Director, Clinical Laboratory & Biospecimen Management

Company: BIOMARIN
Location: San Rafael
Posted on: January 9, 2022

Job Description:

Clinical Laboratory & Biospecimen Management SUMMARY : Clinical Laboratory & Biospecimen Management ( CLBM ) is part of BioMarin ' s Development Sciences Operations (DSO) , which coordinat es the exec ution of the various phases of clin ical trials during drug development . CLBM is comprised of three groups : 1.) Study Operations & Sample Request , 2.) Technical Operations and 3.) Vendor & Operational Performance Support. The 3 CLBM groups either directly manage s or supports the management of the central and specialty laboratories and tracks biospecimens (human) from collection to their final d isposition . CLBM a ccomplishes these activities by ensuring all processes and procedures are efficient, effective , well-documented and align with the protocols , informed consents , testing requirements and protocol timelines. The Director in CLBM overs ees the Study Ope rations & Sample Request group and reports to the Senior Director of CLBM. The Director is a leadership position within CLBM and has extensive experience in the following areas: Clinical Trial Operations , Pro cedures and Regulations; Biospecime n Management, Vendor Sourcing & Contract ing , Informed Consent ( ICF) Design & Interpretation , Central and Specialty Lab T esti ng and M anagement ; Strategic Planning; Biospecimen Inventory System Use ; and Shipping and Custom Regulations . A s a s e a s o n e d a nd we l l -res p ected l e a d e r, the D i rector p l a y s a pi v ot a l ro l e i n set t i n g the d i rec t i on of t h e Study Operations & Sample Request group within CLBM and collaborates continuously with CLBM ' s other groups, i.e., Technical Operations and Vendor and Operational Performance Support . The Director assists T echnical Ope rations in utilizing and improving CLBM ' s systems and technologies . Likewise, this position also works closely with Vendor & Operational Performance Suppor t group to develop all BioMarin b ios pecimen governing documentation . H /She i s also a k e y co n t r i b u t or to cros s - f u n c t i o n a l activities needed to successfull y execute on clinical trials , o p e ra t i o n al i m pro v e m e n t , a n d c h a n g e i nit i a t i v es that impact biosp ec imen and central and specialty laboratory management . CLBM ' s Study Operations & Sample Request group is responsible for working with Clinical Operations /GMAF Study Management , Development Sciences Business Operations, Clinical Data Management, Legal, GCP Compliance, Devel opment Science Quality, and research teams to ensure a smooth process flow for all biospecimen-related activities. RESP ON SIBILITIES :

