Clinical trials management jobs in Sunnyvale, CaliforniaCreate job alerts

Senior Medical Science Liaison – Rare Disease We are seeking a highly skilled Medical Science Liaison to join our team and support the advancement of therapies in rare and complex conditions. This field-based role will serve as a trusted scientific resource for healthcare professionals, providing accurate and timely medical information, supporting research initiatives, and gathering insights to guide strategic priorities. Key Responsibilities • Build and maintain strong relationships with healthcare professionals and key opinion leaders., • Communicate complex scientific and clinical concepts clearly and effectively., • Support ongoing clinical and medical initiatives, including trials and post-marketing activities., • Represent the organization at relevant scientific meetings and conferences., • Advanced degree (MD, PharmD, PhD, NP, or RN)., • Minimum 5 years of MSL experience, ideally within rare disease, neurology, or genetics., • Strong communication, relationship-building, and project management skills., • Competitive compensation and benefits., • Flexible PTO and work structure., • Opportunity to make a meaningful impact in the rare disease community. Interested in hearing more - 📨 ☎️ 786 432 6826

About Power At Power, we believe every patient should have easy access to clinical trials as a care option. Our platform connects patients to research opportunities quickly, transparently, and compassionately — helping sponsors and sites accelerate enrollment while improving diversity and retention. We’re growing fast and looking for a Director of Clinical Operations to lead the team that works directly with sponsors and sites to ensure recruitment success. This is a high-impact role where you'll be the bridge between our technology, our customers, and the patients we serve. What You’ll Do • Lead and grow the Clinical Operations team responsible for executing patient recruitment programs for Phase 2/3 interventional studies across multiple therapeutic areas., • Serve as the primary strategic partner to sponsors and sites, ensuring alignment on goals, timelines, and quality standards., • Oversee the design, launch, and optimization of recruitment campaigns, ensuring targets for enrollment, diversity, and site engagement are met or exceeded., • Develop operational playbooks and processes to scale quality, compliance, and security without sacrificing patient experience., • Partner cross-functionally with Product, Data, and Marketing teams to ensure continuous improvement in recruitment performance., • Monitor KPIs, budgets, and timelines to proactively address risks and remove roadblocks., • Represent the voice of the customer internally, advocating for site and sponsor needs in product roadmap discussions. What We’re Looking For • 6+ years of experience in clinical operations, clinical trial management, or patient recruitment (biotech, pharma, CRO, or site network)., • Proven track record of leading high-performing teams in a fast-paced, customer-facing environment., • Analytical rigor: you aren't afraid of crunching data for your own insights, creating your own dashboards, or cracking open a SQL query, • Deep understanding of site workflows, sponsor priorities, and recruitment challenges in clinical trials., • Strong operational mindset — able to design scalable systems while maintaining attention to detail., • Exceptional communication skills and a consultative approach to customer relationships., • Comfort navigating ambiguity and thriving in a high-growth startup environment. Why You’ll Love Working Here • Mission-driven culture focused on making clinical trials more accessible for everyone., • High-growth environment with opportunities to shape the company’s future., • Competitive compensation, equity, and benefits. If this sounds like your kind of adventure, please email with a quick not about something you've built that you're proud of

Our client, a leader in the medical device industry, is looking for a Regional Sales Manager to spearhead growth across Northern California and Reno, NV. If you’re a proven sales leader with experience in acute care medical device sales, this is your opportunity to step into a high-impact role with an established market leader! 💼 What You’ll Be Driving: 🔹 Sales leadership across Vascular, Urology, Skin Health, and Respiratory specialties 🔹 Business development within IDNs and hospital systems 🔹 Team growth through mentorship, training, and development 🔹 Clinical support for reps in trials, in-services, and executive-level hospital engagement 💰 Compensation & Perks: 💲 Competitive six-figure base salary + performance bonus 📈 Total compensation potential $220K–$320K 🚗 Car allowance + travel reimbursement ✅ Full benefits package ✈️ Travel required (50–70% of the time) 📋 What We’re Looking For: ✔ 2–3+ years of sales management experience in acute care medical device sales (preferred) ✔ Track record of quota-carrying success as a rep ✔ Experience with IDN business development and clinical program strategy ✔ Skilled in building, mentoring, and motivating teams ✔ Strong presence with executive-level hospital decision makers ✔ Ability to thrive in a fast-paced, field-based leadership role 📍 Where You’ll Be Based: • Must live in the San Francisco Bay Area (SF to San Jose) or the Sacramento metro area, • Territory covers Northern California + Reno, NV If you’re a proven sales leader ready to take your career to the next level, we’d love to hear from you! 📩 Send your resume to or apply today!

Do you have medical device experience? Are you interested in neuromodulation? Neuspera Medical is looking for a contract Field Clinical Engineer for the WEST COAST. SNAPSHOT Base Pay: $150.00 hourly Employment Type: Contract/Consulting Job Type: Clinical Education: 4 Year Engineering or Life Science Degree (preferably M.S. Engineering) Experience: >12 years Manages Others: No Industry: Medical Devices Required Travel: Up to 70% - must live on WEST COAST with easy airport access Location: Remote or hybrid About Neuspera Medical, Inc. Neuspera Medical, Inc. is an exciting early-stage medical device company with a uniquely positioned neuromodulation technology platform, headquartered in San Jose, CA. Neuspera is committed to developing implantable medical device technology that will improve the lives of patients battling chronic illness. With the first intended indication for use as Urinary Urgency Incontinence (UUI), the platform technology is ultimately designed to deliver targeted bioelectronic medicine for a variety of conditions. Neuspera’s minimally invasive implants with external wearable transmitters offer the possibility for therapies to reach deeper, harder to access anatomical locations in the body. WHY NEUSPERA? Take the next step in your career and join Neuspera today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of accountability, respect, tenacity, results, and integrity are embedded in everything we do. No matter what your role may be, Neuspera strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success. PRIMARY FUNCTION Neuspera Medical is seeking a contract Field Clinical Engineer with experience supporting and managing medical device trials at research sites. The qualified consultant will be responsible for clinical trial execution and site management. This will be done by developing and leveraging positive relationships with clinical site personnel including physicians, nurses, and clinical research specialists. Duties include site selection, protocol, and product training, implant support, follow-up support, and site management. The goals of this position are to drive patient recruitment, ensure protocol and data compliance, and provide technical support for clinical procedures. JOB DUTIES Conduct Field Clinical Research • Support site selection and activation process, • Deliver protocol, product, and procedure training at sites, • Provide technical implant and follow-up procedure support, • Ensure protocol compliance and data collection integrity, • Manage site performance against enrollment and data quality targets, • Serve as a liaison between company and physician investigators, • Work with R&D to develop next-generation technology and improvements to existing technology, • Target leaders in the field, and then establish and expand collaborative ties between Neuspera Medical and these physicians, • Contribute to a goal-oriented, collaborative & productive work environment, • Acts independently to determine methods and procedures on new or special assignments. May supervise the activities of others The ideal consultant will have experience in all the above areas with an implantable medical device application background, and be familiar with working in hospitals and clinics. External relationships include physicians, clinic staff, hospital staff, and research subjects. JOB REQUIREMENTS Qualifications and Experience: • Minimum - 4-year Bachelor of Science or Engineering with > 12 years experience, or Master’s degree in Engineering or Medical Science, • Preferred - Master’s degree in Engineering or Medical Science with > 12 years of experience, • Minimum - 12 years of experience in a technical or medical field, • Preferred - 12 years of field experience supporting active implantable devices, • Human physiology, physician and hospital practices, engineering, basic computer skills, • Must be able to observe live surgical procedures for purposes of documentation and training, • Must be able to communicate with physicians, internal staff, and patients during surgical procedures, i.e., in a noisy environment, in presence of sterile field, and with limited visibility, • Possess excellent verbal and written communication skills, • Foster work culture of:, • Diversity and inclusion, • Honesty and integrity, • Accountability and teamwork, • Proactive communication focused on results that is based on facts and is respectful Compensation: $150.00 hourly contract/consulting Work Environment: • Office or home based, • Up to 70% travel to hospitals or physician clinics for intermittent periods WEST COAST

