Senior clinical scientist jobs near me

The Pharmaceutical Development Scientist is a hands-on technical role responsible for the formulation, development, optimization, and technology transfer of sterile and non-sterile drug products across STAQ Pharma's 503B Outsourcing Facilities. Reporting directly to the Chief Pharmaceutical Officer, this position supports product development initiatives from concept through scale-up and commercialization, driving innovation, process improvement, and lifecycle management of compounded drug products. The scientist collaborates closely with Manufacturing Sciences & Technology (MS&T), Quality, and Production teams to translate laboratory-scale formulations into scalable, validated CGMP manufacturing processes. Responsibilities include conducting pre-formulation and compatibility studies, preparing R&D and pilot-scale batches, and analyzing analytical and stability data to identify optimal formulations that maximize quality, performance, and product expiration dating. This role requires strong analytical chemistry expertise-including the ability to interpret UPLC chromatograms, assess impurity profiles, and apply ICH and FDA 503B guidance-to guide formulation strategy, product development, and technology transfer activities. Key Responsibilities: Develop, optimize, and scale formulations for sterile and non-sterile dosage forms in compliance with CGMP, FDA 503B, and ICH guidelines. Conduct pre-formulation studies, excipient compatibility testing, and stability evaluations to inform formulation design and shelf-life optimization. Design and execute experiments to assess formulation feasibility, process robustness, and long-term product stability. Prepare and manufacture laboratory-scale, R&D, and pilot-scale batches for testing and process development. Lead and support technology transfer activities for new and existing products, ensuring seamless transition from R&D to manufacturing and between STAQ Pharma sites. Conduct literature reviews and data analysis to identify innovative formulation approaches and support development strategy. Analyze data from HPLC, GC, dissolution, and stability studies to assess potency, purity, and impurity profiles. Collaborate with MS&T, Quality, and Production teams to ensure manufacturing processes are robust, validated, and scalable. Develop and execute stability protocols, trend data, and prepare detailed technical summaries and reports. Write and maintain technical documentation, including batch records, development protocols, SOPs, and technical reports in accordance with CGMP standards. Support investigations of out-of-specification (OOS) or out-of-trend (OOT) results and contribute to CAPA development and implementation. Participate in audits, inspections, and internal quality reviews to ensure regulatory and operational compliance. Qualifications: Bachelor's, Master's, or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline. Minimum of 3-5 years of hands-on experience in CGMP pharmaceutical formulation or product development (503B, CDMO, or sterile pharma manufacturing preferred). Demonstrated experience in formulation design, stability testing, and technology transfer. Proficiency in analytical chemistry techniques, including UPLC, GC, and dissolution testing; ability to interpret chromatograms and impurity profiles. Strong working knowledge of ICH Q8-Q10, FDA 503B guidance, and applicable USP chapters. Experience in scale-up and process optimization for aseptic and non-sterile drug products. Excellent technical writing, communication, and organizational skills. Ability to work independently, prioritize multiple projects, and collaborate effectively across cross-functional teams and sites.

About Radionetics Radionetics Oncology, Inc. is a clinical stage radiopharmaceutical company focused on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics. Radionetics Oncology spun out of Crinetics Pharmaceuticals (Nasdaq: CRNX) and is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments. Radionetics is advancing a pipeline of novel small molecule radioligands targeting G-protein coupled receptors for the treatment of a broad range of cancers, including adrenocortical carcinoma, breast cancer, lung cancer, among others. For more information, visit ************************ The Director/Senior Director, Clinical Scientist reports directly to the Chief Medical Officer and plans, implements, and manages assigned clinical research studies in collaboration with internal and external stakeholders to ensure trial integrity and success. The Clinical Scientist provides strategic input and development support for clinical plans, evaluating and interpreting clinical data reviewing and authoring study-related documents, monitoring patient data and data collection status, and delivering protocol-related training to CROs and clinical trial sites. The Clinical Scientist provides support for preparation of regulatory submissions necessary for the initiation of clinical studies. This position is a key cross-functional team member contributing to the design and execution of the company's clinical trials. Essential job functions and duties Support the creation of the clinical development plan in partnership with cross- functional team members as well as KOLs and CROs. Author, manage, and review study materials for competent authorities' submissions; gain insights from clinical and scientific experts (e.g. protocol, regulatory documents, study report, safety review and communication). Analyze and interpret clinical trial data, collaborating with clinical operations to conduct data review. Troubleshoot internal and external conflicts to ensure trial integrity and success. Develop and present protocol training for CROs and trial sites. Engage with trial sites and CROs on an on-going basis to monitor subject data and data collection status, ensure adherence to protocol, and evaluate consistency of data. Maintain knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to help ensure best practices. Establish excellent communication and collaboration with the cross-functional partners within the company and outside of the company. Deliver timely, high-quality clinical study data, working in concert with external and internal partners. Collaborate with clinical operations to identify, recruit, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators to prioritize enrollment and ensure timely and high-quality execution of clinical studies. Support clinical operations in the selection, contracting, and oversight of CROs and vendors in assigned projects. Work closely with clinical department team members and other stakeholders to develop and drive patient accrual strategy to meet appropriate corporate timelines. In assigned projects, lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRF's, DMP edit checks, safety plan, Safety Management Team and DMC charter, close-out plans, inspection readiness plans, and CSRs. Lead the development of study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring