CrawlJobs Logo

Senior Manager, Clinical Biomarker Operations

apogeetherapeutics.com Logo

Apogee Therapeutics

Location Icon

Location:
United States , Boston

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

160000.00 - 175000.00 USD / Year

Job Description:

The Department of Research and Translational Medicine is seeking a Sr. Manager, Clinical Biomarker Operations. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, contracts, and budget management.

Job Responsibility:

  • Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition
  • Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications
  • Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions
  • Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance
  • Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships
  • Support QA in vendor audit and inspection activities
  • Support activities related to biomarker budget planning and tracking of accruals
  • Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards
  • Continuously identify and build best practices for process improvements
  • Ensure high quality data generation by overseeing sample integrity and external collaborations

Requirements:

  • MS or higher with > 3 years or BS with >5 years of direct experience in biomarker operations role
  • Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage
  • Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking, and final reconciliation of activities
  • Experienced in all phases of clinical trials, Phase 3 experience is an asset
  • Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays, and drug development in general
  • High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines
  • Experience in I&I indications
  • Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines
  • Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Ability and willingness to travel, including a minimum of ~4 times per year for All Hands meetings and other workshops
  • This position requires direct biotech or pharmaceutical industry experience. Do you have at least 4 years of experience working in a biotech or pharmaceutical company?
What we offer:
  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve

Additional Information:

Job Posted:
January 19, 2026

Employment Type:
Fulltime
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Manager, Clinical Biomarker Operations

New

Senior Manager Clinical Operations and Strategic Alliances

The Sr. Manager, Clinical Operations and Strategic Alliances reporting to the Di...
Location
Location
United States , Pleasanton
Salary
Salary:
173100.00 - 234100.00 USD / Year
10xgenomics.com Logo
10x Genomics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • An Advanced degree (M.S., PharmD, Ph.D., M.B.A.) in a Life Science, Clinical, or related field is required
  • 8+ years of relevant industry experience with 4-5 years of experience in Clinical Operations and Alliance / Program Management within the diagnostics, biotechnology, or pharmaceutical industry
  • Direct experience managing research studies involving large numbers of patient samples and complex molecular testing or biomarkers
  • Deep understanding of clinical study execution, site management, and the complexities of clinical sample logistics and chain of custody
  • Direct experience in managing high-value strategic alliances and driving value through the successful execution of collaborative research, development, or commercialization agreements
  • Demonstrated ability to manage competing priorities, swiftly resolve complex operational problems, and drive tangible results
Job Responsibility
Job Responsibility
  • Study Execution: Manage the operational execution of large-scale, longitudinal clinical research studies according to established agreements with academic institutions
  • Timeline & Risk Management: Own and drive clinical research study timelines, deliverables, and operational plans ensuring adherence to sampling schedules
  • identify operational risks regarding enrollment, setup, or logistics early, implementing mitigation strategies to maintain study integrity
  • Sample Logistics & Chain of Custody: Establish and enforce auditable procedures for sample collection, tracking, and chain of custody, ensuring compliant transport from clinical sites to 10x Genomics laboratory
  • Budget & Resource Oversight: Manage the study budgets, including the oversight of reimbursement, equipment provisioning, and consumables provided to partner sites
  • Regulatory & Quality Compliance: Ensure all study activities comply with IRB protocols, patient consent requirements, and GCLP/CLIA standards where applicable
  • Partnership Management: Manage a diverse, high-value portfolio of academic collaborations and strategic partnerships to ensure all projects and agreements track toward established milestones and outcomes
  • Governance Management: Ensure transparent communication, effective decision-making, and rapid conflict resolution between internal teams and external partners
  • lead and facilitate Joint Steering Committees (JSCs) and cross-functional governance meetings as needed
  • Stakeholder Management: Act as the primary liaison between internal teams and key stakeholders at relevant academic institutions and industry partners to foster strong, collaborative relationships that drive engagement and performance
What we offer
What we offer
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Easy-to-use benefits that promote wellbeing and make your life easier
  • Family friendly policies like parental leave
  • Award-Winning Workplace
  • Fulltime
Read More
Arrow Right

