Kelly

  • Houston, TX


  • Permanent

  • Full-time

Combining the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. Operating from Tuebingen, Munich and Houston, we are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. We are currently seeking a Full Time DIRECTOR OF CLINICAL OPERATIONS US for our CLINICAL OPERATIONS DEPARTMENT to support our team. This position will preferably work in Houston, Texas (however East Coast location (New York/New Jersey area) may be acceptable) and will be responsible for the execution of clinical trials and clinical programs. The position will report to the Senior Director, Head of Clinical Operations in Germany. *The main responsibilities of this position will include but are not limited to the following tasks:* * Lead a cross functional internal team with line management responsibility. * Ensure personal development of Clinical Operations’ staff. * Develop plans to grow the US Clinical Operations team, as needed according to the company’s strategic planning. * Establish working practices ensuring a culture of quality, compliance, and inspection readiness at all times. * Oversee US clinical trial execution to ensure completion on time, within budget and in compliance with SOPs, regulations, and ICH and GCP guidelines. * Provide stakeholder management by actively interfacing with representatives from key functional groups, including but not limited to, Clinical Development, Data Management, Biostatistics, Regulatory Affairs, QA, Medical Writing, CMC and Research. * Ensure risk management for clinical trials. * Develop consistent metrics to measure project success and team performances. * Engage with vendors/partner and lead clinical vendor procurement activities. * Maintain a vendor governance and ensure sponsor oversight. * Ensure that Clinical Operations’ SOPs reflect current clinical operations’ practices. * Oversee clinical trial initiation activities including protocol development, activities for clinical trial site selection and regulatory submission, investigator budget and contract negotiations. * Communicate clinical trial status regularly to key stakeholders regarding quality, costs and timelines and escalate unresolved issues to Senior Management. * Provide expertise, training, and guidance on Clinical Operations activities. *The qualifications for this position include, but are not limited to the following:* * Bachelor’s Degree in Biological Sciences or related field. Masters or Ph.D. preferred. * Must have 7 to 8 years of experience in the pharmaceutical and/or drug development industry. * Experience with line management for a team required to deliver time-sensitive objectives. * Experience managing remote employees preferred. * Thorough understanding of and experience with the drug development process through multiple clinical trial phases (e.g., Phases I through IV). * Knowledge of ICH GCP, FDA regulations and other guidelines. * Experience with outsourcing to clinical research organizations or drug development partners. * Practical experience performing project management for a cross-functional project. * Practical experience in initiating, maintaining and terminating clinical trials in the role of clinical operations/development within industry. * Experience with budget development, negotiation, forecasting, and finance processes. * Strong team player with clear communication style and strong empathy. * Open mind, appreciating different cultures. * Patient-centric mindset. • Innovative mindset, think outside the box. * Enthusiasm, leading to constant striving for excellence. * Working style: independent, proactive, flexible, result-oriented, analytical reasoning. * Excellent time management and organizational skills. * Taking individual responsibility. * Ability to adapt to rapidly changing requirements. * Flexibility to adapt in a cross-functional and dynamic “start-up” type of environment. We expect a high degree of independent working, analytical reasoning and excellent communication skills. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills. Why Kelly®? 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. About Kelly® 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](https://www.mykelly.us/us-mykelly/perks/)?). 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.](https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) ]]

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