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic. Summary Fortvita is seeking a dynamic and experienced Director of Clinical Operations to managing CRO’s and other external vendors, collaborating with cross-functional teams, ensuring study strategy is incorporated into the execution of each study, and that studies are executed on-time, on-budget and in compliance with FDA, EMA & ICH guidelines, SOPs, local regulations. This position requires a high-performing contributor with strong business acumen and leadership skills. This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. The annual base salary for this position ranges from $180,000 to $240,000. This is a hybrid onsite position located in Palo Alto, CA. The ideal candidate will possess a strong background in Clinical Operations and be able to collaborate with cross-functional teams and make strategic decisions. This role is a hybrid model. Responsibilities • Responsible for global clinical trial execution in compliance with ICH/GCP, SOP, regulatory, global and local guidelines., • Participate in the CRO selection process and negotiate master service agreements, scope of work contracts, change orders, etc., • Proactively manage trial start up activities in collaboration with CRO, including feasibility, country/site selection, site contract and budget negotiation, database and lab setup, study plans, training requirements, etc., • Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support regulatory submissions., • Manage CRO and other external partners and collaborate with internal cross functional teams to ensure operational delivery of the assigned clinical trials., • Plan and implement quality checks for multiple clinical trials (e.g., establish and review key performance indicators, metrics, and progress reports, identify barriers to timely and successful trial execution)., • Provide clinical operational input to protocol, ICF, safety and other relevant clinical trial key documents and plans., • Drive and support the development of work instructions and SOPs; contribute to Clinical Operations functional initiatives for role clarity and institution of best practices., • Support the manager to lead clinical operation activities including feasibility, country selection, regulatory and ethic submissions, site startup, operational input to the study design, risk-based quality management., • Prepare clinical trial documents, e.g., project plans, communication plans, clinical trial management plan, site selection, SIV, patient recruitment and retention plan, etc., • Effectively communicate regular clinical trial updates to management on clinical trial progress, performance, risks and mitigation strategies., • All other duties as assigned Qualifications Education: • Bachelor of Science or equivalent degree, required., • Master of Science/Advanced degree preferred. Experience: 10+ years of increasing leadership responsibilities in clinical operations in a pharmaceutical, biotech or CRO company • In-depth knowledge of clinical operations and pharmaceutical drug development process in a pharmaceutical or biotech company in the Autoimmune Therapeutic area, preferred., • Proven ability to lead a team, supervise CRO, and collaborate with cross-functional teams to deliver global clinical trials with high quality, within budget and on-time., • Thorough understanding of FDA, EMA, and HIPPAA clinical research regulatory requirements, good clinical practices, project management and data handling., • Excellent written and verbal communication skills., • Ability to work cross-functionally in a fast-paced, collaborative environment., • Strong attention to detail and problem-solving skills. Compensation and Benefits Include: • Competitive base salary, bonus, and equity for all employees, • Salary Range: $180,000- $240,000. This reflects the company’s pay scale for the role. Actual compensation may vary depending on factors such as location, skills, experience, and performance., • 401(k) retirement plan with employer matching contributions, • Comprehensive medical, dental, and vision insurance, • Generous paid time off policy, including company holidays and floating holidays Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited. We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees. Additional Legal Disclaimers Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs. Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at . We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

Job Description: No 3rd party corp candidates On-Site - Candidates must be local to Palo Alto We are seeking an experienced and strategic Senior Biostatistician to lead biostatistical support across our clinical development programs and regulatory submissions. This role will provide scientific and operational oversight across all phases of clinical trials, ensuring rigorous statistical methodology, data integrity, and regulatory compliance. The ideal candidate is both technically strong and a collaborative leader, with a proven track record of guiding cross-functional teams through global regulatory engagements (e.g., FDA, EMA). Key Responsibilities • Provide statistical leadership across clinical development programs, including study design, protocol development, SAP creation, and analysis planning., • Oversee statistical deliverables for clinical trials from early phase through late-stage development and regulatory submission., • Partner with Clinical, Regulatory, Data Management, and Medical Writing teams to ensure statistically sound study design and high-quality deliverables., • Lead the development and review of key documents, including statistical analysis plans, clinical study reports, and regulatory filings (e.g., NDA, BLA, MAA)., • Represent biostatistics in interactions with regulatory agencies, including preparing responses and meeting participation., • Manage external CROs/consultants to ensure on-time, high-quality statistical support and deliverables., • Drive process improvements, innovation, and adoption of best practices in statistical analysis and data visualization., • PhD or Master's in Biostatistics, Statistics, or a related quantitative field., • 10+ years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry, including expertise in late-phase clinical trials and regulatory submissions., • Proven experience leading teams and managing complex clinical development programs., • Strong knowledge of statistical methods for clinical trials, regulatory guidelines, and CDISC standards (SDTM, ADaM)., • Proficiency in statistical software (e.g., SAS, R)., • Excellent communication, leadership, and project management skills., • Experience with global regulatory interactions and submissions preferred. $110-$115 hourly W2 / $135-$140 hourly 1099, commensurate with experience