Oncology Early-Stage Clinical Scientist

You will lead and coordinate the development of multiple studies of novel biolog...
Location
Location
United States , Cambridge; La Jolla; Bothell; Groton; New York City
Salary
Salary:
176600.00 - 282900.00 USD / Year
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO
  • MS and a minimum of 7 years of experience in a similar role in industry/CRO
  • BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
  • Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
  • Experience in or strong understanding of Oncology Drug Development especially in Early Development
  • Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
  • Strong scientific writing skills and communication skills (written and verbal)
  • Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
  • Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
  • Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance
Job Responsibility
Job Responsibility
  • Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
  • Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
  • Support execution for all FIH programs through proof-of concept
  • Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends
  • review and query data
  • present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
  • Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics
  • Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
  • Support and assist in the development of publications, abstracts, and presentations
  • May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials
What we offer
What we offer
  • Eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
  • Eligibility to participate in our share based long term incentive program
  • 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
  • Paid vacation, holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits to include medical, prescription drug, dental and vision coverage
  • Relocation assistance may be available based on business needs and/or eligibility
  • Fulltime
Read More
Arrow Right

Clinical Quality Compliance Senior Manager

The role provides proactive end to end quality support for the development and i...
Location
Location
Türkiye , Istanbul
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of Quality Management, Quality Assurance and Good Clinical Practices experience in the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility
  • Master’s degree and 4 years of the previous mentioned experience
  • Bachelor’s degree and 6 years of the previous mentioned experience
  • Associate’s degree and 10 years of the previous mentioned experience
  • Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
  • Thorough understanding of Clinical R&D activities and Global Regulations
  • Experience with Regulatory Submission and Inspection Management procedures
  • Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
  • Leadership or mentoring experience is ideal, in a regional capacity would be phenomenal
  • Excellent verbal and written communication skills, including strong business writing abilities and active listening
Job Responsibility
Job Responsibility
  • Act as a Good Clinical Practice (GCP) Subject Matter Expert, offering independent, objective quality guidance
  • Oversee quality across all clinical development stages
  • Plan and execute risk-based GCP audits (sites, affiliates, vendors, studies)
  • Support regulatory inspections and guide responses, including root cause analysis and CAPAs
  • Lead quality oversight of Risk Assessment Categorization Tools (RACT) for each trial
  • Facilitate monthly quality risk reviews with clinical program leaders
  • Manage audit findings, deviations, and CAPA responses
  • Ensure regional compliance with local regulations and support vendor evaluations
  • Analyze data quality trends, identify gaps, and implement corrective actions
  • Oversee technologies for endpoint data collection (e.g., biomarkers, imaging)
What we offer
What we offer
  • Vast opportunities to learn, develop, and move up and across our global organization
  • Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
  • Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits
  • Flexible work arrangements
Read More
Arrow Right

Senior Director Immunology

The Senior Director Immunology will lead discovery, preclinical development, and...
Location
Location
United States , Sioux Falls
Salary
Salary:
Not provided
SAB Biotherapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD with 10+ years’ experience in Immunology or related field, with biotech/pharma industry experience required
  • Deep expertise in immunology, T-cell biology, autoimmune mechanisms, and therapeutic antibodies
  • Proven proficiency in clinical immunophenotyping, particularly advanced flow cytometry
  • Strong record of accomplishment in advancing immunology-focused therapeutics and leading translational/biomarker initiatives
  • Experience managing laboratory scientists and analytical teams
  • Skilled in molecular and cellular assay development within industry settings
  • Familiarity with global regulatory pathways (FDA, EMA, MHRA, TGA)
  • Highly collaborative, innovative, with strong written and spoken communication skills and ability to lead in a matrixed, distributed environment
  • High level of emotional intelligence and the demonstrated ability to be an effective listener with strong diplomacy and presentation skills
  • Previous experience meeting with and presenting to internal and external stakeholders to include, but not limited to BOD, investors, analysts and at industry conferences
Job Responsibility
Job Responsibility
  • Oversee the design, execution, and validation of biomarker discovery, flow-based immunophenotyping, and patient-stratification assays for clinical trials
  • Direct experimental planning and data analysis, ensuring high-quality data interpretation, reporting, and communication to internal stakeholders and governance bodies
  • Partner with translational, clinical, regulatory, and development teams to integrate biomarker and assay strategies into protocols, regulatory documents, and clinical plans
  • Provide strategic leadership across Research and Translational Immunology, guiding disease biology insights, mechanism-of-action studies, and biomarker-enabled clinical strategies
  • Participate in translational and biomarker planning for discovery through clinical stages, including immunophenotyping, pharmacodynamic analyses, and molecular/cellular profiling
  • Manage and collaborate with CROs, external vendors, and academic partners to support assay development, method innovation, and data generation
  • Foster an excellent research environment, supporting lab-based teams in culture, collaboration, operations, and safety
  • Represent Translational Science and Immunology internally and externally, presenting scientific findings and program progress. This includes presenting to investors, analysts and at industry conferences
  • Identify and pilot innovative technologies to enhance translational science and immunotherapy development
  • Ensure compliance with global regulatory standards (FDA/CBER, EMA, MHRA, TGA) and maintain awareness of scientific and technical advancements relevant to autoimmune drug development
  • Fulltime
Read More
Arrow Right