boards. Lead in writing publications and scientific presentations. Perform other responsibilities as required by business needs. Minimum required qualifications Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred. Minimum 10 years (director) or 12 years (Senior director) of experience with 5+ years as a Clinical Scientist or comparable role. Solid knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution. Experience in a scientific discipline with clinical drug development experience and strategic planning specifically in the pharmaceutical or biotech industries is preferred; however, other relevant experiences and skills may be considered. Experience in oncology is preferred, radiopharmaceutical experience is a plus. Highly motivated and thrives working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations. Self-starter who can lead and manage function independently, while utilizing sound judgment. Non-standard work schedule, travel or environmental requirements The position is based in San Diego, CA; a portion of the job duties may be performed remotely. Domestic and international travel may be required up to 25%. Compensation & Benefits Radionetics has a competitive total compensation package that includes bonus opportunity; equity; medical, dental, vision, life, short-term, and long-term disability insurance; 401(k) retirement plan; 4 weeks of paid time off (PTO) annually; and generous paid holidays. Pay Range: $208,000 - $240,000 (director range); $250,000 - $280,000 (sr. director range) Radionetics evaluates a variety of factors in determining individual pay decisions, which may include relevant education, experience, and skills; internal equity; complexity and responsibility of the role; and market demand relative to the position. Geographic location may also be a consideration in evaluating salary when candidates work in states outside of California. Important notices Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class. The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time. Radionetics does not accept unsolicited referrals from employment agencies for position vacancies unless written authorization is provided from the Human Resources department before any candidates are referred for specific identified positions. In the absence of such written authorization, any actions taken by the employment business/agency shall be deemed to have been performed without consent or contractual agreement, and Radionetics shall not be liable for any fees arising from such actions or referrals for position vacancies at Radionetics. Powered by JazzHR PVMo2sgj5Z

About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit *************** As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Clinical Scientist, Clinical Pharmacology Location: Remote-United States OR Hybrid in Menlo Park, CA -or- Waltham, MA Key Responsibilities: As a key member of the Clinical Pharmacology team, this individual will be responsible for pharmacokinetic modeling , analyzing clinical PK data using non-compartmental analysis, engaging in translational research efforts and exploring exposure/response relationships using data from our clinical and non-clinical development programs. In addition, the role will be integral to developing effective models using preclinical and clinical data to assess Oruka's strategic emphasis on creating best in class treatments. Furthermore, this role will likely include responsibilities for developing and executing translational plans beyond pharmacokinetics. As such, you will Design and implement appropriate clinical modeling to contribute to successful clinical development plans and to drive rapid development. Author clinical pharmacology aspects of clinical study protocols, analysis plans, reports, and related regulatory and clinical documents. Perform non-compartmental analyses (NCA) of our clinical PK data Influence the development of drugs and expand the application of model-informed drug development (MIDD) approaches across our portfolio. This will include the planning and execution of quantitative analyses which may include population pharmacokinetics and pharmacokinetics (PK)/pharmacodynamics (PD) exposure response. Engage with and manage outside vendors, partners and consultants as necessary, including oversight and review of PKPD analyses conducted by third party vendors. Support internal modeling and analysis outside of Clinical Pharmacology including working with Non-Clinical data and colleagues and supporting Corporate modeling efforts. Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships Manage translational research efforts associated with clinical trial objectives by working with academic collaborators You will partner with key stakeholders and colleagues including Development teams and leaders. You will interface closely with non-clinical scientists to facilitate modeling and data analysis in the non-clinical programs. Influence and lead the external environment through scientific societies, publications, presentations, and collaborations Qualifications: Bachelor's degree and 10 years of experience or master's degree and 8 years of experience in life sciences, pharmaceutical sciences, pharmacology with 8 years of experience in conducting clinical pharmacology studies including study design, PKPD data analysis, and interpretation of results. PhD in Pharmaceutical Science, Math or related discipline preferred. Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics) Working knowledge of PKPD modelling approaches (including population PKPD approaches), bioanalysis, data analysis and biostatistics, programming, broad familiarity with the drug development process. Extensive hands-on Phoenix WinNonlin experience, R, SAS, NONMEM, or other PKPD data analysis or modeling platforms preferred. Strong attention to detail with extensive experience reviewing and interpreting complex PK and PD data. Strong interpersonal skills, with the ability to work across cross-functional teams. Project management skills with sense of urgency, ability to collaborate and influence across teams. Demonstrated ability to work across functions including medical writing, clinical operations, biometrics, clinical development, quality and regulatory affairs. Excellent communication skills, both verbal and written, with the ability to convey complex data concepts to stakeholders at all levels. Compensation: An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. The anticipated salary range for candidates, is $175,000 to $ 200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. Job Location: Position may be remote, if the candidate lives near one of our offices in either Menlo Park, CA or Waltham, MA, candidates will be required to be in-office in 3 days/week. Salary Range for the Role$175,000-$200,000 USD What We Offer: A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients. Competitive salary and benefits package. A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work. Opportunities for professional growth and development.

