The Mycobacteriology Development Lead (MDL) will work in partnership with the Sponsor development functions (clinical operations, bioassays, data management, biomarkers), contract research organizations (CROs) and consultants to execute and oversee clinical mycobacteriology biospecimen testing strategies for life-saving tuberculosis therapeutics and vaccines targeting those most in need living in low- and middle-income countries (LMIC).

Main responsibilities:

• Ensure mycobacteriology laboratory compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Laboratory Practices (GCLP), applicable regulatory guidelines, and laboratory procedures.

• Develop the scope of work for the mycobacteriology laboratory on a particular program/study, working with MSL, clinical development leader, bioassay operations manager, and as necessary, the Central Laboratory Operations team.

• Work with Bioassay Operations Manager, Strategic Sourcing, Finance, and Legal to develop and manage budgets and contracts

• Work with cross-functional teams to develop mycobacteriology-related assay timelines, budgets, and milestones.

• Oversee lab capacity building for mycobacteriology support of future clinical trials.

• Collaborate with and oversee the development of validation plans and study documents to ensure trial readiness of each mycobacteriology laboratory.

• Partner with Quality Assurance to ensure the quality oversight of vendors.

• Provide training to the study team, including CRAs, on mycobacteriology-related processes.

• Support oversight of mycobacteriology laboratory activities and services by reviewing lab CRA and Mycobacteriology Consultant visit reports.

• Contribute to data transfer agreements for laboratory data and support the Clinical Data Management team during data cleaning to ensure oversight of sputum samples, data transfer, and reconciliation procedures.

• Continuously standardize, harmonize, and improve processes to operationalize mycobacteriology strategy developed by MSL.

• Provide input on eCRFs pertaining to sputum and biomarker samples.

• Represent Mycobacteriology Team cross functionally by attending clinical trial team meetings, perform eTMF submissions and review, and lead laboratory issue escalations in collaboration with the Central Lab Operations Lead (if applicable).

• Collaborate on regular trial data reviews to identify trends and ensure high-quality results for each study

• Review assay validation and sample analysis reports

• Proactively identify clinical trial implementation challenges and risks relating to mycobacteriology efficacy and propose plans to mitigate those risks

• Propose and collaborate on initiatives to address capacity-building in LMIC

• Be able to travel, including internationally, up to 25%

Required Skills and Qualifications

The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with a strong track record of hands-on experience in a regulated clinical trial environment supporting the outsourcing of mycobacteriological assays with the following mix of personal and professional characteristics:

• BS/MS in science-related field with 5+ years TB-relevant experience (TB program knowledge, services capacity building in LMICs, TB diagnostic/treatment trial experience, etc.)

• Experience in the conduct of clinical trials and with clinical trial processes

• Experience conducting research in low- and middle-income countries preferred

• Experience with vendor operations and oversight

• Excellent organizational and problem-solving skills to multi-task in an extremely fast-paced environment with tight timelines and competing priorities

• Must be able to work both independently and in a matrixed team environment

• Ability to work on several projects simultaneously with minimal supervision

• Demonstrated effective communication skills to internal and external team members.

• Fluency in English is mandatory

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

Please apply with your English CV.

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