Job Title : Deputy Director Job Summary : Work Schedule: Onsite requirements; 2 days a week This is a highly critical position and requires an in-depth set of broadly developed knowledge, experience and competency in risk mitigation, contracts, stakeholder education, and consultation. The position manages complex issues with minimum or no precedent where analysis of situations or data requires an in-depth evaluation of variable factors. The position serves as subject matter expert to Deputy Chief Campus Counsel, AVC Research, and AVC Chief Procurement Officer to ensure a high level of acumen and experience to develop and implement risk mitigation strategies and manage complex contracts and affiliation agreements. Uses advanced enterprise risk management concepts, contracts knowledge, and organization objectives to resolve highly complex issues with organization-wide impact. Exercises judgment in selecting methods, strategies, and evaluation criteria for obtaining optimal results. Partners with other risk officers and analysts to implement best practices. Is considered a subject matter expert and often recognized as an industry expert by external contacts. The consequence of error in analysis, recommendations, and implementation is extremely high. The level of exposure to the University has the potential for significant financial, reputational, and human impact. This position also serves as a Center of Excellence for the RAIS department. As such, the position educates stakeholders; develops resources and reference materials on risk-related topics; conducts research on and evaluates new or emerging risk areas; monitors success criteria and tracks program metrics; supports implementation of policies, standards and regulations. In addition, this position provides leadership support when the Executive Director is not present. It represents the Executive Director’s role on assigned committees and acts on behalf of the Executive Director as needed. The position serves as a direct resource to the Senior Vice Chancellor in the absence of the Executive Director as needed. The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. The salary range for this position is $118,300 - $268,900 (Annual Rate). To learn more about the benefits of working at UCSF, including total compensation, please visit: ___ Department Name :FIN Risk Mgmt and Insurance Department Description : The Risk Advisory & Insurance Services (RAIS) department is responsible for strategies, systems, programs, and policies to identify and mitigate risk in order to protect UCSF’s human, financial and physical assets. The department educates and advises UCSF decision-makers on potential risks and mitigation strategies relating to general liability, employment practices liability, construction, property non-construction, auto liability, cyber and privacy, travel, foreign liability, clinical trials, clinical research subject injury liability. The department also procures construction and clinical trials insurance services for UCSF Campus and UCSF Health to protect organizational assets. RAIS is part of the UCSF Finance organization. Required Qualifications : • Bachelors degree, preferably with a specialization in business and/or contract law and/or equivalent education/experience., • 10-15 years progressive relevant experience, • Enterprise Risk Management professional certification (ERMP), • Expert and specialized knowledge in the following areas: risk management; insurance; forecasting and analysis; accounting; risk modeling process; knowledge of common organization-specific computer application programs; knowledge of organizational processes and procedures; understanding of organizational rules and regulations., • Expert interpersonal skills, customer service orientation, active listening skills and highly effective team leadership skills., • Highly developed ability to concisely present complex risk findings and make recommendations verbally and in writing., • Highly developed ability to use critical thinking and analytical skills to solve problems., • Advanced ability to develop course materials and deliver content effectively to diverse population., • In-depth knowledge of risk management. Preferred Qualifications : License/Certification : Employee Class : Career

Position: Biostatistics / Data Science Lead (Can be remote) Overview: Our client seeking a hands-on Biostatistics/Data Science leader to drive the design and implementation of scalable, compliant, and efficient statistical workflows supporting Gilead’s drug development programs. This role combines technical excellence in R and data engineering with leadership in cross-functional collaboration, reproducibility, and innovation within regulated environments. Key Responsibilities: • Lead the development of R-based statistical tools, pipelines, and reproducible workflows to support clinical trial analysis and reporting., • Collaborate with statisticians to translate complex methodologies into robust, validated R code for simulations, adaptive designs, and advanced analyses., • Oversee R package development, GitHub workflows, and CI/CD pipelines, ensuring code integrity, documentation, and compliance., • Define solution architectures integrating open-source tools and cloud-based infrastructures for large-scale, compliant data management., • Partner with IT, data engineering, and business teams to streamline processes, enhance automation, and maintain data governance standards., • Guide standardization and best practices for code development, validation, and regulatory readiness., • PhD in Statistics, Biostatistics, Computer Science, or related field with 5+ years of experience (MS with 10+, BS with 12+)., • Deep expertise in R programming, R package development, and statistical implementation in clinical trials., • Proven experience with GitHub version control, CI/CD, and collaborative coding workflows., • Strong background in data engineering, automation, and reproducibility in a regulated (pharma/life sciences) environment., • Familiarity with Pharmaverse packages and open-source software development practices., • Experience with AWS/cloud data pipelines, distributed computing, and additional programming languages (Python, SQL)., • Demonstrated ability to bridge between statisticians, data scientists, and engineers.

Description Specialization: Hematology and Medical Oncology Job Summary: Job Description: We are seeking an experienced BC/BE Hematologist Oncologist to join our extensive, well-established, physician-led and managed group practice in the Bay Area, California. Our team has provided exceptional care to patients for nearly 50 years. Nestled in the picturesque surroundings of Monterey, CA, we are not just a healthcare institution it's a dynamic community of healthcare professionals committed to providing unparalleled cancer care. With state-of-the-art facilities and a patient-centric approach, we offer a range of cutting-edge treatments and therapies to ensure the best possible outcomes. Nutrition counseling, facilitating mind-body wellness, encouraging exercise and fitness, devising survivorship plans, and harnessing palliative therapies all contribute to the total care plan. We are a national partnership of leading independent community oncology practices working together to improve the lives of everyone living with cancer with a physician-led, data-driven, technology-powered, and patient-centric model. Our partner practices have shared technology platforms that foster communication, data sharing, and clinical excellence across the network. The non-exclusive clinical trial site management subsidiary delivers complex, multi-center clinical trials to affiliated practices. Qualified Candidates: • Must be fellowship trained in hematology/oncology, • Ideal Candidate: Board-Certified, experienced physician preferred with focus on Breast Malignancies, • Must be able to attain a California state medical license, • Excellent communication skills Incentive/Benefits Package:, • 4 Day Direct Patient Care Work-Week, • Highly Competitive Compensation Models, including Productivity/Quality Incentives, • CME Reimbursement, • Comprehensive Medical/Dental Benefits, • Retirement Savings Plan, • Malpractice Coverage, • Generous Paid Time Off, • Opportunity for Career Growth, • Ability to Enroll Patients in Clinical Trials, • Ability to Participate and Present Research at Conferences, • Chance to Care for Patients in the Comfort of their Communities, • Become part of Physician-Led Organizations that Supports Work/Life Balance County-designated STEMI Receiving Center with a newly expanded and renovated Emergency Department and ambulance bay, designed for safe, efficient, and timely care. Advanced Cardiovascular and Electrophysiology Services with state-of-the-art cath labs, diagnostic and interventional offerings, and cutting-edge technology including Impella, IFR, FFR, Watchman, and minimally invasive valve and bypass surgery. Innovative Robotics Program featuring 2 da Vinci s, Mako, ROSA, Mazor, and ExcelsiusGPS for procedures in orthopedics, spine, bariatrics, general surgery, gynecology, and urology. Award-winning Orthopedics and Spine Program with a dedicated inpatient unit, Joint Commission Gold Seal of Approval for Hip & Knee Replacement, and Blue Distinction Center designation by Anthem Blue Cross. Pediatric Surgery Specialization and Level III NICU with CCS certification, 24/7 OB hospitalists, anesthesia, maternal-fetal medicine, neonatology, and lactation support. Comprehensive Women s & Children s Services including Level IV Maternal Designation, Child Life Specialists, perinatal navigators, and Blue Distinction Maternity Care. Full-Service Oncology Program with ACoS Accreditation as a Comprehensive Community Cancer Center, five-time ACoS Outstanding Achievement Award recipient, clinical trials, outpatient infusion, radiation oncology (ACR accredited), nurse navigation, survivorship support, and Ion Robotic Bronchoscopy. Comprehensive Behavioral Health Services for adults and older adults, offering inpatient, outpatient, partial hospitalization, intensive outpatient, and 12-step recovery programs. Breast Health Services with NAPBC Accreditation and ACR Accreditation in mammography, stereotactic biopsy, MRI, and ultrasound; includes 3D mammography, breast surgeons, radiologists, nurse navigation, and a high-risk program. CARF-Accredited Inpatient Rehabilitation with special accreditation for stroke care, offering physical, occupational, and speech therapy, plus wound care and cardiac rehab. Surgical Weight Loss Program with MBSAQIP Accreditation, state-of-the-art ORs featuring the latest da Vinci system and Stryker tower. For more information, visit .

