Associate Director/Director, Translational Medicine Operations

Our client, a fast-growing, innovative biotechnology company developing the next generation of personalized cancer immunotherapies, is urgently recruiting for an Associate Director/Director of Translational Medicine Operations for their Cambridge, MA location. As the Associate Director/Director, you will be responsible for all activities related to the lifecycle management of clinical biospecimens and biorepository operations.

Job Responsibilities:

• In collaboration with other functional SMEs, lead the development and execution of biospecimen collection requirements for clinical studies, sponsored-research agreements, and/or academic collaborations.
• Collaborate with Clinical Development and Clinical Operations to ensure that specimen requirements are appropriately reflected in core clinical documents, ie., clinical study protocols, informed consent forms, Case Report Forms (CRFs), study procedure manuals, training materials, etc. Direct/lead the development of TM Ops specific materials as required to ensure the accurate and consistent collection of specimens and specimen data for assigned studies/programs.
• Direct/lead the identification, evaluation, selection and onboarding of TM Ops vendors in support of clinical study execution. Review/negotiate vendor agreements and budgets. Manage vendor deliverables and performance.
• Lead the execution of non-treatment (observational, specimen collection only) clinical studies.
• Accountable for all clinical specimen collection, tracking, handling, management, reconciliation and disposition for assigned studies/programs. Provide accurate and timely updates to the study team, functional leadership, and other key stakeholders.
• Lead the development of TM Ops tools, metrics and reports to identify process inconsistencies, errors, delays, or risks to specimen collection or analysis.
• Identify risks and lead TM Ops process improvements to ensure success in study execution.
• Contribute to clinical study budget development. Manage TM Ops budget for assigned studies/programs.
• Provide input into resource allocation and assignment. Draft staffing plans for assigned clinical programs.
• Provide support, mentorship, and direction to direct reports, including performance management. Develop training plans.
• Develop departmental policies and SOPs for TM Ops.
• Support strategic planning for TM Ops.

Skills and Requirements:

• Bachelor's degree (or equivalent), preferably in scientific discipline or a health-related field.
• Prior experience leading teams, managing employees, and developing department processes, templates and Standard Operating Procedures (SOPs).
• Background in basic research, with knowledge of oncology or immunology principles preferred.
• Familiarity with common biological assays and methods (sequencing, IHC, PCR, etc.)
• 10 years relevant industry experience, with at least 7 years managing clinical specimen operations for global oncology or immunotherapy studies. Prior experience managing direct reports, coaching and developing junior team members, and leading teams.
• Knowledge of global biobanking issues and regulations pertaining to biospecimen transport. Knowledge of ISBER Best Practices. Thorough knowledge of ICH/GCP guidelines and FDA regulations.
• Able to work effectively and collaboratively in a fast-paced, small start-up company environment.
• Must be self-motivated, highly organized, detail-oriented and able to multi-task while delivering high quality work.
• Excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
• Strategic agility, strong critical and logical thinking with ability to analyze problems.
• Strong ability to prioritize and work in an evolving environment.
• Excellent presentation and written/verbal communication skills.
• Excellent computer proficiency (MS Word, Excel, PowerPoint).

If you are having difficulty in applying or if you have any questions, please contact Natasha Patel at (+1) 617-778-7319 or n.patel@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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