Manager, Lab And Sample Management

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that's passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview

As an integral member of the Clinical Operations team, the Project Manager, Lab and Sample Management will be responsible for sample management and laboratory processes within diagnostic laboratories, CROs and external vendors involved in clinical studies. This position will report into the Director, Lab & Sample Management Operations.

Responsibilities and Duties

• Day-to-day communication with external diagnostic programs, partner laboratories and CROs to ensure on-time delivery of samples and reporting of data across multiple projects.

• Oversee clinical samples lifecycle management, including central laboratory third party laboratory, and long-term storage inventories to ensure sample holdings meet business and regulatory requirements.

• Sample management of ongoing clinical studies.

• Guiding internal rhythm data exchange, based on samples processed at diagnostic laboratories.

• Support the creation and revision of lab related documents, both internal and site facing.

• Proactive identification, mitigation, and resolution of lab and sample related issues.

• Project management of ongoing clinical laboratory initiatives.

• Support QA activities in auditing and troubleshooting external vendors.

• Participation in quality and operational improvements within the company focused on external laboratory vendors.

• Evaluate capabilities and qualifications of potential and contracted laboratory vendors based on portfolio needs.

• Lab vendor Purchase Order (PO), Statement of Word (SOW), and invoice management.

Qualifications and Skills

• BS or BA in a Life Science or related field.

• Minimum of 5 years' experience with CLIA/CAP accredited laboratories or CROs; MLS/MT (ASCP) certification preferred.

• Regulatory knowledge, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

• Exceptional organizational skills and ability to deal with competing priorities, strong reasoning, and problem-solving ability.

• Ability to assemble a plan and execute on the details.

• Proficient with MS Office Suite (Excel, Word, and PowerPoint).

• Ability to communicate effectively with internal and external stakeholders.

• Project Management experience preferable

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

More about Rhythm

Rhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of hyperphagia and severe obesity due to rare melanocortin-4 receptor (MC4R) pathway diseases. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm's mission is to improve the understanding of these diseases and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company's clinical development program is currently focused on several rare MC4R pathway diseases. For healthcare professionals, visit www.RareObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.