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Job Title Principal Clinical Scientist Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career of which you dream., • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year., • An excellent retirement savings plan with high employer contribution, • Tuition reimbursement, the ___ student debt program and ___ education benefit - an affordable and convenient path to getting a bachelor’s degree., • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune., • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position may work out of any of our Vascular Division sites: Santa Clara, CA, Temecula, CA, St. Paul, MN, Westford, MA. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. MAIN RESPONSIBILITIES • Design clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs, medical affairs as well as external stake holders including steering committees, and national principal investigators to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA, and strategic business needs., • Provide scientific and technical direction and feedback. Provide scientific leadership to Cross Functional and Marketing/Commercial Teams to support business priorities and serve as Clinical Science lead on study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information, including pre-submissions to FDA., • Lead the generation of study-related documents and/or contribute content and oversight of such documents, including, clinical study protocols, case report forms, clinical study reports, and informed consent forms., • Critically analyze data and present to internal and external groups including but not limited to clinicians and cross-functional team members., • Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy., • Lead/collaborate on submission of abstracts, presentations, and publications of clinical study data, working with investigator authors and internal teams., • Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area., • Review and critically assess statistical analysis plans., • Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions., • Attend, present at, and lead meetings with FDA and other regulatory bodies., • Contribute to the optimization of internal processes and workflows., • Develop new ideas for both external and internal projects., • Mentor junior team members., • Perform other related duties and responsibilities, on occasion, as assigned. EDUCATION AND EXPERIENCE YOU’LL BRING: Required Qualifications • Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred., • Minimum of 8+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience., • Comprehensive knowledge of a particular technological field., • Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships, • Recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations., • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. Preferred Qualifications • MS Office Suite, highly preferred, • Experience in the medical device industry, highly preferred, • Experience with clinical trials, highly desirable, • Experience in a vascular/cardiovascular fields, a plus Please note that the salary range listed is our full grade range. We usually hire based on the mid-point. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ___ Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ___, on Facebook at ___ and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career you dream of., • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO, • An excellent retirement savings plan with high employer contribution, • Tuition reimbursement, the ___ student debt program and ___ education benefit - an affordable and convenient path to getting a bachelor’s degree., • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune., • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Santa Clara, CA location in the Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The Sr. Research Scientist Provides scientific expertise throughout the development and implementation of clinical studies. Writes/manages clinical trial protocols, protocol amendments, clinical study reports, clinical trial registrations and results postings, clinical study project timelines and scientific publications. Interacts with various study support groups cross-functional teams in order to assist in clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed and will use their scientific and medical knowledge in order to provide strategic communication to staff as well as study sites as directed by your manager. What You’ll Work On • Facilitates development of clinical strategy and trial design by interacting with study PIs, key opinion leaders (KOLs) and collaborating cross functionally with other departments including Global Clinical Operations, Research & Development, Regulatory Affairs, and Biostatistics., • Writes, study protocols, protocol amendments, informed consents, study reports, scientific presentations and papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice., • Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings., • Works collaboratively with R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Marketing and Sales, Senior Management and investigational sites., • Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff., • Creates, manages, or participates in clinical study timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines., • Throughout study, when appropriate, works cross functionally with clinical field teams and data management to identify missing data, uses metrics regularly to ensure data completeness., • May work closely with external groups, such as core laboratories, to assess and interpret data., • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Generate documents to support regulatory submission for product and/or respond to questions from regulatory authorities about existing submission., • Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice., • Participates in and supports audits., • Comprehensive knowledge of a particular technological field., • Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships., • Is recognized as an expert in work group and across functions., • Will perform this job in a quality system environment., • Failure to adequately perform tasks can result in noncompliance with governmental regulations., • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors., • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results., • Has broad knowledge of various technical alternatives and their potential impact on the business. EDUCATION AND EXPERIENCE YOU’LL BRING Required Experience • Bachelor’s degree in related field, • Minimum 8 years experience, • Experience in clinical trials, working in a regulated environment., • Experience in medical and scientific writing., • Comprehensive knowledge of a particular technological field. Preferred Experience • Familiarity with one or more data analysis software (such as Excel, Tableau, Power BI) is highly desirable., • PhD, MD, PharmD or MSN preferred, or BA/BS with an equivalent combination of education and work experience • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ___ Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ___, on Facebook at ___ and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Senior Manager Medical Affairs Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career you dream of., • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year., • An excellent retirement savings plan with a high employer contribution, • Tuition reimbursement, the ___ student debt program, and ___ education benefit - an affordable and convenient path to getting a bachelor’s degree., • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune., • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Santa Clara, CA location in the Structural Heart (SH) Medical Affairs Division. Responsibilities within the Structural Heart Investigator Sponsored Studies (ISS) that includes partnering with Medical Directors to identify strategic areas of interest, cross-functional review of submitted study proposals, and upon approval, manage the studies from initiation to execution and tracking of study milestones. As appropriate, work with investigators and internal cross-functional partners to ensure high-quality studies meeting medical/scientific/business needs. What You’ll Work On:  Database & Reporting • Maintain and update ISS iEnvision database for dashboards and SH performance metrics., • Review training materials for medical accuracy and regulatory compliance. Required Qualifications  Clinical Expertise • 5+ years background in Clinical Operations/Clinical Trials with strong scientific knowledge across Structural Heart products., • Experience managing ISS, grants, and medical events (MABs, symposiums, training sessions, master classes)., • Proven ability to lead and manage cross-functional projects within Medical Affairs., • Effective team player with strong individual problem-solving skills., • Proficient in Microsoft Office Suite, PowerPoint, Project, SmartSheet, and Power BI., • Experienced in creating dashboards and performance metrics. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ___ Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ___, on Facebook at ___, and on Twitter @AbbottNews. The base pay for this position is $128,000.00 – $256,000.00. In specific locations, the pay range may vary from the range posted.

