Director of Clinical Monitoring Oversight

At Olema Oncology, we are committed to pioneering innovative therapies for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), represents a groundbreaking complete estrogen receptor antagonist (CERAN) currently under development for metastatic breast cancer. This treatment holds the promise of being a game changer both as a standalone the…

Company Overview Avalyn Pharma is innovating the landscape of pulmonary fibrosis treatment through a groundbreaking pipeline of inhaled formulations. These approved medications are expertly designed to minimize systemic exposure and deliver targeted therapy directly to the affected areas. Pulmonary fibrosis, characterized by lung tissue scarring, diminishes lung function and quality of life, contributing to increased mortality rates. Conventional therapeutic options may slow disease progression but often come with significant toxicities that limit their application. Avalyn’s inhaled approach directly addresses the underlying causes of pulmonary fibrosis, aiming to enhance patient outcomes with reduced systemic side effects. Currently, Avalyn’s AP01, an optimized inhaled formulation of pirfenidone, is under investigation in the MIST Phase 2b study for progressive pulmonary fibrosis (PPF). This formulation has demonstrated clinical proof-of-concept with better efficacy and safety profiles compared to existing treatments, having been evaluated in over 150 patients with various forms of pulmonary fibrosis. Furthermore, Avalyn has completed two Phase 1 studies for AP02, an inhaled formulation of nintedanib for idiopathic pulmonary fibrosis (IPF), with plans for a Phase 2 clinical trial in the works. For more details, please visit avalynpharma.com and follow us on LinkedIn.

Join a dynamic, mission-focused startup dedicated to revolutionizing hearing aid performance in challenging environments. Fortell Research is seeking an enthusiastic and innovative Clinic Director to spearhead the launch of our inaugural clinic in Boston, introducing cutting-edge hearing technology to the residents of Massachusetts for the first time.This role presents a unique opportunity to establish and shape clinical operations, delivering exceptional care to Fortell Research’s first patients in the state. You will collaborate closely with our operations and product teams and serve as a pivotal clinical leader as we expand our presence.Key Responsibilities:Perform comprehensive diagnostic audiological assessments.Provide tailored consultations to clients, conveying test results and options in a compassionate and comprehensible manner.Recommend and sell Fortell Research hearing aids customized to meet individual client requirements.Fit, program, and adjust hearing aids for optimal performance and comfort.Provide ongoing support and maintenance for hearing aid users, including troubleshooting and repairs.Conduct real-ear measurements (REM) and test box measures to ensure accurate hearing aid fittings.Document all client interactions and outcomes meticulously and promptly.Educate clients and their families on hearing loss management and device maintenance as necessary.Maintain a clean, organized clinic environment while adhering to infection control protocols.Stay abreast of the latest advancements in audiology and hearing aid technologies.Oversee clinic operations, including inventory management, scheduling, and client follow-up, establishing best practices in a new clinic.Achieve key performance indicators related to conversion rates, client satisfaction, and operational efficiency to ensure high-quality care and robust business performance.Share clinical insights with management and product teams to enhance the Fortell Research patient experience.Act as a clinical leader and advocate for best practices in audiology.

BAYADA Home Health Care is seeking a dedicated and experienced Registered Nurse Executive to assume the role of Division Director of Clinical Operations within our Assistive Care (AC) and Assistive Care State Programs (ACSP). This pivotal leadership position demands an RN with extensive experience in clinical program development, care service delivery, and a strong commitment to clinical excellence focused on outcomes. Prior experience in home care, particularly with home health aide and personal care services for senior clients, is highly desirable.POSITION SUMMARY:In this role, you will work collaboratively alongside the Practice President, Regional Directors, and other clinical and operational leaders to supervise clinical leadership in the AC/ACSP practices. You will define care standards and drive the execution of high-quality care in line with BAYADA Home Health Care's mission and the standards set by regulatory and accrediting bodies. This position will also require you to liaise with the Chief Clinical Officer, Chief Nursing Officer, and Clinical Standards and Leadership (CSL) office leaders to establish clinical processes and implement effective strategies that promote exceptional patient outcomes and sustainable growth.This position will require regular travel (approximately 40%).