Job TitleSenior MRI Clinical ScientistJob Description As an important member of the Philips North America MRI Clinical Science team, the Senior MRI Clinical Scientist will collaborate with medical doctors and physicists of large academic hospitals (most notably University of Texas Southwestern Medical Center) with a focus on research, development, and evaluation of new medical applications for Magnetic Resonance Imaging to include co-creation and collaboration opportunities in the areas of areas of CEST, multinuclear, MR-RT, 7T, MRS, and pediatric imaging., Your role: Will guide, conduct, and support research and advanced clinical applications for the Magnetic Resonance Imaging (MRI) product line at luminary sites in North America. Will be the expert MRI specialist in an assigned technical or clinical application area, build a network in the scientific community and report and advise about new insights and technologies within the Business Unit MR Drive clinical co-creation projects at designated sites to generate transfers of ideas, research prototypes, solutions, and IP for product development and generate evidence to support claims through scientific publications. Be hands-on, be able to independently run the Philips MR scanners and perform volunteer and patient scanning and guide the users on Philips scanner capabilities and development tools. Increase visibility of Philips MR program through lectures and presentation at scientific or professional international conferences as well as involvement in professional organizations. Assist the larger organization in clinical evaluation reports, white papers and materials to support new product introductions. Provide guidance in the sales process to luminary customers through broad MR and clinical expertise. Support dedicated training courses on research tools and clinical capabilities. Collaborates with clinical and research partners to gather insights and feedback on proposed solutions, aiding in the refinement of prototypes and concepts. Authors documentation and publications resulting from clinical studies and other research endeavors, sharing insights and findings with relevant stakeholders to advance knowledge and drive impact. Reporting to the Clinical Science Leader MR for North America, you will partner with multiple teams in the market and the global Business Unit, including Global clinical science, Marketing, Clinical Affairs, Legal, Sales and Global leaders across the company. You're the right fit if: You've acquired a minimum of 5+ years' professional experience beyond a PhD program/academic setting, in MRI/clinical imaging, development on and advanced application of MR systems in a clinical setting, and the ability to conduct research and set up research studies. You have a strong working knowledge of MRI Physics (Required), MR Pulse Programming, reconstruction, and/or AI development experience are strongly desired. You have proven experience writing and overseeing research grants. You have proven experience interacting with customers, market colleagues, and other internal stakeholders. You have excellent communication, teaching, and presentation skills. You're an independent problem solver, with strong analytical and experimental skills. You have a minimum of a Ph.D. in physics, chemistry, biomedical engineering, or comparable disciplines. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This role will be based at the University of Texas Southwestern Medical Center, Dallas, TX and on site 3X per week. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in Dallas, TX is $129,375 to $207,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information: May require travel up to 10%. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Biogen's West Coast Hub is seeking an accomplished and highly motivated Lead Clinical Scientist to provide scientific, strategic, and operational leadership for our organ transplantation clinical development program. This role will help lead the design, execution, and advancement of late-stage clinical trials in antibody-mediated rejection and other conditions in organ transplantation.The Lead Clinical Scientist will play a critical role in ensuring the highest standards of patient safety, data quality, and scientific integrity throughout the clinical development process. This position requires subject matter expertise in solid organ transplantation, the ability to oversee complex global trials, and strong cross-functional and external collaboration skills. The responsibilities of this role may vary depending on the specific indication and trial requirements.Who You AreYou have significant experience in clinical trials for organ transplantation and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients.What You Will DoClinical Development LeadershipHelp lead the design, execution, and analysis of late-stage organ transplantation clinical studies, ensuring alignment with program strategy while adhering to GCP and regulatory requirements Develop and refine clinical development plans, study protocols, and other trial related documents. Medical Oversight Provide medical and scientific oversight of clinical trials Implement study-specific medical monitoring plans and support medical monitoring activities across clinical trials including ongoing review of patient eligibility, safety data, and protocol adherence Monitor patient safety by reviewing adverse events, laboratory results, and emerging data. Provide real-time medical guidance to investigators during trial conduct, including assessment of complex or unexpected clinical scenarios Participate in and contribute to Data Monitoring Committees, adjudication committees, and safety review meetings as required Data Quality & Integrity, Enrollment and Retention Support case report form design and modification to ensure optimal data capture, scientific rigor, and operational feasibility Direct ongoing review of clinical trial data, including query resolution, to ensure completeness, accuracy, and consistency. Partner with Data Management and Biostatistics to develop high-quality data review plans. Ensure that study databases are clean, audit-ready, and meet standards for regulatory filings. Work with clinical operation and site investigators to proactively identify and address enrollment challenges, ensuring recruitment goals are met Develop, maintain and strengthen investigator and investigator site relationships at specific study sites. Implement strategies to