Job DescriptionData Manager Status: Full-time, Exempt Reports to: Sr. Director Clinical Operations About the Role VahatiCor is a medical device startup developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where every team member contributes to advancing solutions that improve patient outcomes. We embrace the urgency of a startup environment while maintaining the highest standards of quality and compliance. Overview We are seeking an experienced Data Manager to lead the design, implementation, and management of clinical data systems that ensure the accuracy, integrity, and usability of our clinical trial data. The ideal candidate is proactive, technically skilled, hands-on, detail-oriented, and thrives in a dynamic setting where rapid execution and adaptability are critical. Key Responsibilities · Develop and maintain comprehensive Data Management Plans (DMPs) for clinical studies. · Design and build Case Report Forms (CRFs) aligned with study protocols. · Implement CRFs within Electronic Data Capture (EDC) system to support site data entry. · Perform ongoing data cleaning and validation activities throughout the trial lifecycle. · Generate and manage data queries; identify and track trends, outliers, and inconsistencies in clinical datasets. · Collaborate cross-functionally with Clinical Operations, Biostatistics, and Regulatory teams to ensure high-quality, compliant data. · Conduct regular data reviews and reconciliation to maintain database integrity. · Support clinical study teams by providing data reports, listings, and metrics as needed. Qualifications · Bachelor’s degree in Life Sciences, Computer Science, or related field. · 5+ years of experience in clinical data management within Class III regulated medical devices with a focus on catheter-based technologies. · Hands-on experience with EDC systems and CRF development. · Strong knowledge of GCP, FDA, and ICH guidelines related to clinical data management. · Demonstrated expertise in data cleaning, query generation, and issue resolution. · Ability to interpret clinical data, identify anomalies, and provide actionable insights. · Experience building or configuring EDC systems from the ground up (preferred). · Familiarity with cardiovascular clinical trials is strongly preferred. · Excellent communication, documentation and organizational skills · Thrives in a fast-paced startup environment. Eligibility Candidates must be legally authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor H-1B visas. Location & Compensation This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package. The anticipated salary range of this position is $125,000 to $170,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.

Job DescriptionDescriptionPrecision Neuroscience is pioneering a brain implant, known as a brain-computer interface (BCI), to restore communication and independence for people with neurological conditions. Our cutting-edge technology is designed to empower people with paralysis to control digital devices—such as computers and smartphones—with their thoughts alone, opening new possibilities for daily life. Precision’s multidisciplinary team brings together leading experts in diverse fields such as neurosurgery, artificial intelligence, machine learning, microfabrication, electrical engineering, and more. We are committed to turning breakthrough scientific advancements into real-world solutions for people affected by conditions such as spinal cord injury, stroke, and ALS. As a Precision employee, you will be joining one of the fastest moving and best-capitalized companies in the emerging field of BCI. Since our founding in 2021, Precision has secured over $155 million in funding, developed and validated our technology, and initiated human trials in collaboration with some of the nation’s top hospitals. We are seeking a Product Manager of Machine Learning to drive the execution of our machine learning initiatives. This individual will partner closely with our ML lead and cross-functional teams to plan, prioritize, and deliver ML-driven features and capabilities. In this role you will own the day-to-day product management of the ML team – breaking down complex initiatives into actionable plans, defining clear requirements and success metrics, and ensuring timely execution of work that supports our clinical programs and next-generation product roadmap. This is a unique opportunity to shape groundbreaking brain–computer interface technology that will directly impact the lives of people living with severe neurological conditions. This position will be based in our Manhattan or Santa Clara office. We are unable to consider remote workers or people not currently based in the United States, with working rights. Key Responsibilities • ML Team Planning & Execution: Own the day-to-day planning and management of the ML team’s work, including backlog generation, refinement, and sprint planning., • Requirements Definition: Collaborate closely with the ML lead and cross-functional stakeholders (clinical, UX, hardware, software, and other PMs) to gather, define, and document detailed ML requirements and success metrics., • Implementation & Acceptance Criteria: Partner with UX research and design to define implementation details and acceptance criteria for ML-driven features, ensuring user-centered outcomes., • Work Breakdown: Break down complex ML initiatives into epics and user stories to drive efficient development cycles., • Clinical Collaboration: Partner with the clinical team to ensure the ML team has the data and patient enrollment necessary for model development and validation. Support IONM and EONM case planning, goal-setting, and learnings capture., • 3+ years of experience in product management, ideally with a strong focus on machine learning or AI-driven products., • Proven experience in Agile development, including sprint planning, backlog management, and epic/story creation., • Solid understanding of machine learning concepts, methodologies, and data pipelines., • Strong track record working with cross-functional teams including ML engineers, data scientists, UX designers, and clinical professionals., • Excellent communication, interpersonal, and presentation skills., • Ability to thrive in a fast-paced, innovative environment., • Experience in healthcare, neuroscience, or a related field is a plus.Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Description Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Medical Director is involved in the design, monitoring, data analysis, and interpretation of the Company’s late-phase clinical trials in endocrinology. As such, the Medical Director is an important and visible member of the clinical development team. The Medical Director position is based in the United States (preferably in Palo Alto, California) and will report to the Vice President, Clinical Science. Key Responsibilities • Contribute to formulation and implementation of the Clinical Development Plan, • Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program, • For clinical trials: design, provide overall oversight, and support site and subject retention, • Serve as a Medical Monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy data, • Provide leadership to teams of medical monitors, • Provide leadership to study teams, • Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members, • Ensure study integrity, and track accumulating safety and efficacy data, • Analyze, evaluate, interpret, and report clinical data, • Anticipate and solve complex drug development problems, • Contribute to regulatory strategy, • Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions, • Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance, • Collaborate with—and serve as a clinical research resource for—cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development, • Contribute to (and may be asked to represent the clinical development department in) corporate strategic and organizational initiatives, • Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company, • Assist in portfolio management and commercial activities as needed, • Complete assigned tasks thoroughly, accurately, and on time Knowledge, Skills and Experience • M.D. degree, • Completion of ACGME-accredited residency and fellowship (strongly preferred), • Physician licensure in at least one state (strongly preferred), • Board-certified (strongly preferred), with specialty in endocrinology highly desired, • At least 5 years of industry experience (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis). Those with less experience may be considered for an Associate Medical Director position., • At least 3 years of experience with clinical trial design and execution, • Strong track record of scientific and clinical inquiry, • Possess excellent communication skills (written and oral), • Learn quickly, follow complex directions under pressure, • Multi-task while remaining organized and attentive to detail, • Lead both directly and by example, • Work hard, be a trustworthy and collaborative team player, • Take initiative and solve complex problems, • Demonstrate sound judgement in terms of handling complex, confidential, and regulated information Travel up to 20% domestically and internationally for scientific meetings. Salary range: $265-295K/year Benefits • 401(k) plan with company match, • Medical, dental, and vision plans, • Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance, • Company-provided short and long-term disability benefits, • Unique offerings of Pet Insurance and Legal Insurance, • Employee Assistance Program, • Employee Discounts, • Professional Development, • Health Saving Account (HSA), • Flexible Spending Accounts, • Various incentive compensation plans, • Accident, Critical Illness, and Hospital Indemnity Insurance, • Mental Health resources, • Paid leave benefits for new parents A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Job DescriptionCompany Description • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices., • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Responsibilities: • Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity., • Conduct on-site supplier assessments as well as QMS audits and address the non-conformities., • Work with suppliers and ISI engineering for the new product introduction to, • Complete part production qualification process ( PPQP), which includes but not limited to delivering on the following deliverables: spFMEA, Special Process Validations, Process capability, MSA, capacity analysis, and FAIR., • Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability., • Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production., • Lead and resolve the supply continuity/ quality issues at suppliers through in depth root cause and corrective actions utilizing SCARs, SCRs (Supplier Change requests) processes., • Monitor supplier performance and initiate improvement activities., • Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgical's requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously., • Develop and use metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity., • Driving change to ISI specifications as necessary by understanding and changing specifications and drawings including driving the ECO process to implementation., • Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs, Supplier Summits, etc., • BS degree in Engineering or equivalent, master's degree preferred., • Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards): Certified Lead auditor preferred but not required., • Practical knowledge of PFMEA's and process validations., • Ability to read and interpret detailed mechanical drawings and communicate technical information., • Excellent problem solving and project management skills., • Excellent written and verbal communication skills including presentations to executive level management., • A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers., • Practical knowledge of part production qualification process., • Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP., • CAD experience with 3D modelling tools is a plus., • Experience in a high-volume medical device company is a plus., • Ability to travel to suppliers on an as needed basis – domestic and international.Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionFocusKPI is seeking a Senior Product Manager to join one of our clients, a high-tech SaaS company. Work Location: Mountain View, CA Duration: 12-month contract with potential to convert depending on candidate's performance (Hybrid role, 4 days/week onsite) Pay Range: $80/hr to $93/hr No C2C resumes are considered Responsibilities: • Create novel and innovative product strategy and product concepts that contribute to a robust product development pipeline, • Collaborate with research, engineering, clinical, data science, and their broader teams with a clear product vision to ensure delivery of products per milestones, • Identify, select and engage with industry partner companies and organizations (including payers, healthcare providers, academic institutions, technology companies) to advance the client’s health-focused research and product development efforts, • Collaborate with the design team to translate complex problems into simple, elegant, and minimal solutions, • Lead the design thinking process for your team—from problem definition to design implementation, • Drive product strategy (define product vision, strategy, roadmap, analytics, and success metrics; collaborate with internal business and strategy teams to strengthen product position), • Drive product development working closely with technical program managers and development leads (market and user research, design, development, validation, and deployment), • Own product requirement document (PRD), user guide, and product performance reporting; be the single point of contact for key stakeholders, including executives, partners, business, strategy, engineering, design, QA, operations, and legal, • Lead product management, including market opportunity and user need identification, product vision & strategy formation, roadmap, product definition & development, business case development, competitive positioning, goal/KPI setting & monitoring, • Product design experience (extensive experience working closely with designers and user researchers to derive consumer insights, create prototypes and mockups to test, refine, validate, and defend new product opportunities), • Healthcare domain knowledge about reimbursement, • Working knowledge of privacy standards for Health data, including HIPAA and other state privacy lawsRequirements:, • Bachelor of Science/Master's in Computer Science or a related technical discipline, or equivalent combination of education, training, and experience, • 5+ years of product management experience (building consumer apps), • Industry background requirement: experience in the health industry or the fitness & wellness industry, • 2+ years of experience in UI/UX Design, designing and shipping products to market, • 1+ years of experience in managing co-innovation and joint development between the tech and healthcare industries, • Experience and ability to lead and manage people and teams based on business needs, • A user-centered and iterative approach to designing software for people, • Experience in designing, developing, and validating digital health products, • Experience in designing and conducting studies of wearable devices or clinical trials with human subjects, both in lab and field setting, • Experience in collaborating on software implementations of algorithms and developing software as a medical device with client and cloud engineers, • Demonstrated business agility and ability to work in a fast-paced, ambiguous, and frequently changing environment while prioritizing and managing multiple sets of responsibilities, • Worked on a health product that drove service revenue, • Working knowledge of care plansTop 3 skills (must have skills):, • Good consumer product management experience (Software product management), • Good Product sense, thinking about user pain points, understanding, and the ability to solve them, • Excellent communication skills No C2C resumes are considered Thank you! FocusKPI Hiring Team Founded in 2010, FocusKPI, Inc. (FocusKPI) is a data science and technology firm specializing in predictive analytics practice and methodologies. FocusKPI is a US company headquartered in Silicon Valley, California, with an East Coast office in Boston, Massachusetts. NOTICE: Please be aware of fraudulent emails regarding job postings, job offers and fake checks. FocusKPI's recruiting team will strictly reach out via @focuskpi.com email domain. If you have received fraudulent emails now or in the past, please report it to . The domain @focuskpijobs.com is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @focuskpijobs.com. Powered by JazzHR CqpAeuYVRz