At Olema Oncology, we are committed to pioneering innovative treatments for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is a comprehensive estrogen receptor antagonist (CERAN) currently undergoing development for metastatic breast cancer, showcasing immense potential both as a standalone therapy and in combination for ER+/HER2- metastatic breast cancer. Additionally, our subsequent candidate, OP-3136, is a robust KAT6 inhibitor with the potential to set new standards in its class.Our scientific advancements are propelled by a culture that prioritizes fearless support, motivation, and mutual challenge among our team members. We believe that placing our people at the forefront allows us to achieve unparalleled results. If you are eager to be part of an unstoppable force, let's collaboratively make a significant impact for our patients, your career, and beyond.You can explore our latest corporate presentations here.About the Role: Associate Director of Clinical Supply ChainAs the Associate Director of Clinical Supply Chain, reporting directly to the Senior Director, you will be instrumental in planning, creating, implementing, and optimizing the clinical supply chain to guarantee a seamless and timely supply of clinical drugs for Olema's innovative programs.This role is positioned in our Boston office and will necessitate approximately 15% domestic or international travel.Your responsibilities will encompass:Comprehensive management of the clinical supply chainDevelopment and execution of global Clinical Supply Chain strategiesOversight of global inventories, shipping, and engagements with third-party manufacturers and logistics providersCreation and management of Interactive Response Technologies (IRT) systemsSupervision of packaging, labeling, and distribution tasks at various vendor locationsGeneration and management of clinical labelsIdentification of supply chain risks, escalation as necessary, and resolution of risk itemsCollaboration with Clinical Operations to ensure alignment on assumptions and the development of clinical supply to meet program demandsRepresentation of Clinical Supply Chain on study execution teams

Veeva Systems is a mission-driven organization and a leader in industry cloud solutions, dedicated to accelerating the delivery of therapies to patients. As one of the fastest-growing SaaS companies globally, we achieved over $3 billion in revenue last fiscal year and continue to explore extensive growth opportunities. Our core values include: Doing the Right Thing, Ensuring Customer Success, Fostering Employee Success, and Maintaining Speed. We are not just another public company – in 2021, we made history by becoming a public benefit corporation (PBC), legally committed to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we promote flexibility, allowing you to work from home or in the office, enabling you to excel in your preferred environment. Join us in transforming the life sciences industry and making a meaningful impact on our customers, employees, and communities.

Veeva Systems is a purpose-driven leader in the industry cloud sector, dedicated to assisting life sciences companies in accelerating the delivery of therapies to patients. As one of the most rapidly expanding SaaS organizations in history, we achieved over $3 billion in revenue in our last fiscal year, with significant growth opportunities on the horizon. Our core values at Veeva include: Doing the Right Thing, Customer Success, Employee Success, and Speed. We are not just an ordinary public company; we made history in 2021 by becoming a public benefit corporation (PBC), committed to balancing the interests of customers, employees, society, and investors. As a Work Anywhere organization, we foster flexibility, allowing you to work from home or in the office to thrive in your ideal environment. Join us in transforming the life sciences industry as we strive to make a positive impact on our customers, employees, and communities.

The Alliance for Clinical Trials in Oncology Foundation is dedicated to advancing cancer clinical research by expanding the capabilities of the Alliance for Clinical Trials in Oncology. Our mission is to address significant treatment challenges through large-scale clinical trials aimed at discovering innovative methods for the prevention, treatment, and cure of various cancers, including leukemia, lymphoma, and solid tumors such as breast, prostate, lung, and gastrointestinal cancers. We also strive to educate the medical community on effective cancer diagnosis, treatment, and prevention strategies.In 2014, we established the Alliance Foundation Trials, LLC (AFT), a wholly-owned subsidiary focused on conducting impactful cancer clinical research in collaboration with industry partners.We are currently seeking a Clinical Research Associate (CRA) to play a crucial role in the management and execution of clinical trial operations across AFT studies. The CRA will be responsible for site management and study start-up activities, including conducting feasibility assessments, supporting site selection, maintaining trial master files (eTMF), and overseeing clinical trial management systems (CTMS). The ideal candidate will work closely with CROs, vendors, and investigative sites to ensure compliance with ICH GCP guidelines and organizational standards throughout the study lifecycle. Join our team of dedicated professionals passionate about transforming cancer care.