support patient enrollment and retention, including improving site engagement, participant experience, and adherence to study procedures Cross-Functional & External Collaboration Provide leadership to cross-functional project teams, partnering with clinical operations, biometrics, regulatory affairs, biomarkers, clinical pharmacology, and medical writing to deliver on study objectives. Establish and maintain strong external collaborations with investigators, academic partners, CROs, and other clinical trial stakeholders to ensure successful study execution. Working collaboratively within clinical development team performing assignments/tasks as requested Represent Biogen at global scientific conferences, investigator meetings, and advisory boards. Support preparation and presentation of clinical data to health authorities, including FDA and EMA. Strategic Impact Anticipate scientific and operational challenges, proposing innovative solutions to advance program timelines and deliverables. Contribute to overall portfolio strategy by integrating emerging scientific insights and competitive intelligence. Requirements Advanced scientific degree required (MD, PhD, PharmD, or equivalent) 6+ years of clinical development experience in the biotechnology or pharmaceutical industry or equivalent, preferably in organ transplantation Ability to survey and interpret scientific literature related to assigned projects Strong interpersonal skills and ability to collaborate across internal teams and with external clinical partners. Strong analytical skills coupled with excellent oral and written communication skills to present findings and relevant data with the ability to educate and influence senior stakeholders and external experts. Strong organizational skills and ability to thrive in a fast-paced environment while prioritizing and responding to changing business needs Willingness to travel domestically and internationally (approximately 30%) #LI-RD8 Job Level: Management Additional Information The base compensation range for this role is: $191,000.00-$278,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the VP, Clinical Development and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio. Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs. Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans. Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials. Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required. Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program. Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation. Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations. Assist with study milestones and study metrics in collaboration with clinical operations. Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines. Qualifications Primary skills and knowledge required include, but are not limited to the following: A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required. Successful work experience in a matrix team environment with cross functional teams is required. Independent decision-making and analytical skills are required. Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $154,500.00/Yr. Max USD $249,947.00/Yr.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects' data in these studies. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs. Essential Job Functions and Responsibilities: These may include but are not limited to: Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings. Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations. Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) to discussion with clinical team. Perform regular trend analysis in ongoing clinical trials. Lead periodic Medical Review meetings. Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings. Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions. Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents. Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans. Support Clinical Operations, CROs, and site staff on study protocol related questions Support preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates. Participate in research site identification and relationship building with CROs in this space. Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions). Other duties as assigned. Education and Experience: Required: MD, Ph.D., Pharm. D., MPH (Master of Public Health), MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company. Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.). Great analytical skills and a passion for “search and find” among complex data generated in clinical studies. Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization. Ability to thrive and flourish in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions. Ability to inspire and earn respect from the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team Ethical, with the highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders. Desire to develop personal and communication skills through several complex tasks and challenges. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $144,000 - $180,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

SummaryAre you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). Support adoption of new technology or clinical applications through advocacy and evidence. Participate in customer presentations regarding use of Interventional products for institution research purposes. Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. Grow technology leadership mindshare through joint scientific presentations and publications. Install/upgrade research equipment and software & prototypes Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. Study new technology concepts and leverage expertise to move initiatives forward. Note: No sponsorship available for this role now or in the future to work in the United States.. Qualifications PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. 3+ years of experience in Interventional healthcare industry or research. Knowledge of Interventional procedures, anatomies, clinical practice. Excellent written and verbal communication skills. Excellent customer relationship management and collaboration skills. Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Quality, Compliance, and Continuous Improvement focus Desired Characteristics 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. #LI-BR3 #LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The Director of Clinical Science will lead the pre-commercial and key aspects of post-commercial Global Clinical Science team at Dexcom. As a Director of Clinical Science, you will leverage your scientific, medical device, and therapeutic expertise along with executive management skills to drive the global pre-commercial clinical strategy. Your team will lead the development, design, analysis and reporting of Dexcom's clinical studies to meet the labeling, claims, and global regulatory needs of the business. Your team will be responsible for interactions with regulatory agencies as needed and will use your scientific, engineering and medical knowledge to provide directives to teams and study sites as needed. Where you come in: Provide leadership and long-term vision to the Global Clinical Science team to meet the business objectives. Provide input on best practices in clinical research to develop CGM products in a regulated environment inclusive of gold standard endpoints and outcome measures, scientific/ clinical evaluations, study instruments, questionnaires, and relevant standards for evaluating medical devices Informs clinical evaluation (plans and reports), clinical trial protocols, protocol amendments, and scientific publications. Facilitates communication between Commercial, Marketing, R&D, Clinical Program Management, Regulatory & Scientific Affairs, Medical Writing, Product Development, Quality Assurance/Compliance, Medical Affairs, and external CROs. Conduct team meetings and present regular updates to senior staff. Participates in clinical study or clinical evaluation timelines, and budgets Examine data sets and determine the best end-to-end analysis plan to address key scientific questions Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature and staying abreast of current clinical practice. What makes you successful: You will have a PhD, MD, and/or equivalent in endocrinology, metabolic disease or related field with extensive clinical research experience in medical devices. Excellent communication and interpersonal skills. Ability to simplify complex concepts and communicate these to non-clinical team members Expertise in medical writing, including authoring and leading clinical evidence reports, clinical study reports, and other reports needed for regulatory filings and meetings, in the US and globally Optional but nice to have: Advanced Programming Skills (Python, R, SPSS, SAS, MatLab, Etc) and demonstrated advanced statistical analysis experience Experience in the European market Ability to work in a matrixed organization What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: 15+ years of industry experience Typically requires a Bachelor's degree with 9+ years of successful management experience in relevant industry Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $199,600.00 - $332,600.00

Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Responsibilities** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). + Support adoption of new technology or clinical applications through advocacy and evidence. + Participate in customer presentations regarding use of Interventional products for institution research purposes. + Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. + Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. + Grow technology leadership mindshare through joint scientific presentations and publications. + Install/upgrade research equipment and software & prototypes + Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures + Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. + Study new technology concepts and leverage expertise to move initiatives forward. Note: + No sponsorship available for this role now or in the future to work in the United States.. **Qualifications** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. + 3+ years of experience in Interventional healthcare industry or research. + Knowledge of Interventional procedures, anatomies, clinical practice. + Excellent written and verbal communication skills. + Excellent customer relationship management and collaboration skills. + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( + Quality, Compliance, and Continuous Improvement focus **Desired Characteristics** + 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. \#LI-BR3 \#LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. **Additional Information** GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** No

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Develop, coordinate, and implement clinical research studies at the organization's facilities, ensuring adherence to study protocols and timelines * Collaborate with the principal investigator to design study protocols and ensure scientific integrity * Liaise between research subjects, client teams, investigators, and clinic operations teams to facilitate smooth communication and coordination * Plan logistics and resource usage for clinical trials, including scheduling, staffing, and equipment needs * Track study progress in alignment with project milestones, client deliverables, and budget, and provide regular updates to stakeholders * Ensure compliance with applicable regulations globally and by region, including Good Clinical Practice (GCP) guidelines * Supervise experienced support employees and/or entry-level individual contributors, planning, prioritizing, and directing their tasks to ensure efficient workflow and high-quality output * Deliver operational results that have a moderate impact on the immediate achievement of results for the team, contributing to the overall success of the organization * Adapt new procedures, techniques, and tools to improve clinical trial processes and outcomes * Understand basic management approaches such as work scheduling, prioritizing, coaching, and process execution Qualifications: * Broad job knowledge in an operational, administrative, and/or specialized field * Practical knowledge in managing the execution of processes, projects, and tactics within a team * Understanding of the impact of work on related areas Certifications: * Relevant certifications in clinical trial management or related fields Necessary Skills: * Strong leadership and management skills * Excellent communication and collaboration abilities * Ability to plan and prioritize tasks effectively * Proficiency in tracking and reporting study progress * Knowledge of local and regional regulations for clinical trials Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Supervision and/or preparation of study-related