SUMMARY:

Clinical Laboratory & Biospecimen Management (CLBM) is a group within Strategic Research and Developmental Operations (SRDO) that provides effective and efficient vendor oversight (operational, contractual, financial) for central and specialty laboratories involved in all stages of BioMarin’s clinical trials.CLBM is comprised of four groups: 1.) Study Operations & Biospecimen Requests, 2.) Technology Operations, 3.) Vendor & Operational Performance Support and 4.) VendorSupport. CLBM ensures the ethical collection, analysis, and lifecycle tracking of human biospecimens to deliver timely data in support of clinical protocol timelines including but not limited to ROCTAVIAN and VOXZOGO.

The Associate Director – Biomarker Operations in CLBM is responsible for understanding thescientific strategy and implementation of biomarker assaysto support clinical programs and reports to the Director of CLBM. The Associate Director is a leadership position thathas extensive experience in the following areas: Biomarker/Diagnostic Assay Development and Analysis Expertise, Clinical Trial Operations, Procedures and Regulations, Biospecimen Management, Vendor Sourcing & Contracting, Informed Consent (ICF) Design & Interpretation, Central and Specialty Lab Testing and Management.

H/Sheis also akeycontributorto clearly define protocol requirements. Therefore, this individual will help identify, understand, and translate the scientific testing needs from a protocol to a laboratory SOW. Establishcross-functionalrelationships to clearlyunderstand the protocol strategy tosuccessfully execute on clinical trials,operationalimprovement,andchangeinitiatives that impact biomarker assays performed byeither centralor specialty laboratories.

CLBM’s Vendor Support group is responsible for working with Global Study Operations, Global Sourcing & Procurement, Business Operations, Clinical and Translational Sciences, Clinical Data Management, Legal, GCP Compliance, Quality, and research teams to ensure a smooth process flow for all biomarker-related activities. 

KEY RESPONSIBILITIES:

• Responsible for providing biomarker and diagnostic project management and operations leadership across multiple clinical programs after Research & Early Development (RED) colleagues define the scientific path forward
• Leads project initiatives and CLBM team meetings
• Develops organization SOPs and implements best practice documents as appropriate
• Supports the implementation and execution of the clinical biomarker and diagnostic strategy with central and specialty laboratories in early and late development programs once defined by RED and Clinical Development Team (CDT)
• Manages key biomarker timelines, budget, risk assessments and quality metrics during study startup, conduct and closeoutin close collaboration with RED colleagues
• Work effectively with procurement and scientific leads with vendor sourcing and selection process for new or existing central and specialty labs to execute contracts and statement of work to meet program deliverables
• Contributes to central lab setup and management throughout the course of a study
  • Participate in “virtual” and in-person operational visits, when scheduled
• Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are, processed, tested and data is reported to meet development timelines and specifications
• Works closely with data management to establish data collection and transfer specifications with testing vendors and local labs
• Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials
• Works with scientific stakeholders to identify innovative biospecimen collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards
• Collaborates with clinical development on site trainings for biomarker sample management logistics, sample and testing questions from sites, IRBs, and ethics committees
• Develops with CLBM and cross-functional staff presentations and presents biospecimen tracking/testing metrics at regular team meetings
• May work with scientific stakeholders to evaluate and implement new assays and relevant technology as required to meet clinical program timelines
• Manages relationships with internal and external partners to ensure on time and quality deliverables
• Mentors’ biomarker/biospecimen operations staff to ensure consistency and high standards across the organization
  • May be responsible for line management of one or more vendor and/or operations managers
• Provide guidance and/or act as primary point of contact for escalation for central and specialty laboratories addressing any biomarker operational questions/issues that may arise and liaise with individual or cross-functional teams for resolution
  • Review, access and escalate, when necessary, unresolved operational issuesto JOC and/or EOC Chair and other cross-functional teams, as needed
  • Participate in Study Execution Team (SET) and other cross functional meetings as an adhoc member throughout the life cycle of a clinical trial to provide input, if needed
• Identifies, develops, and implements risk mitigation strategies as needed across programs
• Perform steward duties for research requests to analyze biorepository specimens, if needed
  • Be the point of contact with research colleagues that have questions about availability and suitability for future research use of residual clinical biospecimens
  • Has a strong scientific background in a relevant field to appreciate biomarker discovery research topics that are relevant to review for future research
  • Participate in inquiries related to the appropriateness or integrity of biospecimens, work with CLBM Stewards on disposal requests as appropriate
• Ability to effectively and collaboratively work on global cross-functional teams
  

Qualifications

• Life Science degree in scientific, medical or healthcare area required. Additional qualifications: e.g. MS, PhD and/or project management certification desirable
• 12+ years of professional bench work experience in a clinical development, project management, biomarker/diagnostic laboratory and/or pharmaceutical or biotech R&D
• Direct line management experience
• Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP, In Vitro Diagnostic Regulation (IVDR) 2017/746, General Data Protection Regulation (GDPR)required
• Strong leadership and mentoring skills, with experience leading projects in a multi-function matrix environment
• Project management and/or program operations experience
• Knowledge of drug development and/or biomarker/diagnostic assay development and analysis is required
• Excellent written and verbal communication skills

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 124,600 to $ 187,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.