At Veeva Systems, our mission is to accelerate the delivery of therapies to patients through innovative cloud solutions tailored for the life sciences industry. As a trailblazer in the SaaS sector, we achieved over $3 billion in revenue last fiscal year and are poised for significant future growth. Our core values—Doing the Right Thing, Customer Success, Employee Success, and Speed—guide every aspect of our operations. In 2021, we distinguished ourselves by becoming a public benefit corporation, legally committed to balancing the interests of all stakeholders including customers, employees, society, and investors. As a Work Anywhere organization, we empower our employees to work in their preferred environments, whether from home or in the office, fostering their success and well-being. Join us as we transform the life sciences industry and create a positive impact for our customers, employees, and communities.

Veeva Systems is a visionary organization dedicated to advancing the life sciences sector through innovative cloud solutions, enabling companies to deliver therapies to patients more efficiently. As one of the fastest-growing SaaS companies in history, Veeva has achieved over $2 billion in revenue in our most recent fiscal year, with significant growth opportunities on the horizon.Our core values—Do the Right Thing, Customer Success, Employee Success, and Speed—guide us in our mission. We made headlines in 2021 by becoming a public benefit corporation, committed to balancing the interests of our customers, employees, society, and investors.As a Work Anywhere company, we empower our employees with the flexibility to work from home or in the office, fostering an environment where everyone can thrive.Join us in transforming the life sciences industry, and making a meaningful difference for our customers, employees, and communities.The RoleVeeva Systems is on the lookout for a dynamic and accomplished Senior Director of Clinical Strategy to spearhead the growth and adoption of our OpenData Clinical product within the Clinical Operations portfolio. This strategic leader will be instrumental in defining, constructing, and executing strategies to expand our clinical data products business.The ideal candidate will possess a robust combination of strategic insight, commercial acumen, and deep knowledge of data products in the Life Sciences sector, with a focus on clinical research sites and investigators. This role demands the ability to operate at an executive strategy level while ensuring meticulous cross-functional execution.

About EyebotEyebot is a visionary technology firm dedicated to revolutionizing vision care accessibility for all. Based in the vibrant North End of Boston and supported by esteemed investors and the National Science Foundation, our innovative vision test kiosk is transforming the delivery of vision care.If you are driven by the passion to tackle significant challenges while helping to shape the future of vision care, we eagerly invite you to connect with us.About the RoleWe are seeking a dynamic Head of Regulatory Strategy & Clinical Development to chart our market approach. In this pivotal role, you will craft and implement the FDA regulatory strategy for our cutting-edge AI-powered ophthalmic diagnostic platform, managing 510(k) submissions, Pre-Submissions, and CE marking compliance under the EU MDR. This leadership position offers direct visibility to executives and significant influence over product outcomes.Your Responsibilities:U.S. FDA StrategyEstablish and execute comprehensive FDA regulatory strategies, including predicate selection, intended use definition, and risk assessment.Lead the drafting and submission of Pre-Submission and 510(k) applications from inception to clearance.Act as the primary liaison for all FDA interactions, including meetings, Q-Submissions, and formal communications.Ensure risk management, labeling, and software documentation align with FDA guidelines.EU CE MarkingDirect the EU MDR regulatory strategy and manage the CE marking process comprehensively.Create and uphold the Technical File; facilitate interactions and audits with Notified Bodies.Monitor post-market surveillance and vigilance, ensuring consistency between U.S. and EU regulatory perspectives.Clinical Strategy & ExecutionIdentify when clinical evidence is necessary and specify the required evidence scope.Design and implement clinical study protocols and statistical analysis plans.Oversee IRB submissions, site coordination, study execution, data integrity, and final reporting.Program & Cross-Functional LeadershipManage regulatory program timelines across hardware, software, clinical, and labeling workflows.