documents at the national level, based on reference materials provided by the global project leader. Ensure that all documents comply with local regulations and business procedures. Design and updating of dashboards required for monitoring the study at the national level. Liaison between stakeholders in the trial team, particularly with the preferred vendor for monitoring and administrative support. Lead trial follow-up meetings and prepare and distribute meeting minutes. Monitoring of recruitment progress. Implementation and tracking of site and patient engagement activities. Risk management and implementation of risk mitigation plans. Definition of financial resources (in partnership with contract experts) required for the study. Monitoring of the study budget and justification of any changes or adjustments. Ensuring database lock according to planned timelines. Maintaining strong relationships with study sites, including travel as needed. Oversight of site closures and administrative study close-out.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Project Leadership and Delivery: Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements. Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement. Leads clinical team to ensure quality, timelines and budget management. Accountable for the financial performance of assigned projects Accountable for all project deliverables for assigned projects and/or project regions. Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues. Reporting and Communication: Accountable for maintenance of project information on a variety of databases and systems. Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files. Provides oversight for development and implementation of project plans in accordance with Controlled Documents. Independently prepares, coordinates, and presents project material at internal and external meetings. Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication. Prepares project management reports for clients and management. Implements resource strategies to achieve project goals. Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals. Business Development Participates in bid defense meetings where presented as potential project manager/director. Develops strong relationships with current clients to generate new and/or add-on business for the future. Keeps a current awareness of business unit's and assigned projects' therapeutic environment and drug development trends Management: May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training. May be required to line manage other project management team members and clinical monitoring staff Qualifications Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience. Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures. Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong ability to manage time and work independently. Ability to embrace new technologies. Excellent communication, presentation, interpersonal skills, both written and spoken Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment. Ability to travel as necessary (approximately 25%). At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Role: CTM, Senior Location: US-Remote, East Coast HIGHLY preferred, may look at Central, but will be working EST hours. Travel: This role will be about 80% travel Therapeutic Indication: Neurology or Rare Disease is HIGHLY preferred Summarized Purpose: Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. Key Responsibilities: Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities. Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc…): ensure feasibility report are exhaustive, Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan. Support and ensure that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial. Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate) Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan Validate the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO. Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department. Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines. Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues Knowledge, Skills and Abilities: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). 1+ year of leadership responsibility MUST HAVE previous experience in both on site monitoring & in a CTM role 2+ Years of NEUROLOGY OR RARE DISEASE Experience is HIGHLY preferred Travel: 40-50% Travel; US Travel Previous On Site Monitoring Experience Advanced mentoring/leadership/supervisory skills Excellent clinical trials monitoring skills; ideally remote AND onsite experience Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations(e.g. ICH/GCP, FDA guidelines) Strong organizational and negotiation skills Strong attention to detail Advanced written and oral communication skills Strong knowledge of English language and grammar Demonstrated use of computer to include data entry, archival and retrieval Ability to travel as needed Excellent team player with team building skills Excellent interpersonal and conflict resolution skills Advanced ability to utilize problem-solving techniques applicable to constantly changing environment Solid knowledge of medical/therapeutic areas and medical terminology Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

The Clinical Trial Operations Manager serves to support the design and conduct of operational activities related to planning, implementing, executing, and reporting of multicenter clinical trials in accordance with standard operating procedures, Good Clinical Practice, and local and federal regulations. May provide supervision of multiple Clinical Research Data Specialists that ensure data accuracy across participating clinical research sites. Directs long-range strategic planning for the clinical trial, including the setting of goals and objectives. Ensures that goals and milestones remain on track and develops and implements corrective action plans in an effort to improve performance when needed. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements - 5 years of Clinical Research experience - Multicenter trial management (meaning sponsor facing experience) - Understanding of regulations, IND/IDE trials/regulation exempt trials - Experience with REDCap or similar EDC systems - Single/Central IRB experience - Clinicaltrial.gov registration/reporting experience - Management of sites Academic Medical Center experience

