Kapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. We are looking for a Clinical Team Lead to help us continue to grow our business and deliver new, life-changing therapies for the cancer patients who need them. This is a newly created position! As a Clinical Team Lead, you will: Plan, track and prioritize clinical trial deliverables for interdisciplinary clinical research studies. Act as a primary liaison between the company and the customer, ensuring satisfaction levels are met and statuses of clinical deliverables are communicated effectively. Partner with line managers and project managers to ensure monitoring responsibilities for projects are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements. Proactively identify and resolve complex issues with both internal and external stakeholders. Develop clinical monitoring plans and ensure timely update of plans, if required. Drive risk identification and risk monitoring strategy, ensuring that appropriate risk monitoring tactics are written into the CMP, and be accountable for the clinical team’s understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP, and risk plans. Routinely review clinical systems, dashboards, and documentation (e.g., Site Assessment Reports) to oversee site and study team conduct and identify any risks to delivery or quality.
Knowledge, skills and abilities:
Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology industries.
Knowledge of basic financial and project management principles.
Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Solid grasp of risk-based monitoring, issue escalation, and CAPAs.
Therapeutic area expertise (e.g., oncology, cell & gene therapy, rare disease)
Requirements:
Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
Minimum of 5 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses, including at least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies.
Previous clinical management and leadership experience.
The anticipated salary range for this role is up to $145k/yearly with bonus potential. Actual compensation will depend on experience, location, and other factors.
Candidates must be authorized to work in the United States without current or future sponsorship.
We are an equal opportunity employer and are committed to creating an inclusive environment for all employees. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.