Join SimpliSafe, a leader in home security solutions, as a Senior Product Manager for Monitoring Service Delivery. In this pivotal role, you will spearhead the development and implementation of innovative monitoring services that enhance our customer experience. Collaborate with cross-functional teams to define product vision, strategy, and roadmap while driving the execution of product initiatives. Your expertise will be vital in optimizing service delivery processes to ensure high-quality performance and customer satisfaction.

Join our dynamic team at Alimentiv as a Senior Clinical Operations Lead, where you will play a pivotal role in shaping the future of clinical trials. We are looking for a strategic thinker with extensive experience in clinical operations to lead our initiatives and ensure the successful execution of clinical studies.

Established in 2004, BME Strategies is a premier consulting firm headquartered in Massachusetts, dedicated to the design, execution, and evaluation of public health initiatives for government entities at local, regional, and state levels. Our mission is to empower evidence-based, community-centric solutions that enhance public health frameworks and promote equity throughout the communities we serve.Position OverviewThe Public Health Consultant specializing in Monitoring, Evaluation & Quality Improvement is pivotal in crafting, managing, and executing data-centric projects aimed at bolstering public health infrastructures and fostering community wellness. The ideal candidate will possess proven expertise in monitoring and evaluation (M&E), quality improvement (QI), epidemiology, or public health accreditation, and will be committed to enhancing client capacities in these domains. This role will report directly to the Managing Consultant, MEQ.By collaborating closely with BME’s leadership and partners, Consultants will apply their specialized knowledge in areas such as performance management system development, data analysis and visualization, accreditation readiness, community health assessment (CHA/CHIP) support, epidemiologic evaluations, and QI capacity enhancement. Additionally, Consultants may engage in related project activities including strategic planning, training development, emergency preparedness, and workforce development.This opportunity is ideal for individuals who are methodical, analytical, detail-oriented, and passionate about enabling public health departments to enhance their frameworks through informed decision-making. The successful candidate will relish working alongside clients and communities to identify their challenges and needs, deriving actionable insights from data, and contributing to accreditation or performance improvement initiatives while being part of a supportive and high-performing remote team.Key ResponsibilitiesMonitoring, Evaluation, Epidemiology & Quality ImprovementLead and support M&E initiatives, encompassing logic model creation, indicator development, data collection strategy, analysis, interpretation, and reporting.Conduct epidemiological studies, surveillance assessments, community health evaluations, and other data-driven inquiries that guide client priorities.Design and execute QI frameworks that pinpoint improvement opportunities, facilitate QI initiatives, coach teams in QI methodologies, and produce associated tools and guidance.Assist with public health accreditation (e.g., PHAB) readiness, involving performance management systems, documentation assessment, domain mapping, and the formulation of necessary plans and policies.Engage in community outreach efforts, utilizing participatory evaluation and assessment methodologies.Project Leadership & Client SupportOversee and manage public health projects and programs, ensuring timely completion of deliverables and maintaining high-quality standards.

The Clinical Safety Specialist will collaborate with the clinical safety team to oversee the implementation of InterSystems' Clinical Safety Management Framework, enhancing the development and execution of our innovative healthcare products.Key ResponsibilitiesDeliver clinical safety assurance services across all InterSystems products.Modify and enhance InterSystems’ Clinical Safety Management Framework and Plan for optimal application.Serve as the primary escalation point for clinical safety concerns.Prepare Safety Reports based on issues escalated by customers, implementation, and support teams.Conduct thorough clinical safety assessments to evaluate clinical risks and promote patient safety improvements.Collaborate effectively within a multi-disciplinary team, including regional editions, implementation, and support.Facilitate clinical safety training sessions for internal and external stakeholders.Engage in activities of the Clinical Safety Group.Develop and maintain clinical safety documentation for regions and projects.Provide expert clinical safety and risk assessment guidance on customer sites.Share insights and experiences with customers and the InterSystems team pertaining to clinical safety best practices.Be ready to assume the role of Clinical Safety Officer or act as a Clinical signatory for InterSystems as required.

