Senior Clinical Biosampling Operations Specialist

Senior Clinical Biosampling Operations Specialist

PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient’s individual tumor and engineering T cells to kill that specific tumor.

If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.  We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!

We are in the San Francisco bay area, the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.

We are currently recruiting for Senior Clinical Biosampling Operations Specialist. This position will report to the CP, Head of Clinical Development and will be based in South San Francisco.  PACT is seeking a Senior Clinical Biosampling Operations Specialist to develop, drive and manage the biosampling activities required for manufacturing and monitoring of PACT’s therapeutic product.

Responsibilities:

• Implement the strategy across clinical stage programs while working collaboratively with a large cross functional team
• Liaise with investigative site staff, external assay laboratories, collaboration partners and CROs
• Lead and be involved in site evaluations, training and on-going assessment of clinical trial centers
• Establish and monitor program(s) goals, milestones and deliverables to ensure goal achievement via a close interaction and collaboration with all functional lines involved in clinical development and manufacturing
• Have oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables
• Oversee and ensure continuous improvement review of department infrastructure through the development of SOPs, guidelines and the use of technology
• Facilitate effective internal and external relationships, and achievement of clinical project goals and objectives
• Be a mentor or manage a growing team and contributing to the commercialization strategy

Qualifications:

• BA/BS/BSN in related life sciences field with prior experience managing biosampling/biomarkers for early stage oncology trials. Advanced degree, and project management certification is desirable
• 8+ years of progressive biosampling/biomarker experience in pharmaceutical/drug development, with a preference for cellular/gene therapy experience. Knowledge of apheresis and good tissue practices a plus
• Proven ability to influence effectively and confidently within a highly matrixed environment
• Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors
• Expertise in the areas of drug development and assay development
• Strong analytical, problem-solving and critical thinking skills
• Demonstrated ability to earn the trust of stakeholders, team members and management
• Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention
• Willingness and capability to work effectively in a smaller pharma company (i.e. willing to roll-up your sleeves as necessary to help get the job done)
• Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
• Ability to operate and lead projects in an exceptionally dynamic and cooperative environment
• Willingness to travel domestically
• Prior experience working in cellular therapy, personalized gene therapy, or stem cell transplant programs preferred
• Prior experience in a hands-on early development role building out a group within a small organization a plus

PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.