Senior Manager, Clinical Outsourcing & Business Operations (Central & Specialty Labs)
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
Reporting to the Sr. Director of Clinical Outsourcing and Business Operations (COBO), the Sr. Manager Clinical Outsourcing and Business Operations is accountable for successful execution of outsourcing and business operations processes within the development operations group including, but not limited to, strategic outsourcing, vendor management and contract and budget negotiations. It’s highly preferred that this candidate has deep knowledge and experience with Central Labs, Specialty Labs, and BioAnalytical labs.
- Manages the identification and selection process of clinical vendors such as CROs, central labs, Imaging, data management, biostatistics, etc.
- Generates Requests for Information (RFI) and Requests for Proposals (RFP) and budget grids
- Coordinates bid defenses and proposal review meetings and provides analysis to project teams
- Manages operational aspects of clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets
- Ensures quality oversight of vendors by:
- Partners with suppliers and internal staff to identify, manage, escalate and resolve issues related to supplier performance;
- Measures supplier performance utilizing Scorecard/Metric activities; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements/ maintenance;
- Facilitates and executes supplier governance meetings and operating reviews;
- Develops effective partnerships with suppliers and internal staff.
- Thorough understanding of vendor contracts, contract types and the ability to negotiate budgets
- Support Quarterly Variance Analysis process for clinical study vendor contracts
- Participate in the preparation and presentation of internal reports to management and other various business end users
- Support Purchase Order management and contract/account reconciliation
- Support quarterly external auditor reviewers and annual audits
- Manage Clinical Consultant agreements and clinical Business Operations procedures
- Deep knowledge and understanding of Central Labs, Specialty Labs and BioAnalytical Labs - this individual will be the Subject Matter Expert (SME) partnering with the key stakeholders in this area (Preferred) along with leading key programs/studies within the Denali portfolio.
- BS or BA, MS, Ph.D, or PharmD.
- 4+ years in biotech/pharma clinical research industry; 3-5 years’ clinical outsourcing and business operations experience – Must have good knowledge of the clinical vendor landscape.
- 4+ years of experience in the central lab, specialty lab and bioanalytical area (preferred)
- Expert in outsourcing and contracting best practices for all phases of clinical research with an understanding of the drug development process and the cross-functional responsibilities including clinical trial design, study start-up and execution, CRA and site management, safety reporting, data management, and biometrics
- In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating SOW terms, and growing and fostering long-term, healthy strategic relationships
- Strong understanding of the drug development process and the cross-functional responsibilities including: clinical trial design, study start-up and execution, site management, safety reporting, data management, and biometrics.
- Strong interpersonal, communication and presentation skills to be able to engage with all levels both within Denali Therapeutics and entities and with our CRO and clinical service providers.
- Forward-thinking and creative with high ethical standards.
- Understanding of clinical financials a plus (i.e. budgeting, accruals and forecasting)
- Ability to work in a fast-paced environment with drug development professionals.
- Strong problem-solving skills.
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.
Salary Range: $159,000 to $192,333. 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.