Trial Site Solutions Director Jobs

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month). Responsibilities: Responsible for medical monitoring/reporting and safety activities Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies Acts as the medical contact at the company for clinical/medical issues Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel Serve as the medical expert for assigned assets studies Contribute to regulatory interactions and strategy, such as IND/CTA/NDA submissions and briefing packages Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution Oversee and support data int

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology. We are seeking a Clinical Trial Operations Associate to join us in our mission to make brain monitoring easily accessible, interpretable, and actionable. In this role, you will collaborate with clinical research sites, project teams, and internal stakeholders to support the deployment of Beacon’s devices in clinical studies. This role focuses on study startup, site management, and live-study monitoring, ensuring the highest quality standards and compliance with regulatory requirements. This role is fully remote anywhere in the Pacific or Mountain Timezones in the U.S. and will require up to 5% travel. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York, and Paris. What success looks like Collaborate with project teams to support study startup activities. Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication. Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection. Monitor project progress, ensuring adherence to timelines, protocols, and quality standards. Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards. A

Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role focuses on ensuring data integrity and quality for clinical trials across both early and late-stage development, based on portfolio and resourcing needs. The Senior Manager partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. This role is central to ensuring studies are conducted with the highest scientific and ethical standards. The role is also expected to leverage AI tools and other innovative technologies to improve ways of working, enhance efficiency, reduce work redundancy and improve quality. JOB RESPONSIBILITIES Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Authors and reviews key clinical and regulatory documents including, but not limited to, protocols, study-level informed consent forms (ICFs), Investigator's Brochures (IBs), clinical study reports (CSRs), and regulatory submission components. Leads the clinical data review strategy, including the ongoing review of emerging clinical data for safety and efficacy trends. Presents relevant data to internal teams, governance bodies, and other stakeholders. Collaborates with cross-functional team members (e.g., Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology) to ensure trial objectives are met and activities are executed seamlessly. Provides scientific and clinical input for site training materials and supports responses to questions from investigators and site personnel regarding the protocol and study conduct.

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology. We are seeking a Clinical Trial Operations Associate to join us in our mission to make brain monitoring easily accessible, interpretable, and actionable. In this role, you will collaborate with clinical research sites, project teams, and internal stakeholders to support the deployment of Beacon’s devices in clinical studies. This role focuses on study startup, site management, and live-study monitoring, ensuring the highest quality standards and compliance with regulatory requirements. This role is fully remote anywhere in the Pacific or Mountain Timezones in the U.S. and will require up to 5% travel. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York, and Paris. What success looks like Collaborate with project teams to support study startup activities. Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication. Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection. Monitor project progress, ensuring adherence to timelines, protocols, and quality standards. Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards. A

Head of Global SEO/AEO We’re looking for a data-driven Head of Global SEO/AEO to own our worldwide organic growth strategy and execution . In this role, you will scale SEO and Answer Engine Optimization (AEO) into high-performing acquisition channels, driving results against business-critical metrics like trial starts, MQLs, and pipeline . You will manage an in-house team alongside external agencies and contractors, pioneering our approach to AI-mediated discovery to win in the new AI-search era . This role is b ased in our San Francisco or Vancouver office with an office-centric hybrid schedule . The standard in-office days are Monday, Tuesday, and Thursday . Most Asanas have the option to work from home on Wednesdays . Working from home on Fri days depends on the type of work you do and the teams with which you partner . If you're inte rviewing for this role, your recruiter will share more about the in-office requirements . What you’ll achieve Set the global organic strategy and roadmap, owning SEO/AEO as growth channels feeding our PLG & SLG GTM motions, directly accountable for hitting trial starts (PLG) and MQLs/pipeline (SLG) targets . Build the business case for investment in SEO/AEO, owning the channel forecast, budget, and reporting cadence for executive leadership . Own and evolve our end-to-end AEO strategy by bringing proven frameworks, building measurement for brand visibility and citation in AI answer engines, and setting the standard for AI-mediated discovery . Direct our SEO content roadmap and agent-led content strategies, recommending content that matches search/prompt intent, wins against competitors, and converts traffic . Partner with Marketing Ops and Analytics to build attribution and measurement infrastructure tying organic activity directly to PLG and SLG conversion to prioritize roadmap decisions . Lead technical SEO strategy (site architecture, structured data, Core Web Vitals, international/multi-region SEO) and direct content/link-bu

