Director/Senior Director, Clinical Affairs – HYBRID

Who We Are

RefleXion transforms radiopharmaceuticals from diagnosing cancer to actively controlling delivery of external-beam radiotherapy by leveraging individual tumor biology. Designated an FDA Breakthrough Device, RefleXion’s SCINTIX™ biology-guided radiotherapy automates targeting and motion management to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. In strategic collaborations with radiopharmaceutical companies, RefleXion is co-developing and co-commercializing disease-specific radiotracers for difficult to treat late-stage cancers.

Find out more about RefleXion and SCINTIX therapy at reflexion.com.

About This Role

The Director/Sr. Director, Clinical Affairs will contribute as a leader to the development, implementation and conduct of RefleXion’s clinical programs.  The Director is accountable for strategizing, execution and leading 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.

What You Will Be Doing

• Provide leadership to the Clinical Affairs team - supervise and direct the activities of the Clinical Affairs staff.
• Lead and oversee the overall management of multiple clinical trials including protocol writing, interpretation of clinical data, literature reviews and 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.
• Contributes clinical affairs expertise in all operational activities pertaining to the execution of clinical trials, cross-functional team meetings and initiatives; Represent the Clinical Affairs function line on multidisciplinary project teams.
• Assist Regulatory Affairs to ensure the timely preparation of quality clinical study documents to be submitted to the FDA and other health authorities in support of regulatory applications.
• Discover potential risks and implement mitigations to avoid delays in clinical trial execution.
• 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.
• Other duties as assigned.

Where You Will Do This Job  

• Hybrid - This position will allow the successful candidate to work on a Hybrid work location schedule. They must be based in the greater SF Bay Area and must be able to commute to the RefleXion office in Hayward 1-4 days a week, depending on the role.

What We Need

•  BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
• Experience 8+ years or 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
• Travel Requirements: Up to 25%

What You Will Love About Working with Us!

•  The opportunity to work with a passionate, driven team in a pre-IPO start-up environment.
• Flexible work location and schedule – hybrid work environment for many positions
• Competitive compensation and Pre–IPO stock option packages
• Medical (both HMO and PPO options), Dental and Vision
• Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
• Pre-tax Commuter Benefits
• Employee Assistance Program (EAP)
• 401(k)
• 3 Weeks/Year PTO Accrual rate to start and 12 Paid Company Holidays
• Employer paid Life Insurance, short-term and long-term disability.
• RefleXion Benefit Hub –Company exclusive discounts and deals on a variety of sites and items
• Weekly catered on-site lunches as well as kitchens filled with a variety of healthy and delicious food and drinks – including an espresso machine and panini stations!
• Employee Events – Variety of Workshops, Lunch ‘n Learns, Financial Wellness education, Regular “Coffee Chats” with Executive Leadership, Scavenger Hunts, Company Milestone celebrations and more!
• Electric car charging stations on site

The annual pay range for this role is $210,000 – $250,000. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

 Values and Diversity

RefleXion is an equal opportunity employer. All aspects of employment including the decision to hire will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, disability/medical​​​ condition, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.