J oin Immatics and shape the future of cancer immunotherapy ; one patient at a time! Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment. Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patients globally. We are seeking a Clinical Trial Manager to support our U.S. Clinical Operations team. The CTM will oversee site management and monitoring activities in compliance with GCP, applicable regulations, and SOPs. FLSA Classification: Salary, Exempt Schedule: 8:00 AM - 5:00 PM; Monday to Friday Reports to: Associate Director, Team Lead Site Operations Location: Fully Remote What You'll Do: As a Clinical Trial Manager, you will play a key role in supporting our finance operations: Collaborate with COL (Clinical Operations Lead) to set targets for clinical monitoring activities, and ensuring the recording of the trial in compliance with project goals Conduct and oversee the clinical trial site feasibility and site selection process Create, maintain and implement trial-specific plans, tools and documents required per SOP (Standard Operating Procedure) (e.g., training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan) Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements Driving the clinical site initiation and greenlight process according to project goals Actively contribute to clinical trial site management and engagement to establish and maintain close site relationships Organize and oversee project-specific training for CRAs (Clinical Research Associate) and clinical trial sites Review trip reports and provide day-to-day expert advice to CRAs Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiates appropriate actions to achieve objectives Conduct Monitoring Oversight Visits ensuring clinical trial site and internal/external CRA (Clinical Research Associate) performance Manage protocol and GCP deviations as Deviation Manager according to SOP Secondary Functions: Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates Required Experience and Education: Min. bachelor's degree, preferably in life science or nursing, or equivalent At least 2 years of on-site monitoring and 2 years of CTM (Clinical Trial Manager) experience in the pharmaceutical or biotechnology industry (including all clinical monitoring visit types) Comprehensive knowledge of ICH-GCP, FDA (Food and Drug Administration) and EMA (European Medicines Agency) (European Medicines Agency) and applicable local regulations and laws Understanding of basic medical oncology terminology and science preferable Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS) Advanced understanding of priorities within own scope with limited interaction with the supervisor Proactively driving quality and efficiency to meet timelines and milestones in own scope Advanced presentation and organizational skills Preferred Experience and Education: Proactively driving company standards, global harmonization and innovation in own scope Advanced reflection on complex process structures and connections Fostering innovation and development in own area of expertise Competencies: Advanced team leader skills and strong team player Proactive attitude with strong sense of responsibility within own scope Positive attitude and willingness to learn and contribute to a team Proficient time management to work efficiently and economically Analytical reasoning and advanced project management skills Strong ability to identify, deeply analyze and communicate problems Proficient verbal and written communication skills in English with high degree of tact and diplomacy Work Environment: This is a sedentary position (at least 50% of the time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs. is expected. Travel required: Willingness to travel up to 50% Physical demands: Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others. Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder. Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). Pushing - Exerting force upon an object so that the object moves away from the object. Pulling - Exerting force upon an object so that the object moves toward the force. Sitting - remaining in a sitting position for at least 50% of the time. Standing/Walking - remain on one's feet in an upright position at a workstation. Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. Work authorization/security clearance requirements: Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. Sick Time Off - 56 hours 12 Paid Holidays 100% Employer-Paid Life Insurance up to at 1x annual salary 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. Partially paid Parental Leave for eligible employees. (3 weeks) Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities Fast paced, high demand collaborative and dynamic environment.

at Triton Digital Canada Inc. We are looking for a Senior R&D Data Scientist to join our Data Science R&D team at Triton Digital. We are using data engineering, data analysis, data science methods and machine learning algorithms to develop innovative solutions for our advertising and audience measurement platforms for podcast and radio. We are analysing vast amounts of data to understand the listeners' interests in specific podcast shows and radio stations, as well as their listening behaviors across media types and time, to improve the way me measure audiences and target them with specific ads. As a Senior R&D Data Scientist, you will report to the Director of Data Science and will work with the other members of the Data Science team as well as other teams at Triton Digital (including big data developers, POs, PMs) to develop and implement data driven innovative solutions into our advertising and measurement platforms for podcast and radio. Your knowledge and experience allow you to work efficiently from the early, and highly challenging stages of experimentation, all the way to obtaining full-scale data science products ready to be implemented in production through cross-functional collaboration. You will work in an Agile environment adapted to suit the needs of R&D work. You will have the opportunity to work in an industry where creating pioneering solutions to address business challenges will be a part of your daily routine. In our ever-evolving industry, every project requires a collaborative and customized approach that can be transparently validated through extensive exploratory data analysis techniques and easily explained to technical and non-technical stakeholders. Therefore, if you are someone who likes to roll up their sleeves and do the work that needs to be done, who is a good