Quality Compliance Senior Manager

The role provides proactive end to end quality support for the development and i...
Location
Location
Türkiye , Istanbul
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of Quality Management, Quality Assurance and Good Clinical Practices experience in the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility
  • Master’s degree and 4 years of the previous mentioned experience
  • Bachelor’s degree and 6 years of the previous mentioned experience
  • Associate’s degree and 10 years of the previous mentioned experience
  • Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
  • Thorough understanding of Clinical R&D activities and Global Regulations
  • Experience with Regulatory Submission and Inspection Management procedures
  • Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
  • Leadership or mentoring experience is ideal, in a regional capacity would be phenomenal
  • Excellent verbal and written communication skills, including strong business writing abilities and active listening
Job Responsibility
Job Responsibility
  • Act as a Good Clinical Practice (GCP) Subject Matter Expert, offering independent, objective quality guidance
  • Oversee quality across all clinical development stages
  • Plan and execute risk-based GCP audits (sites, affiliates, vendors, studies)
  • Support regulatory inspections and guide responses, including root cause analysis and CAPAs
  • Lead quality oversight of Risk Assessment Categorization Tools (RACT) for each trial
  • Facilitate monthly quality risk reviews with clinical program leaders
  • Manage audit findings, deviations, and CAPA responses
  • Ensure regional compliance with local regulations and support vendor evaluations
  • Analyze data quality trends, identify gaps, and implement corrective actions
  • Oversee technologies for endpoint data collection (e.g., biomarkers, imaging)
What we offer
What we offer
  • Vast opportunities to learn, develop, and move up and across our global organization
  • Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
  • Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits
  • Flexible work arrangements
  • Fulltime
Read More
Arrow Right

Clinical Study Team Assistant

As a part of the global Project Leadership group at Parexel, you are responsible...
Location
Location
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree (B.S. or B.A.) in either a Scientific or Business-related field preferred or equivalent relevant experience
  • Minimum 2 - 3 years experience in clinical administration in pharmaceutical or clinical research environment
  • Solid experience in TMF
  • Experience in WORD, EXCEL, PowerPoint, other software and system
  • Fundamental understanding of filing systems and organizational tools
  • Proficiency in written and spoken English
  • Able to independently prioritize multiple key activities, collaborate effectively with various levels of seniority on the study team and across the organization and efficiently ensure completion of tasks per timelines to required quality standards
  • Able to work independently and proactively to anticipate team needs related to clinical trial services
  • Demonstrated effectiveness working with multiple functions in a professional manner
  • Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
Job Responsibility
Job Responsibility
  • Provide Client Trial Master File (TMF) support and maintenance – file & ensure documents are in the TMF
  • Input into the set- up of TMF document list and maintains relevant clinical trial documents according to International Conference on Harmonization-Good Clinical Practices (ICH-GCP) and Standard Operation Procedures (SOPs), including archiving and electronic filing of documents (TMF)
  • Accountable for analyzing, interpreting and evaluating clinical trial documentation to determine appropriateness for inclusion into the TMF
  • Evaluate TMF compliance and raise findings to Study Manager (SM)
  • Files and tracks documents for the study in collaboration with the document owner
  • Collaborates with the TMF Study Owner for issues or problems to be addressed and to create and manage placeholders
  • Ensures resolution of Quality Control (QC) findings (as delegated) to support final archive of the clinical study documents
  • Maintain, verify, process, and makes updates to Client systems (including Registry), spreadsheets/documents as needed
  • For Early Development and some small/single country studies may be required to: Coordinate Clinical Study Agreement approvals to ensure timely site initiation
  • Responsible for coordinating the clinical trial application to ethics committee and regulatory authority
What we offer
What we offer
  • Supportive work environment
  • High degree of empowerment and accountability
  • Work with a diverse set of clients and therapeutic areas
  • Encouraged to take on new challenges and pursue your interests
  • Supportive and inclusive environment
  • Flexible work arrangements
  • Remote, in-office and hybrid roles
  • Varied project experience
  • Career progression
  • Fulltime
Read More
Arrow Right