Job Description Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Senior Manager, Statistical Programming, will be expected to provide timely and strategic programming support to clinical study teams in alignment with project goals. This role combines hands-on programming responsibilities with leadership in study execution and tool development. The successful candidate will serve as the Statistical Programming Lead for one or more clinical trials, taking responsibility for all programming deliverables from study start through regulatory submission. In addition, this person will support the development and maintenance of departmental programming tools, such as standard macros and specification templates of SDTM and ADaM used across clinical studies. This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows. This position is based in Palo Alto, CA or may be remote. Key Responsibilities • Serve as the Statistical Programming Lead for clinical trials, overseeing all programming deliverables from study start to submission., • Represent Statistical Programming in cross-functional study team meetings and contribute to project planning and timelines., • Develop, validate, and maintain SDTM and ADaM datasets, following CDISC standards and study specifications., • Generate or validate tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions., • Support statisticians with planned and ad hoc analyses., • Develop and maintain reusable macros, templates, and specification tools to support consistent and efficient programming practices across studies., • Collaborate with cross-functional teams including Biostatistics, Data Management, and Medical Writing to ensure high-quality deliverables., • Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field with at least 10 years of programming experience in the pharmaceutical or biotech industry; or a Master’s degree with at least 7 years of relevant experience., • Proven experience as a lead programmer for clinical trials and complex technical projects., • Excellent knowledge of CDISC standards, including SDTM and ADaM., • Understanding of the clinical drug development process and regulatory requirements., • Proficiency in SAS programming, including the ability to develop and validate reusable macros., • Familiarity with other programming languages or tools (e.g., R, Python, Git, VB) is a plus., • Experience contributing to departmental tools (e.g., macro libraries, specification templates, or automation tools) is preferred., • Strong verbal and written communication skills, with the ability to collaborate effectively across functions. A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged. Benefits • 401(k) plan with company match, • Medical, dental, and vision plans, • Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance, • Company-provided short and long-term disability benefits, • Unique offerings of Pet Insurance and Legal Insurance, • Employee Assistance Program, • Employee Discounts, • Professional Development, • Health Saving Account (HSA), • Flexible Spending Accounts, • Various incentive compensation plans, • Accident, Critical Illness, and Hospital Indemnity Insurance, • Mental Health resources, • Paid leave benefits for new parents

