BioSample Manager/Sr. Manager (12 month Contract)
At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
This role can be fully remote
In this role, the BioSample Manager/Sr. Manager partners with Development Science and Clinical Operations teams to plan and coordinate all operational activities required to collect, deliver, and assay PK and PD biomarker samples within DICE clinical studies. The BioSample Manager/Sr. Manager is responsible for the development of PK/PD biomarker sample management strategies and contributes to a positive and collaborative team environment. The position reports to the Director of Biomarker/Translational Pharmacology in DevSci and is based in SSF with the potential for flexible work arrangements. The job title will be based on experiences and qualifications.
- Develop and author Sample Management Plans. Work with PK and PD Biomarker leads and ClinOps teams to provide oversight related to biosample management and establish workflows and timelines to ensure consistency in biosample collection, shipments, inventory, processing, testing, and storage across all DICE clinical studies. Manage sample logistics from collection, assay, leading to data review. Provide sample management updates to teams as needed.
- Partner with Development colleagues to outsource PK and PD biomarker testing to specialty lab vendors: identify and select vendors, develop SOWs, review budgets, track contract completion within expected timelines, and provide vendor management/ cost management support throughout contract lifecycles. Responsible for specialty lab vendor budget management and sample storage-related costs (including long-term storage strategies).
- Review lab SOW to ensure kits/supplies are correct for sample collections in all different matrices. Ensure sample processing instructions are correct, storage conditions and shipping frequencies are accurate, and meet the data delivery timelines. Oversee lab kit supplies in collaboration with CRO/CRA/Central labs.
- Serve as a key reviewer for Central lab SOW and budget, facilitate Central Lab setup including sample collection and processing instructions, kit contents, shipping conditions, and logistics. Work with Central Labs to streamline sample collection and shipment to specialty labs. Serve as a Sponsor’s point of contact for sample management-related query resolutions, negotiating with couriers and external vendors. Attend regular lab vendor calls.
- Must have ability to identify and mitigate risks to ensure accuracy in sample collection, delivery, and analysis. Track and manage all sample-related activities for PK and PD assessments routinely and provide regular updates. Provide technical expertise to address clinical site and Central Lab questions related to sample handling. Develop productive working relationships with vendors, business partners, and other stakeholders.
- Review ICF, Clinical Protocols, and Study Reference or Lab Manuals (for any sample collection-related sections, and the sample storage/retention details in ICF) to ensure accuracy and consistency with the sample management needs. Provide input on IRB/HA/EC questions related to biosample collection, testing and storage in alignment with study protocols. Ensure proper long-term storage of clinical samples and sample retention are in compliance with regulatory requirements.
Preferred Experience and Education:
- BS in life sciences (MS, or PMP certification highly desired) with minimum 5 years of experience in clinical trials or clinical development in a biotech/pharma industry and possess a strong knowledge of drug development.
- Has a strong understanding of scientific needs as well as clinical processes to bridge the needs between Development Sciences and Clinical Operations functions. Must have research and clinical background.
- Experience in working in clinical studies in cross-functional team environment. Experience in processing and analysis of biological samples in a biological or clinical laboratory.
- Working experience in drug development industry and familiar with GCP/GLP regulatory requirements.
- Proven ability to manage multiple projects with competiting priorities. Detail oriented and have strong organization skills. Ability to identify risks and resolving complex problems.
- Proven ability to work independently and build and maintain positive working relationships with vendors.
- Excellent verbal and written communication skills. Self-motivated and able to work independently as well as collaboratively.
- Thrives in a collaborative team setting and is driven by a desire to be innovative in a high-energy, small company environment.
- Proficient in Microsoft Office Applications including Excel, Word, and PowerPoint.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.