• Be a strategic, scientific and service pricing SME duri ng vendor sourcing and selection process for new or existing ce ntral and specialty lab s or other vendor types as needed as considered for BioMarin clinical trial s .
  • A c t as a primary stakeholder with others in CLBM, as needed , in t he central and specialty laboratories sourci ng p rocess that includes identification, evaluation , and selection o f new vendors tha t would be the best fit for each study 's needs and documenting recommendations and decisions.
    • Including participating in " virtual " and in -person operational visits , when sched uled.
    • D efine and clarify cross-fun ctional expectations during sourcing and management of c entral and specialty labs so that sta ndardized practices and procedures can be implemented .
    • Leverage input for more accurate price alignment between central and specialty lab cost proposal s with actual biospecimen and testing needs.
    • Participate on conference calls with biobank vendor or a ny vendor a s a SME or a point of escalation , as needed.
    • A dvise CLBM and cr oss- functional staff on central and speci alty lab vendor management using " BioMarin ' s best practices " when new protocols are starting especially as related to contracting and subcontracting scenarios .
    • Be a point of guidance and/or escalat ion for existing central and specialty lab oratorie s to address any oper a tion al questions/issues that may aris e and n eed to be resolve d or triage d to the appropriate individual or cross-functional group.
      • Review various documents and plans to ensure BioMarin's and vendor 's expectations are aligned and standardized, so vendor per form ance and quality metrics are developed , agreed to and implemented.
      • Join as needed in vendor conference calls on relevant topics .
      • Review, access and escalat e, wh en necessary, unresolved operational issue s t o JOC and/or EOC Cha ir and other c ross-functional teams, as needed.
      • B e ava ilable as a SME and/or coach for v endor invoice re view and payment from the i nternal accounting system and provide input to CLO /GMAF study management for their final approval of pending invoices.
      • Provide guidance and act as the interface to CLBM and B AS/TS staff for assays in e arly development to be added to protocol testing or to seamlessly transi tion testi ng of clinical biospecimens BAS / TS to a specialty lab
      • Participate in Study Execution Team ( SET ) and other cross functional meetings as a n a dhoc member throughout the life cycle of a clin ical trial to provid e input , if needed :
        • O n escalated vendor and biospecimen handling issues .
        • O n escalated decisions regarding biospecimen collection, processing, storage, and shipping ; kit design, data deliverable s and contract modifications .
          • Be well-versed in I nter national Air Transport Association (IATA) and Customs Regulations for biospecimen and ancillary s upply shipments.
          • Participate in d efin ing and pe riod ically r eview ing study - related data i n the clinical biospecimen inventory tracking system .
            • Review the standardized inv entory data template and main tain all planned biospecimen-relevant information , i.e., relevant details for each biospecimen type colle cted.
            • Acts as the Bu siness Owner of CLBM sys tems - provides busin ess requirements for s ystem operational design and e nhancements.
            • Perform steward duties for Analysis Request (AR) , if neede d.
              • Be the point of con tact with B AS/TS colleagues that have quest ions about availability and su itability for future research use of residual clinical biospecimens.
              • Has a strong scientific background in a relevant field to appreciate biomarker discovery res earch topics that are relevant to AR review for future research.
              • Participate in inquiries relat ed to the appropriateness or integ rity of biospecimens, work with C L BM S teward s on disposal requests as appropriate .
              • Participate in C L BM process improvement pro jects , as needed .
              • Be the project manager for the Biospecimen Auth orization Committee (BAC) who oversees the ethical use of clinical biospe cimens .
              • Recommend st rategic goals to CLBM and Development Sciences Operations senior management.
              • Be the chair of t he Biospecimen Core Working Group to obt ain cross-function al input from BAS/TS, Legal, GCP, and RDQ on biospecimen-related issues or assessment of BioMarin ' s approach to new regulations .
                • For example, ICF word ing for biospecimen-related sections to ensure standard ization across all BioMarin protocol s .
                • Be an effective staff career developer and coach that aligns with CLBM ' s strategic plans . Experience: Required Skills: The Director of Study Operations and Sample R equest is expected to demonstrate mastery level ( extensive, expert-level of understanding an d proven performance ) in the f ollowing Core Co mpetencies: Leadership, C ommunication, Problem Solving and Decision Making, Influencing and P ersuasion, Planning, Prio ritization, and Organization, Teamwork and Relationship Building, Proactivity and Initiative and People Management includi ng:
                  • A ctively con tributing to cross-functional team definition of goals, roles and tasks .
                  • P roactively expanding one's network and work relationships outside the depart ment .
                  • A bility to create inclusive and collaborative cross-fu nctional team and meeting envi ronments .
                  • A bilit y to recognize and articulate and prioritize key issue s that arise based on understanding of objectives so that issue s are resolved .
                  • A bility to analyz e and evaluate problems and seek- out and recommend possible solutions before escalation .
                  • L everaging d ata e ffectively to communicate points of view and influence outcomes .
                  • E ffectively lead meetings, track action items . Desired Skills: The Director s hould demo nstrate a mastery level of knowledge (extensive, expert- level of understanding and pro ven performance ) across all primary technical competencies , including Biospecimen Management Processes & Logistics , Vendor Management & Lab Operations , Contrac ting, Sourcing, ICF R eview, Clinical Trial Operations, Shipping an d Custom Regulations, Budget Ge neration and Rev iew , Project Management, and Lab Operations, Good Practices and Compliance, and Drug Development , Study Design & Study Execution, and IT, Biospecimen Systems & Data Analysis . Specifically, t his includes :
                    • U nd erstand ing of end- to-end biospe cimen management lifecycle , i.e., biospecimen collection, processing, storage , shipping and destruction .
                    • U nderstanding of informed consent and its impact on biospecimen management .
                    • U nderstanding of managing central and specia lty lab 's handling of biospecim ens , biospecimen collection kits, protocol deliverables, timelines and test results as related to the 3 phases of a clinical trial, i.e., Protocol Concept & Study Start-up, Enrollment & Maintenance, and Close-Out Phase s .
                    • U nde rstanding of GxP principals and how they impact biospecimen operational and vendor management activities , and what appropriate steps and path need to be taken to escalate .
                    • U nderstanding of study protocol obje ctives and methodology .
                    • U nderstanding of financi al documents for review, standa rdization and coa ching . Education:
                      • BA/BS in life sciences or related degree. Advanced degree preferred. Experience in lieu of education accepted.
                      • 12 years of relevant experience working in the pharmaceutical industry (inclu ding CROs, clinical sites, labs and biorep ositor ies) .
                      • 6 years of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations .
                      • At least 5 years of pe ople management a nd coaching experience. EQUIP MENT:
                        • Computer work utilizing c ommon business so ftware programs.
                        • Experienced in the following software: M icrosoft Office Products including Visio, Project, Excel, Teams, and SharePoint ; Labmatrix to track bio bank biospecimens and processes ; and Monday.com for project management .
                        • The emp loyee must occasi onally lift and/or move up to 25 pounds. Specific vision abilit ies by this job include close vision, depth perception and ability to adjust focus. Contacts: The Director will work closely with other member s and grou ps within C L BM , i.e., Technology Opera tions and Process Improvement and Documentation Management , and cross-functional groups such as:
                          • Internal : I nformation Management (IM ) , Development Sciences Operations ( DSO) , Legal, Compliance, Clinical Da ta Management (CDM) , Translatio nal Sciences (TS) , Biomarker Discovery, Clinical Sciences (CLS), Global Strategic Sourcing (GSS), Regulatory Affairs, Global Medical Affairs ( G MAF) , Finance, Accounts Payable, and Human Resources .
                          • External : Central and Specia lty Laboratories , and bioreposi tory ' s project ma nagers , business development staff, senior management , counterparts or appropriate staff members at partner companie s . T h e Di rector m a y m a n a g e up t o 6 d i rect re p orts a n d m a y m a n a g e m u l t i p l e h i erar c h i c al l e v e l s of re p ort s . T h i s ro l e i s resp ons i b l e f or develo p i ng a n d m e n tor i n g a high p e r f o r m i ng Study Ope rations & Sample Request t e a m within CLBM .

Keywords: BIOMARIN, San Rafael , Director, Clinical Laboratory & Biospecimen Management, Executive , San Rafael, California