communicator, an enthusiastic team player, who likes to think outside the box and embraces a good challenge this position is for you. Qualifications Minimum education requirement: BSc or MSc in computer science or a STEM field with courses in statistical analysis or other advanced data analysis disciplines. Minimum 5 years of work experience in a business environment using Python, PySpark or Scala, with a minimum of 3 years worked as a main contributor to create, validate and help implement data-driven solutions in PySpark or Scala, where you used advanced data aggregation techniques, statistical methods and ML algorithms. Proven track record of using judgment and decision skills to interpret results, to communicate, and to carry out R&D data science work in a result-driven manner. Proven track record of using exploratory data analysis to understand the input data and the results, and to investigate problems to find the causes and create solutions. Ability to work under pressure, learn continuously and pivot to correct the course of the R&D data science work. Ability to focus on the problem and use creative approaches efficiently from the early stages of a project when there are more unknowns than knowns. Ability to work both independently and collaboratively within the Data Science team and with cross-functional teams. Strong communication and time management skills. Responsibilities Collaborate within the team and cross-functionally to help define the project stages and help select the best approaches at each stage. Collaborate within the team to form hypothesis and plan the experimental work at each project stage. Test and compare different methods and algorithms during the experimental project phases. Produce high quality code in PySpark that is easily reviewed by others and easily incorporated into the project's data processing pipeline. Produce methodologies that lead to explainable results. Select the most appropriate R&D methodology for solving the business problem at hand, given that black box algorithms might not be suitable most of the time. Perform extensive data analyses on the input data at the beginning of a project to understand its issues, the value of the information that can be extracted from it, as well as its applicability to solve the problem at hand. Innovate to create and validate variables and use them as input data to train machine learning models, create custom logic rules, or a combination of both. Perform extensive data analyses on results throughout the course of a project to validate them, or to debug inaccuracies and create solutions to address them. Iterate quickly by taking decisions based on results to validate or adjust the course of action for the subsequent analysis steps. Prepare results dashboards and presentation materials to explain work progress and outcomes to decision makers, project stakeholders, and during sprint reviews or team meetings. We work with data that presents us with multiple interesting challenges and interesting problems. You will maintain a strong focus on the work priority to solve the problem at hand. Document methodologies and results in systems such as Confluence and Jira.

Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role Vitalief is seeking a highly organized and detail-oriented Mid-Level Project Manager to provide operational oversight and coordination for our client's Pediatric Acute Leukemia clinical trials. This full-time, fully benefited role serves as the primary liaison between the pharmaceutical clinical research team and CROs, ensuring trials are executed efficiently, on budget, and in compliance with regulatory standards. The Project Manager bridges scientific and operational aspects of clinical research, leading cross-functional teams to deliver high-quality studies evaluating the safety and efficacy of pharmaceuticals. WHY VITALIEF? Contribute to advancing scientific discoveries that improve patient lives. PEOPLE FIRST culture with opportunities for growth and innovation. Competitive benefits include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Salary Range: $70,000 to $80,000 (commensurate with experience). Work Location: 100% Remote (seeking only candidates that live in the EST Zone). KEY RESPONSIBILITIES Trial Planning and Initiation Support bid strategies and contract discussions with CROs, including site selection and patient enrollment. Review and finalize trial protocols and related documents. Build project plans, timelines, and vendor assessments. Establish and maintain collaborative relationships with sponsors, CROs, vendors, investigators, and site staff. Trial Execution and Management Monitor study activities for compliance with protocols and regulatory requirements. Identify potential delays or out-of-scope work and implement mitigations. Manage study risks and escalate issues to leadership as needed. Oversee study documentation, including case report forms, drug records, and regulatory filings. Motivate team members and investigators to achieve trial objectives. Stakeholder Management Maintain regular communication with sponsors and internal teams. Conduct status meetings and provide updates to leadership and stakeholders. Develop realistic budgets and timelines. Quality and Compliance Ensure audit readiness and compliance with ICH/GCP, FDA, IRB/IEC, and SOP requirements. Review monitoring reports and support development of study materials, processes, and committees. Anticipate and mitigate project risks. QUALIFICATIONS Education and Experience Bachelor's degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred. 5 or more years of clinical research experience, including oversight of multicenter or complex studies; oncology experience highly preferred. 2 or more years of experience in a clinical trials oversight capacity as a project manager, ideally working for a sponsor or a CRO. Project management certification (CCPM or PMP) preferred. Knowledge of clinical trial practices and project management principles. Strong organizational, communication, and interpersonal skills. Ability to manage multiple projects, deadlines, and budgets effectively. Proven leadership and collaboration skills in multi-level team settings. Problem-solving and decision-making abilities in fast-paced, dynamic environments. PHYSICAL DEMANDS: Prolonged periods sitting working on a computer, standing, walking, visual perception, talking and hearing. Lifting up to 20lbs.

The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.