Clinical Operations Jobs in Pharma & Biotech

Director IVD Strategy & Operations - Precision Medicine Unit What you will do In this vital role you will work closely with the PMED Head of Strategy & Ops. and Head of CDx, as well as a number of cross-functional Dx stakeholders (Regulatory, Quality, Safety, Medical, Commercial, etc.) to advance the development and delivery of IVD/Dx strategies. You will serve as the lead and steward of a cross-functional team in charge of driving cross-functional decisions and alignment regarding Amgen’s position and strategy to align with global IVD regulations including IVDR in EU, new LDT regulations in US, etc. Additionally,...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Clinical Lab Associate I, Specimen Processing is responsible for performing the day-to-day operations of the Specimen Processing Department including, but not limited to, lab productivity and process line support, such as accessioning, processing, automation usage, sample racking,...

Seeking a highly organized, motivated and proactive individual to join our dynamic team. Reporting to the Director of Medical Science, the Project Coordinator III is responsible for providing administrative support, managing project and program activities, and facilitating smooth communication internally and with external stakeholders. The ideal candidate will have strong multitasking skills, excellent communication abilities, and a knack for problem-solving. Position Responsibilities; Performs the following tasks with limited supervision Manage calendars, schedule meetings, and coordinate logistics for teams Prepare and distribute meeting agendas, minutes, and follow-up action items Handle correspondence and communication with internal and external stakeholders Maintain organized filing...

The responsibilities pertaining to this job will require the selected employee to monitor compliance of the permit requirements in the facility. This includes but is not limited to managing regulated waste, conducting all regulated inspections of EHS Programs. Support the implementation of EHS Program in operational areas. This role will report to Villalba site and will report to EHS Sr Manager. Responsibilities may include the following and other duties may be assigned. Develops, administers and implements environmental, health, and safety programs in accordance with governmental requirements. Conduct environmental inspections for regulated programs, SPCC, SWPP, PRASA, WELL. · Operates the hazardous...

The Clinical Research Associate will advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. This role will be assigned investigative sites in the Phoenix, AZ area. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. Considered as the primary point of contact for the investigative site....

The Clinical Research Associate will advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. This role will be assigned investigative sites in the Chicago, IL area. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. Considered as the primary point of contact for the investigative site....

Job Function Clinical Operations Sr Manager, Budgets & Contracts Level M4 The Senior Manager, Clinical Budgets & Contracts is responsible for strategic oversight and execution of clinical contract and budget operations. This role provides leadership to a team supporting clinical trial start-up and lifecycle management, ensuring timely, compliant, and cost-effective contracting with investigational sites and third party suppliers. This role leads a team responsible for an assigned functional stream (NDAs, Site Contracts / Budgets, Vendor Contracts / Budgets, Payments…) while partnering closely with study teams, Legal, Finance, and/or AP to drive process excellence and scale operations to meet...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Clinical Laboratory Scientist is responsible for performing standard laboratory procedures within the assigned department/laboratory. The Clinical Laboratory Technician will analyze data and may assist with research and development. This incumbent will be relied upon to follow laboratory...

Manager, Trial Delivery Management, Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Manager, Trial Delivery Management, Oncology to be located in, Beerse, Belgium; Leiden, Netherlands; Madrid, Spain; Warsaw, Poland; High Wycombe, United Kingdom; Toronto, Canada; or in Spring House, PA or...

We are searching for a Director, Precision Medicine Value and Access. The position will be based in Horsham, PA. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at It is imperative that J&J’s commercial model adapts to accommodate the nearly 50% of the anticipated precision medicine enabled assets launching in the...

Clinical Research Medical Sr. Director - Thoracic Oncology What you will do In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indication(s). Additional responsibilities include Provide therapeutic area expertise in thoracic oncology and drive development, execution, and communication of the global scientific/medical evidence plan for small cell lung cancer area, including leading the evidence generation team. Serve as global development lead for specific small cell lung cancer indications and/or patient impact expansion (PIE) strategies. Integral contribution...

The Associate Principal Scientist is a DVM/VMD and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study. The Associate Principal Scientist can also be responsible for several effectiveness studies within a project, participating as the clinical representative in project...

The CoreValve Therapy Development Specialist provides technical, clinical, educational and sales support to ensure safe adoption and growth of the Medtronic CoreValve System and future catheter-based therapy technologies. The CoreValve Therapy Development Specialist works closely with implanting teams and the Medtronic Catheter-based Therapies (CBT) and CVG field organizations to drive procedural and practice success. Technical and Clinical Support Provide clinical expertise for TAVR implanting centers, including “scrubbing in” for TAVI implant procedures to assist with loading valves onto delivery catheter, and providing technical support in accordance with the instructions for use/trial protocol, and best-practices to facilitate procedural consistency and best...