Job Description Product Manager – Digital Health TeamResponsibilities: • Create novel and innovative product strategy and product concepts that contribute to a robust product development pipeline, • Collaborate with research, engineering, clinical, data science, and our broader teams with a clear product vision to ensure delivery of products per milestones, • Identify, select and engage with industry partner companies and organizations (including payers, healthcare providers, academic institutions, technology companies) to advance our health focused research and product development efforts, • Collaborate with the design team to translate complex problems into simple, elegant and minimal solutions, • Lead the design thinking process for your team—from problem definition to design implementation, • Drive product strategy (define product vision, strategy, roadmap, analytics, and success metrics; collaborate with internal business and strategy teams to strengthen product position), • Drive product development working closely with technical program managers and development leads (market and user research, design, development, validation, and deployment), • Own product requirement document (PRD), user guide, and product performance reporting; be the single point of contact for key stakeholders including executives, partners, business, strategy, engineering, design, QA, operations, and legal, • Lead product management including market opportunity and user need identification, product vision & strategy formation, roadmap, product definition & development, business case development, competitive positioning, goal/KPI setting & monitoring, • Product design experience (extensive experience working closely with designers and user researchers to derive consumer insights, create prototypes and mockups to test, refine, validate and defend new product opportunities), • Healthcare domain knowledge about reimbursement, • Working knowledge of privacy standards for Health data including HIPAA and other state privacy lawsRequired Skills, • 12+ years of product management experience with a minimum of 5+ years in the healthcare industry (consumer and/or enterprise focus), • 3+ years of experience in UI/UX Design, designing and shipping products to market, • 1+ years of experience in managing co-innovation and joint development in between tech and healthcare industries, • Experience and ability to lead and manage people and teams based on business needs, • A user-centered and iterative approach to designing software for people, • Experience of designing, developing and validating digital health products, • Experience in designing and conducting studies of wearable devices or clinical trials with human subjects both in lab and field setting, • Experience in collaborating on software implementations of algorithms and developing software as a medical device with client and cloud engineers, • Demonstrated business agility and ability to work in a fast-paced, ambiguous, and frequently changing environment while prioritizing and managing multiple sets of responsibilities, • Worked on health product that drove service revenue, • Working knowledge of care plans, • Bachelor of Science/Master's in Computer Science or a related technical discipline, or equivalent combination of education, training, and experienceCompensation: $70 - $93.19 per hour ID#: 36335251

Job Description Customer Success Manager – Remote (Full-Time) Location: Remote (US-based preferred) Department: Customer Success / Clinical Trials Reports to: VP of Clinical Trials Company Overview Vivalink is a leader in digital health technology, delivering advanced remote data capture solutions for healthcare and clinical research. Our Biometrics Data Platform integrates FDA-cleared medical-grade wearable sensors, cloud-based data services, machine learning algorithms, and clinician software—empowering global organizations to design and deploy remote patient monitoring (RPM) and decentralized clinical trial (DCT) solutions. We support pharmaceutical companies, CROs, Academia, and healthcare providers with the tools to capture high-quality, real-time physiological data across a wide range of therapeutic areas, including cardiology, neurology, infectious disease, oncology, and rare diseases. Role Summary We are seeking a dynamic, detail-oriented Customer Success Manager (CSM) to join our team and help ensure the success of our growing base of clinical research customers. The CSM will serve as the primary point of contact post-sale, responsible for onboarding, project coordination, troubleshooting, relationship development, account penetration, and long-term retention. You will work closely with cross-functional teams—including Solutions Engineering, Product, Operations, and Sales—to ensure our customers receive an exceptional experience and achieve their desired outcomes. Key Responsibilities * Customer Onboarding & Implementation * Coordinate the onboarding process for new clinical trials and RPM deployments, including technical setup, workflow design, training, and user enablement. * Collaborate with clients to define project goals, success metrics, and timelines. * Account Management & Retention * Serve as the trusted advisor and point of contact for assigned customer accounts and as the liaison between customer and internal teams, such as Product, Sales, Operations and Support. * Monitor ongoing study health and proactively identify issues, ensuring timely resolution. * Drive renewals and expansions by demonstrating value and anticipating customer needs. * Be the voice of the customer within the organization to ensure needs are prioritized. * Cross-Functional Coordination * Work with Product, Sales, Operations and Support teams to escalate and resolve customer concerns and issues quickly and effectively. * Work with finance to support timely collections. * Provide customer feedback to inform roadmap priorities and service improvements. * Performance Monitoring & Reporting * Track device usage, data quality, participant adherence, and other key performance indicators. * Track progress against defined project goals, success metrics, and timelines * Deliver regular reports and business reviews with actionable insights. * Advocacy & Relationship Building * Cultivate strong relationships with clinical operations, data managers, investigators, and study coordinators. * Promote Vivalink’s broader capabilities to drive customer expansion and satisfaction. Qualifications Required: * 5+ years in a Customer Success, Clinical Operations, Project Management, or related client-facing role. * Demonstrates a strong ability to understand, communicate, and create alignment with different stakeholders in the client’s organization * Strong understanding of digital health, clinical trials, and remote patient monitoring * Strong experience working with pharmaceutical, biotech and CRO companies. * Excellent written and verbal communication skills. * Analytical mindset with the ability to interpret data and derive insights. * Comfortable working in a fast-paced, startup-like environment with minimal supervision. * Bachelor's degree in Life Sciences, Healthcare, Business, or related field. Preferred: * Experience with medical devices, wearables, or remote patient monitoring solutions. * Familiarity with clinical trial operations, GCP, ICH guidelines, or regulatory considerations (e.g., HIPAA, 21 CFR Part 11). * Experience with digital tools such as Hubspot, Jira, Slack, or Confluence. * Clinical research certification (e.g., CCRA, CCRC, PMP) is a plus. Why Join Vivalink? * Be at the forefront of remote patient monitoring innovation. * Work with a collaborative, mission-driven team. * Contribute to impactful studies in areas like cardiology, oncology, and infectious diseases. * Fully remote and flexible work culture. * Competitive salary, equity, and benefits. Company DescriptionVivalink Campbell, CA Company Silicon Valley-based Vivalink () is an innovative connected healthcare devices company in its growth stage. The company develops wearable telemetry devices with integrated biometric sensors designed to continuously monitor human vitals and other indicators for medical and healthcare applications. These devices together with Vivalink’s related healthcare software products and services are offered to enterprise customers under a platform as a service model. Over 300 leading organizations, in more than 50 countries depend on our wearable human vitalssensors, software and services. With great products, more than 20 patents and brilliant people, what we do matters.Vivalink\r\nCampbell, CA\r\nCompany\r\nSilicon Valley-based Vivalink () is an innovative connected healthcare devices company in its growth stage. The company develops wearable telemetry devices with integrated biometric sensors designed to continuously monitor human vitals and other indicators for medical and healthcare applications. These devices together with Vivalink’s related healthcare software products and services are offered to enterprise customers under a platform as a service model. Over 300 leading organizations, in more than 50 countries depend on our wearable human vitalssensors, software and services. With great products, more than 20 patents and brilliant people, what we do matters.

