Title:

Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs Pay:

Starting at $256,000

FT or PT:

Full-Time, Onsite (no flexibility)

Location:

Orange County, CA Kelly® Science & Clinical is seeking a Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs for a direct-hire executive leadership role at our client, an innovative, patient-focused biotechnology company. If you are passionate about advancing cancer therapies and leading multidisciplinary teams to deliver impactful results, trust The Experts at Hiring Experts to help elevate your career. In this high-impact position, you will be responsible for strategic leadership and oversight of Regulatory Affairs, Clinical Operations, and Medical Affairs functions. You will develop and execute global regulatory strategies, oversee clinical trial operations, and provide medical leadership that supports clinical development, regulatory submissions, and commercialization across multiple programs. Your role ensures cross-functional alignment with key internal and external stakeholders, compliance with global regulatory requirements, and continuous innovation in a fast-paced environment.

Key Responsibilities:

Develop and implement global regulatory strategies for product development, clinical studies, manufacturing changes, and commercialization. Lead preparation and maintenance of regulatory submissions (INDs, BLAs, amendments, supplements, annual reports). Serve as the primary liaison with regulatory agencies and provide guidance to executive leadership. Provide strategic oversight of clinical trial planning, execution, oversight of CROs/vendors, and performance metrics. Ensure operational excellence and compliance with

GCP, ICH

guidelines, protocols, and regulations. Develop clinical operational strategies, support site selection, and drive study enrollment. Lead Medical Affairs functions by building strategic partnerships with Key Opinion Leaders (KOLs), guiding scientific communications, and supporting evidence generation, medical education, and post-marketing activities. Collaborate cross-functionally across Research, Development, Quality, Commercial, and Executive Leadership teams. Manage, coach, and develop functional teams, oversee departmental budgets, and foster a culture of compliance, innovation, and results.

Requirements:

Advanced degree (MS, PharmD, PhD, MD, or equivalent); medical degree preferred but not required. Minimum 15 years of progressive leadership experience in biotechnology, pharmaceuticals, or related fields. Minimum 10 years of experience in Regulatory Affairs leadership. Significant experience overseeing Clinical Operations, clinical trial execution, and Medical Affairs. Demonstrated success in regulatory submissions, agency interactions, and supporting products through commercialization. Expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and global regulatory requirements. Proven ability to lead cross-functional teams, drive organizational growth, and operate in a fast-paced, highly regulated environment As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Why Kelly® Science & Clinical?\nKelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly may use AI-powered tools during the recruitment and hiring process. 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