This position works out of our Plano, TX location in the Neuromodulation Division . Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Under indirect supervision, the Facilities Coordinator oversees and coordinates the day-to-day building operations and services, ensuring occupants work environment is conducive to maximizing productivity and workspace comfort. Candidate will ideally come from the hospitality industry or have experience interfacing with senior client / customers. Candidate must be highly organized...

The Sr. Clinical Research Director, Core Surgical Innovations (CSI) reports to the VP, Clinical Research & Medical Science, Surgical. This position is responsible for directing all global clinical research activities and programs to generate clinical evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business, R&D and commercial strategies for the CSI Business Unit. The leader is also responsible for designing and driving the execution of pre-market and post-market clinical trials globally, including driving outcomes and results, and collaborating for the dissemination of the resulting evidence to internal...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The Trial Capabilities Assistant role provides technical support to the...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Associate Director– Clinical Trial Foundations Purpose The Associate Director, Clinical Trial...

About the job Your skills could be critical in helping our teams accelerate progress. Join our Fitusiran Clinical Team as Senior Clinical Research Director and you will be the primary Clinical Lead for Phase 3 registrational studies and on-going NDA submissions. Qfitlia (fitusiran) is a first-in-class AT lowering therapy approved by the US FDA for prophylactic treatment of adults and pediatric patients We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment,...

Twist Bioscience is looking for an individual that is highly motivated, collaborative, takes pride in their work, and great attention to detail. This position will play a critical role in forming a best in class Shipping/Order Fulfillment team. This position will require interactions with Manufacturing, Customer Support, Receiving, Warehouse, and Supply Chain teams to ensure internal and external customer satisfaction while ensuring all orders are processed and shipped in a timely and required manner. The Shipping Coordinator II will perform all administrative and physical requirements of this position. What You’ll Be Doing ●Pick & Pull products in accordance to the...

POSITION SUMMARY The Logistics Coordinator will support operational activities related to the inbound and outbound transport of biological specimens and collection kit manufactured products. Responsibilities will include tracking specimens from the point of pickup through delivery. Employees will act as a liaison between Customer and both external and internal partners. Job assignments should be managed without immediate supervision and evaluated based on performance. Individuals must be able to perform each essential core function as well as monitor and maintain the department service levels. All work is subject to additional requests as assigned by Department Manager. Coordinates and consolidates domestic...

POSITION SUMMARY The role of Patient Coordinator will be central to the success of the Prospera product line. This position will be focused on growing the relationship between Natera and its patients to ensure timely management of testing. Core responsibilities include collaborating with Nurse Coordinators to increase revenue and drive market development through direct sales by being the key contact for patient needs. The Patient Coordinator will accomplish this by being the patient advocate within Natera. *Spanish strongly preferred* PRIMARY RESPONSIBILITIES Work with assigned Nurse Coordinator to maintain & support existing customers. Assess the needs of patients with a...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Location Remote position within the United States Travel up to 25% (domestic and may include international travel). In this exciting role as a Clinical Research Manager (CRM) , you will have primary focus responsibility to oversee all clinical activities related to one or more clinical studies and performing/directing/managing the daily in-house activities associated with the studies. This is a people leadership role. The CRM will report to the US Sr. Clinical Research Manager and independently handle various clinical study assignments, have management responsibility, and oversees and directs the work of a team of Clinical Research Specialists at all levels, from...

Accelerating the execution of our priority clinical trials is an imperative and a critical enabler of our Drug Development strategy to launch 10 new treatments in 30 new indications by 2030. At the center of our acceleration efforts is methodology and ability to assemble wide-ranging data - structured, tactical and ad hoc - into timely insights which then support precision actions. The Executive Director, Trial Analytics , Insights and Planning (TAIP) is accountable for driving end-to-end analytics excellence within Global Development Operations (GDO) and is a key function within the Trial Delivery Support team. In this steady-state model, the Executive...

Johnson & Johnson is hiring for a Clinical Research Associate II - Shockwave Reducer (Remote) to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly...

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning,...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

PRIMARY RESPONSIBILITIES Review select cases for accuracy of tissue request and escalate to PA’s when needed, complete accurate data entry. Assist other PSCs in resolving issues with their cases and provide feedback on the quality of their work. Ensure that necessary notes and holds are placed on cases for non-conforming samples, discrepancies and/or missing information so that timely follow-up by the Customer Care team is made. Compose professional emails/faxes using proper grammar and spelling to communicate with other departments for case escalation and/or case status updates. Perform outbound calls to pathology labs for specimen information (confirmation of accession numbers, specimen...

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Precision Medicine Field Director (PMFD) you will provide inspirational leadership and prioritize to drive high performance through your regional Precision Medicine Manager team. As a role model, coach and a liaison you will...

