Associate Director/Director, Biomarker Operations bei Syndax Pharmaceuticals
Syndax Pharmaceuticals · New York, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in New York
Syndax Pharmaceuticals is looking for an Associate Director/Director, Biomarker Operations
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
The Role:
This individual will play a critical role in supporting multiple clinical trials and managing and meeting timelines for PK and Translational biomarker deliverables. The successful candidate will demonstrate a proven track record in managing specialty lab vendors including central lab, clinical samples, and day-to-day operations including working closely with Syndax Clinical colleagues.
Key Responsibilities:
- Lead and Manage the Biomarker Ops group to develop and align on priorities, timelines, deliverables, and communications for implementing Translational Biomarker Plans for all trials across the Rev portfolio
- Manage weekly/daily operational activities around central and specialty labs to facilitate start-up activities and readouts on Phase 1-3 Trials
- Act as central support for clinical team and serve as primary contact for sites and clinical CROs relating to kitting, clinical sample collections and handling
- Author relevant sections of Lab manuals and SOPs pertaining to sample collections, processing, and handling of patient samples
- Initiate and finalize contracts/SOWs, manage vendors and POs, approve invoices for each study, in support of study or research objectives and translational biomarker goals
- Work with relevant internal teams and external vendors to assist with the coordination of data and sample analysis, data transfers, data reconciliation, and data review
- Monitor and report on key deliverables and timelines associated with partner labs or CROs responsible for sample handling or analysis
- Participate in CTWGs and maintain active communication with clinical operations colleagues regarding progressing study objectives and activities on trials
- Manage Managers, resources, and workload of Biomarker Ops group
- Work with IT and DM to develop and manage comprehensive internal databases of Biomarker Sample Inventories and Data to facilitate Translational analyses and research collaborations
- Maintain repository of Translational Biomarker Assay documents related to validation reports, SOPs, vendor contracts, sample requirements, assay costs and utility for all trials
- Work with Translational colleagues to manage priorities, timelines, and outputs for external research collaborations
- Identify and coordinate shipment of appropriate samples to vendors/collaborators for internal and external research studies
- Maintain communications with vendors/collaborators to manage sample expectations, data transfers/outputs, and goals of study
Desired Experience/Education and Personal Attributes:
- Degree in life sciences or related field preferred
- 8+ years of experience in biomarker operations, clinical sample management, or translational research in a biotech/pharma setting
- Proven track record in managing specialty lab vendors and clinical sample logistics
- Strong understanding of clinical trial processes, GCP, and regulatory requirements
- Excellent project management, organizational, and communication skills
- Experience with database systems for sample tracking and data management is a plus
- Leadership experience with direct reports and cross-functional teams
Location: Syndax’s corporate office is in New York, NY.
Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $185,000 - $230,000.
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.
Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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