The Director, Clinical Affairs will contribute to the development, implementation and conduct of RefleXion’s clinical programs. The Director is accountable for the studies ensuring clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), other applicable regulatory requirements, including overseeing external partners to deliver on-time and on-budget.
Responsible for overall management of multiple clinical trials including providing strategic direction to successfully meet corporate goals and timelines.
Participates in the selection and management of contract research organizations (CROs) and other trial vendors.
Oversight of CRO and vendor budgets and contracts.
Lead Clinical Affairs activities including identification of continuous process and system improvement opportunities, leading ongoing needs assessments and ensuring prioritization of activities.
Organize and attend CRO or other vendor meetings such as project kick-off and investigator meetings, face-to-face meetings, and other meetings as necessary to assure alignment and achievement of study goals.
In partnership within the Clinical Development team and other relevant departments, contribute to definition, development and implementation of clinical operations processes and procedures, in accordance with recognized best practices.
Contributes clinical affairs expertise in all operational activities pertaining to the execution of clinical trials, cross-functional team meetings and initiatives.
Maintain awareness of major advances in radiotherapy/oncology, relevant to RefleXion.
Applies strong analytical and business communication skills.
Travel may be required up to 25% in support of clinical study activities.
Proven track record as a leader in clinical trials in the medtech, biotech, CRO or pharmaceutical industry, with oncology trials preferred.
Typically requires a minimum of 8-10 years of related experience or a minimum of 12 years combined education/training and experience.
Management experience including outsourcing to CROs and line management.
Comprehensive understanding of current best practices in industry and ability to incorporate them into new or existing programs and processes.
Extensive experience leading multiple projects involving complex issues and decision-making.
Demonstrated ability to understand, evaluate and interpret data.
BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience.
Strong Communicator: You will have extensive correspondence that relies on you being conversant in clinical trial terminology and regulatory guidelines.
Organized: You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solver: As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable: You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible: Thorough understanding of clinical trial methodologies and sound analytical support, you quickly establish credibility as a reliable resource.
About RefleXion Medical
RefleXion Medical, founded in 2009, is a privately-held pre-commercial company developing the first biology-guided radiotherapy (BgRT) platform that will drive a new paradigm in cancer care. RefleXion’s BgRT platform is the first to utilize the cancer itself to guide radiation delivery, even in tumors that are moving. The patented technology uses positron emission tomography (PET), the gold standard in cancer staging, one day enabling multiple tumors to continuously signal their location during treatment. PET uses a tracer drug that is accumulated by the tumors and produces emissions illuminating their locations. The RefleXion machine detects the emissions and immediately sends beamlets of radiation directly to the tumor to destroy it.