Job Description

Job Description Job Summary My client is a clinical stage company focused on spearheading the development of macrophage- based cell therapies for the treatment of aggressive solid tumors. We are seeking a highly skilled VP/SVP of Clinical, or CMO depending upon qualifications. The VP/SVP/CMO will provide strategic vision and operational oversight for the organization’s medical function. This leader will drive projects through preclinical testing, clinical trials, and dissemination to patients balancing resource allocation, managing risk, and optimizing outcomes to maximize patient impact. The VP/SVP/CMO will collaborate with cross-functional teams and serve as a public representative of the Company and its mission. The ideal candidate values and lives by our guiding principles, the three T’s: ~ Time : We value our time and the time of others.We act with a sense of urgency to accomplish company priorities and keep things moving.We take the time to learn to ensure competency and we take the time to teach. We are all responsible for and take the time to cultivate a positive workplace. ~ Truth : We act with integrity. We build trust internally and externally by being informed and professional, accountable, rationaland transparent. We always do what is best for the patients. We make informed and sometimes hard decisions. We do not avoid discomfort. We confront issues directly to find a resolution. ~ Together : We care about our patients,our company, and each other.We are engaged, mindful, respectful and accountable. We understand that we are stronger together, and take action to ensure internal alignment, execution, and to cultivate a productive and inspiring work environment. Key Responsibilities Include: Lead Medical team from preclinical research through the development and execution of clinical trials. Establish clear objectives, implement efficient processes, and lead a high performing team to execute our mission. Manage projects strategically. Use data driven approaches to prioritize efforts and optimize outcomes. Balance resource allocation, risk and potential. Inspire and lead a high performing team by mentoring, fostering a culture of excellence, collaboration and continuous learning. Ensure clear annual performance objectives and hold regular meetings to review progress. Manage a team of scientists and clinicians who are motivated and empowered to achieve high impact results. Ensure all medical and clinical activities are conducted according to required and necessary health and safety, legal, financial, quality and regulatory compliance requirements in accordance with company and external guidelines. Evaluate protocol proposals from a medical,safety, and feasibility standpoint. Provide medical expertise to ensure data integrity and patient safety. Drive continuous improvements to deliver operational efficiencies and enhanced compliance standards. Work directly with CEO to quickly refine our strategy in solid tumors using experience and extensive collaboration with potential investigators Understanding that we are the first in the world to develop a technology like ours, willing to pioneer clinical trial design and execution, and incorporate state of the art technology, and take the lead to collaborate with the FDA to achieve our pioneering goals Innovators only – in clinical and regulatory design we will make informed rational decisions on how to best use our technology – and if appropriate, we will not look for clinical or regulatory precedent, we will set it. Partner with and lead CROs to effectively execute studies. Build a highly effective and efficient internal clinical operations team Represent the company at conferences, and with stakeholders, key opinion leaders, and investors. Presents complex research in a manner that is understood by all stakeholders. Generates enthusiasm about the potential of our work. Develop and maintain appropriate collaborations and relationships with relevant professional societies, conferences and consortia. Propose annual Medical budget. Monitor monthly and provide insight into deviations and variances. MD or MD/PhD and oncology trained (Board eligible or certified) or foreign equivalent (medical- or surgical- oncology) Extensive biotech and/or pharma oncology drug development experience, I strongly prefer BLA or NDA filing experience Working knowledge of GCP, ICH, US FDA and EMEA regulations Early development, FIH/ FIP, phase 1 dose escalation and proof of concept experience , and late-stage experience are required in solid tumor oncology Experience designing and developing smaller, yet robust and innovative platform trials, proof of concept or randomized phase 2, and registrational Phase 3 studies Prior experience interacting effectively and successfully with regulatory agencies is essential, across the spectrum on FIH/IND, end of phase 2/ pre-phase 3 and (s)NDA/(s)BLA Proven knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products is required. Proven ability to represent the Company’s interests effectively in interactions with external partners, investigators, and regulatory agencies Be aware of current trends and projections for clinical research, practice, and access in the therapeutic area(s) relevant to our product. Qualifications: ~ MD degree with active license. ~ Board Certified in Clinical Oncology is required ~10+years of experience in clinical research and clinical trials. ~ Deep understanding of the biopharmaceutical industry, drug development process, clinical research, clinical program and study design. ~ Demonstrated leadership experience including recruiting, mentoring and managing high performing teams. ~ Expertise in clinical trial decision making,deep knowledge of trial design.Experience designing and executing clinical trial that involve intra-tumor injections a plus. ~ Exceptional communication and presentation skills to convey complex scientific concepts to diverse audiences. ~ Strong strategic thinker with a focus on prioritization, urgency, efficiency and impact. ~ Creative and innovative orientation to clearly identify possibilities and do what has never been done. ~ Oncology experience required with solid tumor experience. ~ Strong leadership qualities is essential

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