Nonclinical Study Manager II, Pharmacological SciencesLocation San Rafael, California Apply
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.
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 issues.
- 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 collaborators.
- 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 study teams.
- 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 inspections.
- 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 problems.
- Travel: Up to 25% local, domestic and possibly international travel is required.
- Other duties: As assigned.
- 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 tasks simultaneously.
- Ability to foster and maintain professional relationships with internal and external collaborators in order to complete the given tasks.
- Proficient in Zoom and Microsoft Suite [including Word, Excel, and PowerPoint].
- Experienced in SharePoint for document management.
- Strong understanding of GLP regulations
- Experience conducting or overseeing experiments in compliance withGLP regulations
- Experience in a nonclinical pharmacology/toxicology laboratory.
- Strong understanding of drug development, nonclinical study design, data management systems, study procedures, and documentation practices.
- Experience with preparing nonclinical sections in support of regulatory submissions.
- 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.