Patent Coordinator - IP Litigation Administrative Coordinator What you will do In this vital role you will will provide administrative support to the Intellectual Property Litigation team. The successful candidate will provide support to the Intellectual Property Litigation team by assisting and supporting our litigation teams in the U.S. and global intellectual property litigations, including maintaining electronic databases. Candidate will also draft correspondence, e-mails, engagement letters with outside counsel; obtain references, case law, patents, file histories; organize materials, etc. The work assignments are sometimes complex in nature and require absolute discretion, as well as considerable tact, judgment, creativity, and...

We are searching for the best talent to join our Vision team as a Staff Clinical Research Scientist located in Jacksonville, FL Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for...

The Clinical Trial Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. Serves as a primary source of medical accountability and oversight for clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 – Phase 3 studies, with demonstrated decision making capabilities Provides medical and scientific expertise to cross-functional BMS colleagues Medical Monitoring Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a...

About Synchron Synchron is a clinical-stage endovascular brain computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. The Synchron Switch ™ BCI received FDA Breakthrough Device Designation in 2020, and is currently in human clinical trials in the US and Australia. The company recently announced an oversubscribed $75 million Series C financing round led by ARCH Venture Partners, with participation from Gates Frontier, Bezos Expeditions and other top-tier investors. The funds will accelerate product development, facilitate commencement of a pivotal clinical...

Job Title Global Therapy Development Specialist We currently have an opportunity available for a Global Therapy Development Specialist to join our Vascular division. This is a fully Remote MAIN PURPOSE OF ROLE The Global Therapy Development Specialist champions issues that provide major implications for the company and may lead to accomplishing long-range objectives for US and OUS geographical areas. Provides broad, technical advice. Mentors sales trainers, marketing, and field sales personnel by sharing clinical and technical expertise and providing feedback and guidance. Acts as an advisor to management on specialized business projects (managerial, technical, leadership, clinical, training). Acts as...

Clinical Research Medical Director, Uplizna What you will do In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s). Provide oversight of LCM clinical development with input on global strategy Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s) Participate and provide clinical input into safety and regulatory interactions. Interpret and communicate clinical trial data. Author/review CSRs, publications, and regulatory submissions Develop key opinion leaders and make...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Through the application of scientific and medical training, clinical expertise, and...

POSITION SUMMARY Natera is currently seeking a Clinical Laboratory Associate to analyze laboratory specimens following the standard methods and procedures while maintaining equipment and instruments in good operating condition by troubleshooting malfunctions as needed. PRIMARY RESPONSIBILITIES Assists in testing of patient samples according to standard operating procedure in an efficient manner with little to no errors Responsible for maintaining updated understanding and knowledge of methods performed in the lab Follows GLP (good laboratory practice) maintain cleans and organized work space Completes training and other deadlines on time. Recognizes and escalates equipment malfunctions; troubleshoots common errors on the lab floor Recognizes,...

This Director, Clinical Trial Physician (CTP), Oncology, Medical Evidence Generation (MEG) role in Medical Affairs manages set of studies within the evidence generation Oncology/Hematology portfolio (including Medical Affairs Sponsored studies [MAST], Clinical Research Collaborations (CRCs), and Investigator Sponsored Research (ISRs) – and provides clinical support for other studies in the MEG book of work (BOW). In this role, he/she will serve as the primary source of medical/clinical accountability and oversight for studies in alignment with the Integrated Evidence Plans (IEP) for specified assets. He/she will work closely with Worldwide Medical (WWM) Therapy Asset Lead, the MEG Oncology Lead, and other...

This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of families around the world. Working...

*** This is an in-clinic position in Englewood, NJ *** A Natera Test Coordinator Phlebotomist serves patients by scheduling and identifying the best method for retrieving blood; preparing specimens for laboratory testing; and reconciling paperwork requirements as needed. PRIMARY RESPONSIBILITIES Split clinical and administrative duties Patient communications, including draw and timing requirements. Administrative duties, such as accessing patient information and reports in Electronic Medical Record (EMR), scheduling patients, aligning available blood draw times to clinic requirements, etc. Work from home time to be noted on timecard, submitted weekly Requires tracking and data entry for each drawcompleted, including billing information when...

This is a Remote Based position and will be covering a Southeast area (may not be limited to). Candidate must be located near an airport (Florida/Georgia/Alabama area -highly desirable locations). The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials within the country. The Senior CRA is responsible to deliver data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. LI-#Remote...

Job Overview We are seeking a very experienced and highly motivated individual to join us as an Administrative Assistant to support the Site Head of our Manufacturing Operations as well as his team in La Verne, California. Provide administrative leadership and support to a large, highly matrixed Functional group requiring proactive coordination across the site while also working collaboratively with other site administrative staff. You may be asked to assist in areas outside of your primary responsibilities. The ideal candidate will be customer service oriented, flexible, proactive, a critical thinker and resourceful with a high level of professionalism, confidentiality, and...