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Associate Director/Director, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. Reporting to the Senior Director, Biostatistics, the Associate Director/Director, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs). Additionally, the Associate Director/Director, Biostatistics will manage Contract Resource Organization (CRO) partners in the creation of statistical outputs, with hands-on quality checks of the outputs. This role will contribute to Clinical Study Report (CSR) writing, and regulatory submission documents. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully r

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position As a Senior Site Reliability Engineer at Formation Bio, you will build and operate the infrastructure, delivery systems, and operational practices that allow our engineering organization to ship reliable software quickly and safely. You will work across cloud infrastructure, developer platforms, observability, and production workloads, including product applications, internal tools, data systems, and ML and AI workloads, taking problems from initial diagnosis through implementation and production adoption. Formation Bio is an AI-native engineering

ABOUT BASETEN Baseten powers mission-critical inference for the world's most dynamic AI companies, like Cursor, Notion, OpenEvidence, Abridge, Clay, Gamma, and Writer. By uniting applied AI research, flexible infrastructure, and seamless developer tooling, we enable companies operating at the frontier of AI to bring cutting-edge models into production. We're growing quickly and recently raised our $1.5B Series F , led by Altimeter Capital, Conviction Partners, and Spark Capital. Join us and help build the platform engineers turn to ship AI products. THE ROLE As a Site Reliability Engineer at Baseten, you'll define and codify the gold standards of day 2 operations for our ML infrastructure platform. You'll envision and build robust systems, processes, automations, and observability tooling that keep our platform reliable at scale — and that empower the broader organization to operate confidently. You'll work closely with engineering, forward-deployed and product teams: learning from recurring failure patterns, turning tribal knowledge into automated mitigations, and raising the operational floor for the entire company. EXAMPLE INITIATIVES You'll work on projects like these as part of the SRE team: Improve Baseten SRE Practices, by instrumenting SLOs and SLIs, improving alerting and observability for all services. Building AI-assisted tooling for incident triage and response. RESPONSIBILITIES Own the reliability of Baseten's multi-cloud Kubernetes infrastructure, including incident response, post-mortems, and remediation tracking. Build and maintain observability infrastructure — metrics, logging, dashboards, and alerting — as code. Author, validate, and improve runbooks for recurring failure patterns, ensuring they're structured for low-context, safe execution. Identify high-frequency failure patterns and convert them into automated mitigations or self-healing automations. Diagnose and resolve runtime issues related to latency, memory behavior, GPU utilization, concu

Why Patients Need You Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. What You Will Achieve As part of the Comparative Medicine team, you will support the Research & Development site by managing a vivarium to deliver flawless animal care and welfare and will assure the quality of care and the animal facility environment is in compliance with local regulations and AAALAC International guidelines partnering with Research and Development Research Units and Partner lines to facilitate study support. It is your hard work along with innovative ideas and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Assure that the care and welfare of laboratory animals is provided in compliance with local regulations and AAALAC International guidelines. Manage and engage animal care and technical staff in the pursuit of flawless animal care and welfare by ensuring adherence to established policies and procedures. Support the career and personal development of the animal care and technical staff. Assist with a centralized CM training program for research animal care and use for animal care staff, principal investigators and research technicians throughout WRD. Participate in the direction of a centralized CM program of occup

About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com . Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com . Overview The IT Support Analyst II will play a key role in supporting on-site Iovance staff in Philadelphia, as well as other U.S.-based Iovance offices remotely. The ideal candidate will bring strong troubleshooting, communication, and customer service skills to help resolve IT helpdesk tickets and maintain reliable end-user technology across the organization. **Please note that this position is fully onsite at our Manufacturing Facility** Essential Functions and Responsibilities Provide support for the

