Director, Clinical Laboratory & Biospecimen Management
Location: San Rafael
Posted on: January 9, 2022
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
- 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
- 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
- Participate in d efin ing and pe riod ically r eview ing study
- related data i n the clinical biospecimen inventory tracking
- 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
- 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
- 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
- 6 years of relevant technical experience working with
biospecimen management, lab management, biobanking, or similar
- At least 5 years of pe ople management a nd coaching
experience. EQUIP MENT:
- Computer work utilizing c ommon business so ftware
- 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
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