Nonclinical Study Manager II, Pharmacological Sciences
Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: November 22, 2021
This job is based in San Rafael, CA and open to flexible work
arrangements BioMarin is the world leader in delivering
therapeutics that provide meaningful advances to patients who live
with serious and life-threatening rare genetic diseases. We target
diseases that lack effective therapies and affect relatively small
numbers of patients, many of whom are children. These conditions
are often inherited, difficult to diagnose, progressively
debilitating and have few, if any, treatment options. BioMarin will
continue to focus on advancing therapies that are the first or best
of their kind. BioMarin's Research & Development group is
responsible for everything from research and discovery to
post-market clinical development. Research & Development involves
all bench and clinical research and the associated groups that
support those endeavors. Our teams work on developing
first-in-class and best-in-class therapeutics that provide
meaningful advances to patients who live with rare diseases. Come
join our team and make a meaningful impact on patients' lives.
POSITION SUMMARY:The nonclinical study manager/study monitor's
primary responsibility is to centrally manage all activities
required for the effective design, execution, and completion of
nonclinical pharmacology, toxicology and PK/ADME studies conducted
with contract research organizations (CROs) or with academic
collaborators for specific BioMarin drug development programs.
These activities include, but are not limited to: study planning
and contracting, developing the protocol to maintain the overall
study objectives, coordinating test material transfer and principle
investigator activities, ensuring adherence to the protocol,
monitoring via site visit/email/telephone, managing and reviewing
study documents/data, finalizing the study report and archiving the
study files. This individual is expected to take responsibility for
the studies and understand the overall objectives of both the study
and program. For Good Laboratory Practice (GLP)-regulated studies,
the study manager will ensure compliance with the appropriate and
current GLP regulations. This individual will directly support
regulatory submissions (IND/CTA, NDA/BLA, IB, etc) by providing
study reports, preparing sections of the written and tabular study
summaries, and reviewing nonclinical regulatory documents. The
study manager, being the primary point of contact between BioMarin
and the CRO/collaborator, will work closely with lead scientists,
project managers, GLP compliance, and laboratory groups within
BioMarin to plan, develop, and execute nonclinical studies to
support program timelines and objectives. This position requires a
high level of organization and concise communication skills with
multiple internal and external contributors for the successful
execution and completion of CRO/academic studies. The study manager
will help to identify study-related issues, both preventatively and
as they occur, and will work in partnership with respective
functional areas to develop the optimal resolution plan. The study
manager is required to be an active participant in project teams
and lead nonclinical study subteams, as applicable, for programs in
which they are assigned. The individual will also interact with
BioMarin regulatory affairs, corporate and GLP compliance, program
management, research, manufacturing, quality, etc. to provide the
appropriate nonclinical support and expertise.
- Effectively manage all aspects of GLP and non-GLP nonclinical
pharmacology, toxicology and pharmacokinetic studies, with minimal
supervision, and contribute to scientific study design.
- Manage the program nonclinical study team(s) to design and
execute studies and identify key data readouts and risks.
- Manage progress of studies to ensure that study activities are
consistent with the protocol, study objectives, and project
strategy. Responsible for effective and efficient resolution of
protocol discrepancies and revisions.
- Proactively ensure that GLP studies are conducted in compliance
with the current regulatory requirements and with collaboration
between BioMarin and CRO quality assurance units.
- Anticipate, troubleshoot and suggest solutions for
study-related issues that arise. Appropriately escalate
- Edit, with minimal supervision, and manage the team review of
study synopses, protocols, data, reports, and other study documents
to ensure accuracy, consistency, and completeness and to enable the
timely execution and completion of nonclinical studies.
- Ensure the timely and accurate transfer of study samples, data,
and study documents between internal and external
- Develop, track, and ensure adherence to study timelines.
- Prepare and provide regular, relevant, and succinct study
updates with verbal or slide presentations to lead scientists and
- Develop and maintain relationships with study directors,
principal investigators and other external collaborators.
- Maintain a solid understanding of GLP regulations and documents
governing inspection readiness. Provide support, and participate if
needed, during internal functional group audits and regulatory
- Prepare sections, with minimal supervision, of the regulatory
written and tabular summaries and assist in the review of various
regulatory documents and summaries.
- Work with outsourced vendors, including issue resolution, and
contribute to vendor expectations.
- Mentor junior team members, as needed.
- Propose and assist in sustainable solutions to business
- Travel: Up to 25% local, domestic and possibly international
travel is required.
- Other duties: As assigned. EXPERIENCE:Required Skills:
- Minimum: Bachelor's (BS/BA) in Biological Sciences or closely
related field of study.
- 5+ years of experience in a pharmaceutical, biotechnology, or
contract research organization or equivalent.
- General understanding of GLP regulations
- Excellent verbal and written communication skills.
- Excellent organizational, operational and computer skills
including attention to detail/documentation, the ability to learn
quickly, and the ability to manage multiple projects and multiple
- Ability to foster and maintain professional relationships with
internal and external collaborators in order to complete the given
- Proficient in Zoom and Microsoft Suite [including Word, Excel,
- Experienced in SharePoint for document management. Desired
- Strong understanding of GLP regulations
- Experience conducting or overseeing experiments in compliance
with GLP regulations
- Experience in a nonclinical pharmacology/toxicology
- Strong understanding of drug development, nonclinical study
design, data management systems, study procedures, and
- Experience with preparing nonclinical sections in support of
- Proficient in SharePoint and Veeva for document management
- Proficient in Excel data tables, pivot tables/figures, and
macros.PLEASE NOTE: Absent a Medical or Religious reason that
prohibits vaccinations, all our incoming employees must be
vaccinated for COVID-19. 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.
Keywords: BioMarin Pharmaceutical Inc., San Rafael , Nonclinical Study Manager II, Pharmacological Sciences, Executive , San Rafael, California
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