, and supplier business reviews with internal stakeholders and external partners.
Oversee contract administration activities including change orders, purchase order management, reconciliation activities, and vendor payment tracking.
Support audit readiness activities and participate in internal and external audit processes related to vendor oversight and contracting practices.
Oversee CRO negotiation of site level budgets and CTAs.
Contribute to the development and enhancement of outsourcing processes, standards, templates, and operational best practices.
Qualifications/Skills:
Typically requires a bachelor’s degree in life sciences, business, or a related field; advanced scientific or business degree preferred.
Typically requires 7+ years of experience in the biotech or pharmaceutical industry, including significant experience in clinical outsourcing, vendor management, and contract negotiations.
Demonstrated expertise managing outsourcing strategies and vendor relationships across multiple phases of clinical development.
Strong understanding of clinical trial operations, drug development processes, and cross-functional clinical development activities.
Experience negotiating complex contracts, scopes of work, budgets, and change orders with CROs and clinical service providers.
Strong analytical, financial, communication, and stakeholder management skills with the ability to influence cross-functional teams and external partners.
Experience with clinical financial management activities including budgeting, accruals, forecasting, and vendor performance metrics preferred.
Salary Range: $155,000.00 to $202,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Apply To This Job
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Directs and coordinates all clinical outsourcing needs; including vendor identification and selection, Request for Proposal (RFP) and Bid Defenses, negotiating SOW and budgets including change orders, co-manage all outsourcing budgets, performance metrics, and vendor oversight/governance. Partners with Finance to provide screening information, work completed to date, current and estimated budget spend, study budget projections for new studies, etc.
Key Accountabilities / Core Job Responsibilities:
Lead vendor identification, evaluation, and selection activities for clinical development programs, including CROs and specialty service providers.
Develop and manage Requests for Information (RFIs), Requests for Proposals (RFPs), bid analyses, and vendor recommendation materials.
Lead contract, scope of work, and budget negotiations with clinical vendors to achieve operational, financial, and timeline objectives.
Manage vendor governance activities including performance reviews, issue escalation, scorecard metrics, and continuous improvement initiatives.
Partner cross-functionally with Clinical Operations, Finance, Legal, and Procurement to align outsourcing strategies with program and organizational priorities.
Evaluate vendor capabilities, operational risks, and pricing structures to support informed business decisions and effective resource planning.
Facilitate bid defense meetings, governance reviews, and supplier business reviews with internal stakeholders and external partners.
Oversee contract administration activities including change orders, purchase order management, reconciliation activities, and vendor payment tracking.
Support audit readiness activities and participate in internal and external audit processes related to vendor oversight and contracting practices.
Oversee CRO negotiation of site level budgets and CTAs.
Contribute to the development and enhancement of outsourcing processes, standards, templates, and operational best practices.
Qualifications/Skills:
Typically requires a bachelor’s degree in life sciences, business, or a related field; advanced scientific or business degree preferred.
Typically requires 7+ years of experience in the biotech or pharmaceutical industry, including significant experience in clinical outsourcing, vendor management, and contract negotiations.
Demonstrated expertise managing outsourcing strategies and vendor relationships across multiple phases of clinical development.
Strong understanding of clinical trial operations, drug development processes, and cross-functional clinical development activities.
Experience negotiating complex contracts, scopes of work, budgets, and change orders with CROs and clinical service providers.
Strong analytical, financial, communication, and stakeholder management skills with the ability to influence cross-functional teams and external partners.
Experience with clinical financial management activities including budgeting, accruals, forecasting, and vendor performance metrics preferred.
Salary Range: $155,000.00 to $202,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Apply To This Job