Clinical Operations Jobs

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: We are seeking an experienced and highly motivated Manager to join our team. This role is crucial in managing feasibility and site agreements to support our clinical programs. The ideal candidate will have extensive experience in feasibility, study start-up, site contact and budget negotiation, and managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations. Role and Responsibilities: Manage and may lead the day-to-day operations within Study Start Up to ensure completion of established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives. Negotiate and finalize site agreements, including budgets, contacts, and other necessary documentation. Provide accurate and up-to-date project status and financial information within relevant tracking systems/tools. Confidently present the budget to the Head of Clinical Operations and Chief Accounting Officer for approval, ensuring full knowledge of all details Partner with Clinical and Finance team to provide study-wide site payment estimates and forecasts. Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contacts Provide regular updates to management on progress and key performance indicators related to trial agreements Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns. Proactively identify and escalate issues that arise related to support functional deliverables. Provide oversight and direction to team members for functional and study-related deliverables. Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period. Build relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU. Contribute to process and tool development to the support of the SSU team with day-to-day activities Under minimal guidance, develop pricing strategies for site budgets to enable contract execution and site activation Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards Build and maintain strong relationships with CROs, FSP providers, and clinical sites Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations Ensure timely and cost-effective solutions that meet project timelines and budgets Address and resolve any issues or disputes related to site agreements Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development Develop and implement innovative ideas and solutions to increase the efficiency of the department Actively participate in Study Team Meetings and work cross functionally with Clinical Operations, Legal, and Finance Provide metrics on study site progress towards activation within local Study Delivery Team and US SM&M leadership as required. All other duties as assigned Re quired Experience, Education and Specialized Knowledge and Skills: Degree in Life Sciences, Business Administration or related field highly preferred; equivalent years of clinical and industry experience will be considered A minimum of 5-7 years experience for manager level, or 10+ years’ experience for Sr. Manager, with feasibility, study start-up, clinical trial site agreements and eTMF in biotech or pharmaceutical setting. Must have knowledge of clinical trial conduct, including multi-center, global trials. Must have strong knowledge of ICH/GCP guidelines and regulatory requirements. Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Experience in working cross functionally and with external providers Experience with development & implementation of process improvement related initiatives Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable Strong computer and database skills Must be able to effectively multi-task and manage time-sensitive and highly confidential documents Work in a fast-paced, demanding, and collaborative environment Knowledge of GCP guidelines and relevant regulatory requirements Strong knowledge of using grant plan or similar benchmarking tool Direct negotiating with sites and vendors is a must Good understanding of the clinical operations process Highly Preferred Skills and Experience: Global Experience with site activation activities including submission requirements. Efficiently manage successful execution of feasibility and study start-up for Global Phase 2 and Phase 3 trials. Strong global negotiation and contract management skills Strong financial acumen and ability to understand and create budgets Experience working with site budgets on a global scale, and potential internal escalation pathway Expertise in large, multi-site, clinical trials with multiple vendor types is preferred This is the pay for this position Pay Transparency $139,000 — $163,000 USD 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. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

COMPANY BACKGROUND TVG-Medulla, LLC is a multi-site healthcare management organization, with an emphasis on providing managed services to chiropractic providers. Medulla provides managed services such as Sales & Marketing, Billing, IT, HR, and Finance to three chiropractic brands, operating under the names of Chiro One, MyoCore, and CORE Health Centers. Medulla is comprised of 830+ employees, with corporate headquarters in Oak Brook, IL and 150+ clinic locations in Illinois, Indiana, Wisconsin, Missouri, Kansas, Kentucky, West Virginia, Texas, Oregon, Washington, and Alaska. TVG-Medulla is a rapidly growing organization, realizing 30%+ growth year-over-year, through a combination of both organic and acquisitive growth. Our vision is to inspire and empower people in our communities to heal, live and function better. All your information will be kept confidential according to EEO guidelines. Disclaimer All team members agree to consistently support compliance and TVG-Medulla, LLC policies and Standards of Excellence with regard to maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, adhering to applicable federal, state, and local laws and regulations, accreditation, and licenser requirements (if applicable), and Medulla procedures and protocols. Must perform other related duties and assist with project completion as needed. Team member may be required to provide necessary information to complete a DMV (or equivalent agency) background check.

Location: Onsite, Hebron, KY Full-time M-F 8:30-5:00   Company Overview Founded in 2015, PHIL is a Series D health-tech startup that is building a platform that interfaces between doctors, pharmacies, and patients to streamline the process of patients receiving prescriptions. This is a complex, archaic industry, and we've set out to change that. Phil’s B2B2C platform provides an end-to-end prescription management and delivery service. Our robust platform connects patients, prescribers, pharmacies, and manufacturers, enabling easy and affordable access to medicine. Through its digital stakeholder experiences, patient access services, market access solutions, and distribution models, pharma manufacturers can deliver affordable and timely therapy access to patients, resulting in more patients staying on their treatment plans longer. Consequently, pharma manufacturers are enabled for more innovation. The team at PHIL is a group of like-minded individuals from varying backgrounds, passionate about creating a new and innovative healthcare platform that is focused on patient experience and overall human wellbeing. Ready to join our team of mission-driven, analytical, and passionate people? Keep reading! Position Overview PHIL is seeking a licensed Pharmacist in the state of Kentucky to support pharmacy operations and ensure high-quality, compliant dispensing of specialty medications in our closed door pharmacy. This role will focus on prescription verification, patient safety, and ensuring timely medication delivery in accordance with state and federal regulations. Reporting to the Pharmacist in Charge, you will play a vital role in providing safe, accurate, and efficient pharmacy services. Responsibilities Verifying prescriptions for accuracy, completeness, and compliance with regulatory requirements Counseling patients when necessary to ensure safe and effective medication use Reviewing patient records and medication histories to identify potential drug interactions or safety concerns Collaborating with pharmacy technicians and operations staff to ensure efficient prescription fulfillment Maintaining accurate records in accordance with state and federal guidelines Participating in quality assurance and continuous improvement efforts within the pharmacy Supporting pharmacy operations in alignment with PHIL’s mission to improve patient access to care Qualifications Bachelor’s degree in Pharmacy or Doctor of Pharmacy (PharmD) Active and unrestricted Ohio pharmacist license in good standing 1–3 years of experience in a retail, specialty, or mail-order pharmacy setting Deep knowledge of state and federal pharmacy laws and regulations Strong attention to detail and a commitment to patient safety Be mobile and remain upright for extended periods of time Occasionally lift of up to 20 lbs and/or exert up to 20 lbs. of force; Frequently lift of up to 10 lbs and/or exert up to 10 lbs. of force; Consistently lift and/or exert a negligible amount of force to move objects. Familiarity with prescription fulfillment systems and electronic health records (EHR) preferred Experience with specialty medications or chronic disease management is a plus Benefits Ground floor opportunity with one of the fastest-growing startups in health-tech Competitive compensation (commensurate with experience) Full benefits (medical, dental, vision) 401(k) contribution opportunity PHIL Inc. is an equal-opportunity employer.