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Consultant study manager biotechnology

Life Sciences Group, Inc.

This is a Full-time position in Sausalito, CA posted October 31, 2019.

Study Manager, Biotechnology The study manager’s primary responsibility is to centrally manage all activities required for the effective execution and completion of nonclinical pharmacology, toxicology, and PK/ADME studies conducted with contract research organizations (CROs) or with academic collaborators for specific drug development programs.

These activities include, but are not limited to: study planning and contracting, protocol development to maintain the overall study objective, material transfer coordination, coordination of principle investigator activities, ensuring adherence to protocol, monitoring via site visit/email/telephone, study document/data management and review, and study finalization/reporting.

This individual is expected to independently and proactively take responsibility for the studies and understanding 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, written, and tabular study summaries and reviewing nonclinical regulatory documents.

The study manager, being the primary point of contact between the client and the CRO/collaborator, will work closely with lead scientists, project managers, compliance, and laboratory groups within the client to plan, develop, and execute nonclinical studies to support program timelines.

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 collaborator 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 sub-teams for programs in which they are assigned, and will interact with regulatory affairs, corporate and GLP compliance, program management, research, manufacturing, quality, etc.

to provide the appropriate nonclinical support and expertise.

/ Expectations of Anticipate issues and suggest optimal solutions.

Appropriately escalate issues with significant impact and provide solid rationale for decision.

Independently and effectively manage multiple programs of high complexity.

Independently produce succinct, standard project plans for programs based on drug class/type and current stage and understands rationale for all conducted studies.

Independently manage all aspects of GLP and non-GLP nonclinical pharmacology, toxicology and pharmacokinetic studies and contribute to the scientific study design.

Lead/manage progress of studies to ensure that study activities are consistent with the protocol and with the project strategy.

Review study data, as needed.

Responsible for effective and efficient resolution of protocol revisions and discrepancies.

Independently edit and lead the review of study synopses, protocols, data, reports, and other study documents for consistency, completeness, accuracy, and timeliness.

Provide regular, relevant, and succinct study updates and leverage scientific knowledge and operational skills to positively impact study outcomes.

Experienced and proactive in leading multiple cross-functional teams to design and execute studies and identify key data readouts and risks across all drug development phases.

Responsible for timely and accurate transfer of study samples, data, and documents between internal and external collaborators, and foster relationships with study directors, principal investigators, and other external collaborators.

Solid understanding of GLP regulations and documents governing inspection readiness.

Participate in internal inspections, functional group audits and external technical evaluations of CRO facilities.

Independently and proactively ensure that GLP studies are conducted in compliance with current regulatory requirements and with collaboration between Sponsor and CRO quality assurance units.

Independently prepare ARC-compliant study synopses and address the majority of ARC-related comments, requiring minimal Lead Scientist oversight.

Work with outsourced vendors, including issue resolution, and contribute to or author vendor expectations.

Proficient in Microsoft Suite, including Word, Excel, and MS Project (e.g.

Excel data tables, pivot tables, macros, relational lookups).

At least 10% of FTE devoted to developing and implementing successful and sustainable solutions to business needs.

Independently prepare regulatory written and tabular summaries and assist in the review of various regulatory documents and summaries.

Mandatory 8 years of experience in a pharmaceutical, biotechnology or contract research organization or equivalent.

Prior experience conducting or overseeing experiments under GLPs Experience in IND phase of trials.

Excellent verbal and written communication skills.

Excellent organizational skills and 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.

Preferred Prior experience in a nonclinical pharmacology/toxicology laboratory.

In-depth knowledge of the Good Laboratory Practices (GLPs) as they relate to regulatory submissions.

Experience with preparing nonclinical sections in support of regulatory submissions.

Windows network environment, MS Word, MS Excel, MS PowerPoint, MS Project Additional Notes Initial engagement 12 months Onsite in the San Francisco Bay area Some weekly remote (2-3days/week) 25% global travel