Associate/Laboratory Director of Oncology, Comprehensive Genomic Profiling Position Summary As an Associate Lab Director or Lab Director of Oncology, you have clinical oversight of Natera’s laboratory testing related to cancer testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. You are responsible for ensuring the test validation and development meets all required regulatory standards. This position will be primarily responsible for technical and clinical performance of Natera’s comprehensive genomic profiling (CGP) assays. Title and scope of responsibility will be commensurate with the candidate’s experience. This position is on-site at Natera’s San Carlos, CA Laboratory. Primary Responsibilities Provide clinical sign-out and interpretation for CGP reports, identifying actionable biomarkers and relevant clinical trials Provide technical and clinical support for laboratory staff, genetic counselors, and other clinical personnel Ensure acceptable levels of analytical performance for CGP assays, compliance with applicable standards, and laboratory inspection-readiness at all times Troubleshoot workflow and laboratory issues with clinical care and regulatory standards in mind Document findings and maintain accurate records consistent with Natera policies and procedures May serve as Clinical Consultant . A Clinical Consultant is responsible for ensuring: Test reports include pertinent information for test interpretation, and Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions Qualifications Education: MD/DO and/or PhD in genetics or related field required. Board Certification: ABMGG board-certified in Clinical Cytogenet

About Anthropic Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing group of committed researchers, engineers, policy experts, and business leaders working together to build beneficial AI systems. About Anthropic Anthropic's mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing group of committed researchers, engineers, policy experts, and business leaders working together to build beneficial AI systems. About Beneficial Deployments Beneficial Deployments ensures AI reaches and benefits the communities that need it most. We partner with nonprofits, foundations, and mission-driven organizations to deploy Claude in education, global health, economic mobility, and life sciences — focusing on raising the floor for those who need it most. About the Role We're looking for an Applied AI Engineer to join our Beneficial Deployments, Life Sciences team. This is a partner-facing role: you'll support nonprofits, research institutes, academic medical centres and public-sector funders as they use Claude to get treatments to patients with rare and neglected diseases, where there is little or no commercial incentive to fund development. The role focuses on clinical development, where we think Claude can help these partners today. Trials in these diseases have small patient populations, investigator-led or nonprofit funding and little operational support, and they often stall on protocol quality, operational risk and site start-up. Claude can help teams design better trials and start them sooner. Much of this work is drug repurposing: testing new uses for approved, usually off-patent or generic medicines, whose known safety profiles can let a good hypothesis reach patients years sooner than a new molecule. You'll

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in this mission! You will be responsible for supporting Kite’s strategy for representativeness and inclusion in clinical trials in partnership with the multi-year vision for trial equity and optimization. This strategy includes building and nurturing community and advocacy relationships, building awareness internally and externally, driving health literacy, designing diversity into programs and studies, enabling clinical trial patient participation, and improving clinical trial participant outcomes. This role will transform the success of participation and retention of diverse populations that are representative of the global epidemiology of the disease states where we are pursuing treatment, and curative t

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position Clinical trials are where drug development actually gets slow and expensive. Sites take months to activate. Data arrives late, in fragments, from a dozen systems and vendors that don't talk to each other. People spend their weeks reconciling spreadsheets instead of making decisions. The Trial Execution team exists to fix that, and this role is a senior seat on it. The constraint that makes this interesting: our trials run in a regulated space. Systems that touch patient safety or trial integrity are GxP-relevant, which means computer system validat

About the Role You'll own the technical and operational execution of the trial from kickoff to decision, acting as the connective tissue between Sales, Product, and the customer during the evaluation window. You'll be the single point of accountability for trial execution. Key Responsibilities Trial Execution: Own the technical and operational execution of each enterprise trial from kickoff through the customer's final decision, including environment setup and configuration. Requirements & Scoping: Gather and scope technical and operational requirements directly with the customer's technical and legal ops stakeholders. User Enablement: Design and deliver training so prospect teams can meaningfully evaluate the product, not just log into it. Issue Triage & Escalation: Identify and triage issues that arise during the trial, escalating to Product or Engineering as needed to keep the trial moving. Project Management: Own the trial timeline and success criteria, hold both Eudia and the customer accountable to them, and flag risk to the deal team early. Cross-Functional Connective Tissue: Act as the primary link between Sales, Product, and the customer during the evaluation window, and translate trial outcomes into a clear, evidence-based case for close. What We're Looking For 1-2 years of experience; recent graduates encouraged to apply. Strong organizational skills. Comfortable tracking multiple timelines, tasks, and stakeholders at once. Clear, professional written and verbal communication; comfortable presenting to and training customer teams. Interest in learning technical/product concepts quickly and explaining them to non-technical users. Detail oriented and reliable in following up on open items and closing loops. Comfortable working directly with customers and cross-functional internal teams (Sales, Product). Willingness to travel for customer meetings and onsite trial support as needed. Preferred (Nice to Have) Internship or coursework involving customer