Our client is an early-stage small molecule company focused on oncology therapeutics. We leverage our expertise in medicinal chemistry and cancer biology to advance drug candidates with the potential to deliver significant clinical benefit to patients suffering from cancer. Located in Newbury Park, California, about an hour north of Los Angeles, we have an exceptionally talented team of experienced researchers and drug developers dedicated to high quality science and innovation while building a dynamic and successful oncology company. We focus on challenging, disease-relevant pathways and translate insights into transformative medicines. We are looking for exceptional people with the same passion for patients and cutting-edge science with the goal of developing important therapies and building a uniquely successful oncology drug development company.
Therapeutics company seeking the first Vice President of Clinical Development to join the company and become a key contributor on the Leadership team. The Vice President of Clinical Development will build the clinical strategy for our lead program and pipeline molecules including the design and execution of phase 1 and label enabling studies. This person will also build the Company’s clinical skills and capabilities necessary to be a world class Oncology drug development company. This is a critical leadership position, and this role will have significant exposure and growth opportunities.
The ideal candidate must be an MD who is experienced in early-stage oncology drug development strategies and execution. Experience in all phases of drug development is a plus and working cross-functionally is critical to success in this role. Experience in a lean small company atmosphere leveraging external resources is desired.
Responsible for the Clinical/Medical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance all regulatory and compliance requirements.
Own the creation and maintenance of the program level Clinical Development Plans.
Own the delivery of the clinical development programs across the Therapeutic’s pipeline.
Be accountable for clinical timeline deliverables and to drive decision making.
Have an in-depth knowledge of Oncology Therapeutics, with a passion to remain current on cutting edge therapies, targets and modalities.
Provide scientific and medical direction at the Leadership Team level
Operate at both the strategic and operational levels.
Interact cross-functionally to communicate clinical strategies and objectives, inform biostatistics and clinical operations, and other relevant stakeholders.
Provide clinical leadership in clinical study and program teams, and lead clinical communication to upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issues
Author and/or review clinical documents required for the conduct of clinical studies, including clinical protocols, informed consent documents, investigator brochures, and safety management plans in compliance with regulations and good clinical practices and other key regulatory documents, including INDs, annual safety reports and briefing packages.
Prepare presentation materials for internal and external meetings, such as clinical team meetings, Scientific and Clinical Advisory Boards, scientific congresses and Board of Director Meetings.
Lead ongoing data review, analysis and interpretation to understand safety and efficacy profile of the investigational drugs.
Collaborate with Clinical Operations group to identify and qualify global study sites and build strong professional relationships with study investigators
Serve as the first medical point of contact with sites: answer site questions about patient eligibility, enrollment, and provide clinical input into patient safety assessment and management.
Review and assist creation of data analysis plans, case report forms (CRFs), study reference manuals, laboratory and biomarker manuals, patient diaries, and drug accountability forms
Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents
Design optimal Clinical Development organization structure and recruit, train, retain clinical Development Team as the organization grows.
Medical Degree is required, medically trained with industry experience of clinical drug development.
Experience in the successful delivery of early phase clinical trials in patient populations. Insights to the conduct of innovative trial design is a key advantage.
In-depth knowledge and application of Pharmaceutical Development, concepts, and industry best practices.
Excellent problem solving, troubleshooting, and experimental design skills with extraordinary attention to detail.
Excellent communication skills. Able to prepare documents including data summaries, technical and analytical reports. Able to present data effectively and ability to communicate effectively with scientists and leadership from a wide range of technical backgrounds.
Excellent interpersonal skills. Respectful and open to other’s views; contribute to building a positive team spirit.
High ethical and quality standards demonstrated through actions and communication.
Small company experiences preferred. The ability to be flexible, nimble working across several deliverables is critical.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.