Biological Sample Manager
Forty Seven Inc. is a public, clinical-stage immune-oncology company that is developing therapies targeting cancer immune evasion pathways to help patients defeat their cancer. Forty Seven has several therapeutic compounds in development including its lead program 5F9, is a monoclonal antibody against the CD47 receptor, a “don’t eat me” signal that cancer cells commandeer to avoid being ingested by macrophages.
The primary function of this role is to manage all biological samples collected in clinical trials, including vendor management. This position will work closely with teams in Clinical, Translational, Clinical Pharmacology, Biometrics, Data Management, and Clinical Operations as necessary. This position will also provide operational expertise and solutions in support of our clinical program. This position will report into the Vice President of Clinical Development. The role/title of the position will be commensurate on level of experience.
- Develop biological sample management requirements from clinical protocols in collaboration with the clinical study team
- Develop and communicate schedules for sample collection, testing, data reporting, and sample disposition
- Ensure and/or procure appropriate biological sample storage environments for anti drug antibodies, pharmacodynamic and pharmacokinetic samples.
- Develop specific guidelines and procedures for sample collection kit creation, sample collection and handling, transport, storage, sample aliquoting, testing, test result reporting, data aggregation, and sample destruction.
- Communicate to the study team, any relevant issues that will affect compliance and timely completion of the clinical study.
- Manage vendors to ensure that samples are managed, stored (includes long-term inventory of samples), and disposed of consistent with the clinical protocol, with the patient informed consent, and with regulatory and biohazard guidelines, and with international transport guidelines, if applicable.
- Responsible for the day to day management of assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and oversee adherence to scope of work and service agreement.
- Responsible for review of vendor invoices against contract and work completed; identify and transparently communicate variances.
- May author, review, and revise SOPs and other infrastructure as directed
- Build sample management infrastructure, including processes for data analytics on sample tracking, project oversight and other project management activities.
- Works closely with study team lead to provide study logistics support to ensure study timelines are met.
- Works closely with scientific team to assess feasibility of biological sample acquisition
- Primary point of contact for vendors and some key CRO personnel.
- Develop strong working relationships and maintain effective communication with key internal and external stakeholders.
- May participate in; developing and presenting training materials for clinical sites.
- Bachelor's degree in science or health-related field required
- 2 -5+ years in Pharmaceutical or Biotech company.
- Laboratory experience and or Clinical sample management is preferred.
- Oncology or Immunology required .
- Strong vendor management, particularly in sample management is preferred.
- Ability and knowledge to work with multiple stakeholders (clinical, translational research, clinical pharmacology and clinical operations) is important.
- Thorough and proven knowledge of GCP, GLP, CFR and ICH guidelines; Proven track record for delivering clinical projects within time, budget and quality expectations.
- Exceptional interpersonal skills, team-oriented approach, collaborative, flexible and eager to contribute in a sometimes resource-constrained setting
- Highly-motivated, accountable, and able to perform work independently with minimal supervision and with a sense of urgency.
- Must have excellent verbal, written, interpersonal, organizational and communication skills, and able to work under a fast paced environment.
- Working knowledge of MS Word, Excel and Adobe Acrobat.
- Excellent organizational, time management and project management skills.
- Strong working knowledge of GMP/GCP/ICH regulations and guidelines