Manager, Bioanalytics and Pharmacokinetics

Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions.  We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy.  We are looking for passionate and enthusiastic individuals who share our excitement for this mission.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Bioanalytics and Pharmacokinetics located at our Brisbane office or remote location will be considered.

As a member of Early Clinical Development/Clinical Pharmacology, the manager of bioanalysis and pharmacokinetics is to coordinate and oversee the outsourced bioanalytical activities across all projects in Myovant’s portfolio to ensure a timely bioanalytical support per relevant regulatory guidelines and standards to both clinical and nonclinical programs.  Specific responsibilities include the following:

Essential Duties and Responsibilities

•  Serve as the point of contact between internal cross-function study teams and contract bioanalytical laboratories (CBLs) for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and tracking of data and associated bioanalytical reports.
• Manage CBLs by reviewing scope of work (SOWs) and liaise with Myovant clinical business operations to support contracting and payments, as necessary.
• Work closely with CBLs to oversee the outsourced bioanalytical activities for method development and validation, sample receipt/shipment/handling/analysis/storage, and data delivery and archiving. Communicate/confirm that bioanalytical samples are shipped and tested according to protocol/team timelines, data is returned in the specified format, and all SOW specified deliverables are met.
• Serve as the subject matter expert (SME) of bioanalytical activities, review and approve technical documents for bioanalysis (eg, method validation plans and reports; sample analysis reports), and assess technical capability of CBLs to support protocol implementation and ensure the outsourced bioanalysis studies are conducted with highest quality and scientific integrity in compliance with the protocol, ICH/GCP/GLP, and applicable regulatory requirements.
• Provide forecast to budgeting and timeline for bioanalysis to support design and implementation of clinical studies.
• Author and review bioanalysis-related sections in technical documents supporting regulatory filings (eg, NDA, MAA, IND) or clinical studies (eg, CTA, CSR)

Core Competencies

• Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
• Exercise good judgment and make decision that is appropriate for the organization
• Results-driven, take initiative and ownership to accomplish work
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
• Strive for continuous improvement and embrace innovative ideas in daily work
• Demonstrate coaching skill to develop team
• Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables.
• High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
• Strong analytical background in bioanalytical assay method development, validation, operation, and troubleshooting, specifically for detecting compounds in biological matrices using LC-MS/MS
• Solid understanding of current regulatory requirements, guidelines and standards of bioanalytical assays, particularly ICH, GCP, and GLP
• Experience in clinical study team with involvement of the processing and/or analysis of biological samples
• Working knowledge of pharmacokinetics principles and analysis methodologies (experience in pharmacokinetic data analysis is preferred)
• Ability to manage multiple competing priorities with complex timelines in a positive and collaborative manner
• Excellent communication and negotiation skills
• Excellent interpersonal, organizational and multi-tasking skills with attention to details
• Experience in writing technical reports and documents to support regulatory filings or clinical studies

 REQUIREMENTS (Education and Experience)

• PhD/MS degree in analytical chemistry, biochemistry, or related field
• 5+ years of experience in pharmaceutical industry (or related industry) with bioanalysis, especially using HPLC and LC-MS/MS techniques
• International and domestic travel up to 20%

The well-being and safety of our employees is our top priority.  Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based).  Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered.  If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

If you require any accommodations, please email careers@myovant.com.

Equal Employment Opportunity

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