Welcome to knownwell, a pioneer in weight-inclusive healthcare solutions. Join our innovative team that is transforming obesity care delivery through a comprehensive approach that includes weight management, primary care, nutrition counseling, and health coaching. Our unique care model integrates both in-clinic and virtual services to ensure that patients receive the support they need, exactly when they need it.With $50 million in funding—including a $25 million round led by CVS Health Ventures and supported by a16z Bio + Health, Flare Capital, MassMutual, and Intermountain Ventures—we are rapidly expanding access to evidence-based obesity care across the nation. As the Clinical Research Coordinator (CRC), you will oversee and synchronize all facets of our clinical trials. Your role is vital in ensuring compliance with regulatory requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines. You will serve as the primary point of contact between the clinical research team, patients, and external stakeholders, facilitating the efficient and timely execution of clinical research initiatives.

Veeva Systems is a pioneering organization dedicated to transforming the life sciences sector through innovative industry cloud solutions. Our mission is to expedite the delivery of therapies to patients, and our impressive growth trajectory reflects our commitment, having surpassed $3 billion in revenue in the last fiscal year. At Veeva, our core values are paramount: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), ensuring a balanced approach to serving the interests of our customers, employees, society, and investors. As a Work Anywhere company, we empower you to choose your ideal work environment, whether at home or in the office, to maximize your potential. Join us in revolutionizing the life sciences landscape, with a commitment to making a meaningful impact on our customers, employees, and the communities we serve.

Join our dynamic team as a Clinical Investigator specializing in Breast Oncology or Hematology. In this role, you will conduct groundbreaking research and clinical trials, contributing to the advancement of cancer treatment. You will collaborate with top researchers and healthcare professionals to drive innovative solutions in patient care.

Become a Pioneer in the Sleep Fitness RevolutionJoin Eight Sleep, where our mission is to enhance human potential through exceptional sleep quality. As the world's first sleep fitness company, we are transforming the concept of well-being and creating cutting-edge hardware, software, and AI technology to facilitate optimal sleep. Our innovative products are designed to maximize mental, physical, and emotional performance, turning each night into a personalized, data-driven recovery session. Trusted by elite athletes and health-conscious individuals across over 30 countries, we are at the forefront of the sleep revolution.Featured as one of Fast Company's Most Innovative Companies in multiple years, we are committed to building a high-performance team that prioritizes speed, focus, and impactful results. Our culture is characterized by an obsession with detail and continuous improvement to ensure our members achieve better sleep and stronger mornings.Unwavering Standards and CommitmentOur intensity reflects the demands of our mission at Eight Sleep. We strive for excellence, inspired by the dedication of top performers worldwide. We are a team that operates with focus and tenacity, constantly pushing to excel in our craft. This is not a conventional 9-to-5 job. Our team is deeply engaged, often going above and beyond because we are passionate about our work.If you thrive under pressure and seek to make a significant impact in your career, you will find your place here. However, if you prefer an easy-going environment, this may not be the role for you.Your RoleWe are in search of a Senior Clinical Trial Manager to oversee the comprehensive execution of our clinical studies, including regulatory trials. This operationally intensive role requires a hands-on approach and expertise in initiating studies from the ground up, managing third-party clinical sites, drafting IRB and informed consent documents, overseeing data management, and ensuring timely and budget-compliant study completion.You will serve as a vital link between our internal teams and external clinical sites, investigators, IRBs, CROs, and, when needed, study participants. A strong understanding of regulatory requirements for medical devices and a proven track record of successful clinical study delivery supporting regulatory submissions are essential.

Join our dynamic team at Precede as a Senior Clinical Laboratory Associate, where your expertise will play a pivotal role in advancing our clinical testing capabilities. You will lead laboratory operations, ensuring the highest standards of quality and accuracy in all testing procedures.Your responsibilities will include overseeing clinical trials, managing laboratory staff, and collaborating with cross-functional teams to interpret complex data. We are looking for a detail-oriented professional who thrives in a fast-paced environment and is passionate about contributing to innovative health solutions.