Japan Clinical Leader

Responsible for clinical development of the assigned project in Japan under the ...
Location
Location
Japan , Tokyo
Salary
Salary:
Not provided
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Scientific background in education
  • >3 years or more experience in clinical development
  • Experience in clinical development
  • Thorough understanding of the processes associated with clinical and regulatory submissions
  • Skill to design and execute development strategies (e.g. advanced medical and pharmaceutical knowledge, skill to design development strategies, knowledge on clinical study operations including guidelines and SOPs, skill to think logically, innovatively, and flexibly, writing skills)
  • Leadership skills
  • Team building skills, networking skills
  • Negotiation skills, consensus building skills
  • Problem solving skills
  • Project management skills
Job Responsibility
Job Responsibility
  • Evaluate candidates for development in the assigned TA/DA from scientific and technical aspects and formulate an effective development plan for Japan with the JDL and the global team
  • Contribute to establishing the global development plan by discussing points to consider in developing the product (including biomarkers and diagnostics) and obtaining approval in Japan (e.g. medical practice, communication with the government) with the global team and considering strategies towards early launch
  • Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group] to enhance the possibility of expedited development and early approval with the JDL and senior JCL
  • Lead Japan Development Team (JDT) and clinical studies of assigned project to success in cooperation with JDT and global team members
  • Communicate closely with the GCL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU) and build and execute an effective development strategy
  • Prepare high quality documents (e.g.study outline, briefing document, CTD, query response, publications) and review them
  • When a Clinical Scientist (CS) is assigned to the project, review the documents prepared by the CS (e.g. full protocol, informed consent document, investigator's brochure)
  • when a CS is not assigned, the JCL is responsible to prepare and review these documents
  • Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval
  • Review clinical data and protocol deviations and determine necessary actions for clinical studies in which he/she is the Clinical Lead
  • Fulltime
Read More
Arrow Right

Associate Director Medical Writer

The Associate Director Medical Writer is an individual expert who can manage and...
Location
Location
Canada , Mississauga
Salary
Salary:
Not provided
us.gsk.com Logo
GSK
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD or relevant working experience within the life sciences space
  • Proven track record in writing clinical/regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
  • Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements
  • Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide
  • Demonstrated effectiveness in management of projects of increasing scope and complexity
  • Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
  • Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions
  • High-level computer skills and general computer literacy
  • Demonstrated knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
  • Ability to interpret clinical data, assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents
Job Responsibility
Job Responsibility
  • Contribute to the planning, authoring, review, and approval of clinical/regulatory documents for medical writing project to achieve a successful outcome within the required timelines
  • Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level
  • Provide major input to submission teams in development of submission plans, timelines, document content and dependencies
  • Advises on or recommends methods for achieving accelerated timelines, including review tools and automation
  • Actively contribute to development of training materials for clinical document preparation
  • provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
  • Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
  • Effectively contribute to process improvement activities
What we offer
What we offer
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Fulltime
Read More
Arrow Right