Job Summary: The Clinical Trial Nurse I (CTN-I) is a novice level position which, under the guidance and supervision of the Principal Investigator (PI) and clinical trials administrative management, assists in ensuring that the integrity and quality of the clinical trial(s) are maintained and condu

Job Description Schedule: Hybrid 3x week on site The Divison of Hospital Medicine in the Department of Medicine is seeking a highly motivated and talented Administrative Team Lead (Administrative Associate 4). Under the general direction of the Assistant Division Manager, the Administrative Team Lead will supervise a team of three Administrative Associate 2s who support the day-to-day administrative and operational needs of the Division, in addition to providing complex administrative support to the Senior Leadership team, which consists of two Division Co-Chiefs, the Associate Chief, and the Administrative Division Director. The Administrative Team Lead will spearhead Division communications, event planning, and space allocation, direct the activities of an administrative team, independently manage Senior Leadership calendars, proactively identify and mitigate administrative issues, and create process improvements. The candidate must be highly organized, detail oriented, able to multi-task, and work independently under limited supervision. This exciting opportunity will require excellent judgement, communication, organization, time management, leadership and interpersonal skills, and the ability to take initiative. The successful candidate will work as part of a collaborative team and contribute to a positive and productive work culture. Our Division is comprised of 130 faculty members (and growing) spanning 5 diverse clinical sections, across 3 facilities in the Bay Area ( Health Care, Sequoia Hospital, and Tri-Valley). We are committed to excellence in clinical inpatient medicine, medical education, quality improvement, patient safety initiatives, and a broad research portfolio ranging from COVID-19 clinical trials to informatics and AI. Duties include: Act on behalf of the supervisor, department manager, or chair in regards to establishing priorities and identifying and resolving problems that are administrative in nature. Oversee and/or perform duties associated with scheduling, organizing, and operating complex conferences, seminars, and events, including arranging with vendors for services, overseeing the production and distribution of materials, administering logistics, and managing event within budget. Compose and draft documents and correspondence for presentations, course handouts, grants, conferences, seminars, and reports; perform substantial research editing and fact checking. Create, maintain, modify, and/or ensure accuracy of content in various unit documents, displays, reports, brochures, social media, and/or websites. Plan and schedule calendar(s) without prior consultation, resolve calendaring conflicts, and arrange travel in compliance with unit, university, and sponsor policies. Create complex reports and spreadsheets which may utilize specialized software and systems. Make recommendations based on reports. Oversee and/or process a variety of complex financial transactions; produce, monitor, and reconcile budget statements; research, identify, and resolve discrepancies. May assist with capital or special equipment requests and/or vendor selection. Positions at this level also include one or more of the following duties: In conjunction with financial lead and/or principal investigator, assist with sponsored project research proposal submissions and post award administration. Responsible for leading the administrative functions of a program or unit. Perform human resources transactional support and/or faculty affairs support; coordinate or manage the visa process. Serve as building coordinator. Oversee or supervise day-to-day work of other administrative or support staff, student and/or temporary workers, including scheduling, assigning, and prioritizing workloads, setting appropriate deadlines, reviewing work for quality and timeliness, and providing performance review input. Desired Qualifications: 2 or more years of prior supervisory experience. Exceptional organizational skills and attention to detail and accuracy. Demonstrated ability to prioritize own work, multitask, and respect deadlines. Excellent written, oral, and interpersonal communication skills. Personal effectiveness and credibility. Bachelors Degree Requirements: Top 3 requirements to hire Prior experience supervising administrative associates (ideally 2+ years) A bachelors degree Preferably prior work experience at or Health Care (SHC), though we are willing to compromise on this requirement if the candidate has particularly strong supervisory experience. Knowledge, Skills, And Abilities (Required): Advanced computer skills and demonstrated experience with office software and email applications. Proven success in following through and completing projects. Excellent organizational skills and attention to detail. Excellent verbal and written communication skills. Excellent customer service and interpersonal skills. Ability to prioritize, multi-task, and assign work to others. Ability to take initiative and ownership of projects. Ability to routinely and independently exercise sound judgment in making decisions. Physical Requirements: Constantly perform desk-based computer tasks. Frequently sitting. Occasionally stand/walk, reach/work above shoulders, grasp lightly/fine manipulation, grasp forcefully, use telephone, sort/file paperwork or parts, lift/carry/push/pull objects that weigh up to 10 pounds. Rarely twist/bend/stoop/squat, kneel/crawl.

Job Description Position Overview Elite Clinical Network (ECN) is seeking a dedicated and research-oriented Physician – Pulmonologist to join our expanding team of clinical professionals. The ideal candidate will play a critical role in the conduct of clinical trials by serving as a Principal Investigator (PI) or Sub-Investigator, while continuing to provide high-quality medical care to adult patients within a clinical research setting. This is a part time/per diem position with a unique opportunity to contribute to the advancement of medicine through clinical studies. Key Responsibilities • Serve as Principal Investigator or Sub-Investigator on multiple Phase I–IV clinical trials., • Perform comprehensive physical exams and clinical assessments for protocol screening and enrollment., • Evaluate patient eligibility based on inclusion/exclusion criteria of clinical protocols., • Provide medical oversight for clinical trial participants, including safety assessments, adverse event evaluations, and ongoing care., • Collaborate closely with Clinical Research Coordinators, Sponsors, and Monitors to ensure protocol compliance and data integrity., • Review and sign off on source documents, case report forms (CRFs), and regulatory documentation., • Maintain detailed and accurate clinical trial documentation in compliance with ICH-GCP, FDA, and sponsor requirements., • Participate in Site Initiation Visits (SIVs), Monitoring Visits, and Audits as needed., • Manage chronic and acute conditions among study participants in alignment with standard care and protocol guidelines., • Educate and counsel patients on study procedures, informed consent, and potential side effects., • Support recruitment efforts and promote patient retention in trials. Qualifications • MD or DO degree from an accredited medical school., • Valid, unrestricted medical license in the state of employment., • Board Certified or Board Eligible (BC/BE) in Pulmonology., • BC/BE in Family Medicine or Geriatric Medicine will also be considered., • Current Good Clinical Practice (GCP) certification or willingness to obtain prior to start., • Minimum of 1 year of experience in clinical practice; prior clinical research experience preferred but not required. Preferred Skills • Familiarity with FDA, ICH-GCP, and clinical trial protocols., • Experience managing or participating in industry-sponsored clinical trials., • Strong attention to detail and ability to document accurately., • Excellent interpersonal and communication skills for patient interaction and sponsor collaboration., • Ability to work collaboratively with a cross-functional team in a fast-paced research environment., • Comfortable using electronic medical records (EMRs) and clinical trial management systems (CTMS)., • DEA license (preferred).