At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Development Operations, you’ll provide strategic leadership and operational oversight for clinical trials across Insmed's development pipeline. This role is responsible for ensuring the successful planning and execution of clinical studies from protocol development through study closeout, while maintaining the highest standards of quality, compliance, and patient safety. This is a remote position. What You'll Do: In this role, you’ll have the opportunity to develop and implement clinical operations strategies, aligned with corporate objectives and Program goals. . You’ll also: - Provide functional subject matter expertise to the Global Program Team and develop clinical trial scenarios, options, timeline, and budget projections for decision-making. - Leverage broad clinical trial industry and biotech leadership experience to think beyond the clinical operations function and contribute to setting strategy for the Program, as requested. - Foster collaborative relationships with key external stakeholders, including clinical trial Investigators, Research Coordinators and Suppliers; Cultivate important relationships with key internal stakeholders, including Insmed senior management and cross-functional leadership. - Potentially serve on the Global Development Operations Leadership Team and contribute to setting Department strategy. - Ensure high-quality, consistent planning and execution of Phase I-IV clinical trials, including oversight of study feasibility, site selection, trial recruitment, data monitoring, study closeout, TMF, and study risk management. - Ensure compliance with GCP, FDA, EMA, and other regulatory requirements. - Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and other departments on the Global Clinical Team, responsible for delivery of trials within a Clinical Development Plan. - Partner with Procurement and Vendor Alliance Management to optimize external supplier performance, including establishing performance metrics, risk-sharing agreements, and partnership governance. - Benchmark, track, report, and evaluate operational and trial metrics, with the ability to interpret complex issues and communicate program status in a concise fashion to an executive audience. - Identify opportunities to improve the efficiency and/or effectiveness of clinical trial operations, develop strategies, make recommendations, and lead process improvement/enhancement initiatives. - Lead, coach, and develop a high-performing team of clinical operations professionals. - Manage resource allocation and capacity planning across multiple studies. - Foster a culture of quality, accountability, and patient-centricity. Who You Are: You have a Bachelors degree in life sciences, healthcare or a related field along with 12+ years of progressive clinical research/operations experience in the pharmaceutical/biotech industry and 5+ years in senior leadership roles managing clinical operations teams. You are or you also have: - Extensive experience across all phases of clinical research and across multiple therapeutic areas. - Robust knowledge of GCP, FDA regulations, and international regulatory requirements. - Proven track record of successful study execution and delivery in a fast-paced, dynamic environment. - Strong vendor management skills and CRO oversight experience. - Previous CRA/monitoring experience. - Experience in rare disease or respiratory therapeutic areas. - Experience with adaptive trial designs and innovative clinical trial methodologies. - Experience with regulatory submissions and Heath Authority inspections. Up to 25% domestic and international travel may be required for site visits, supplier meetings, and cross-functional/team collaboration. #LI-TB1 #LI-Remote Pay Range: $222,000.00-303,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: - Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) - Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance - Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities - Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.  Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Clinical Resource Specialist INCO Who We Are Essity is a global leader in health and hygiene headquartered in Stockholm, Sweden, with a North American headquarters located in Philadelphia, PA. We are a multi-billion-dollar company with a purpose to break barriers to well-being for the benefit of consumers, patients, care givers, and customers across the globe. We do this through innovations in our Professional Hygiene, Consumer Goods, and Health & Medical business units that provide hygiene and health solutions to over a billion people every day worldwide. Working at Essity is more than a career, it is where you will play your part in a better future, to improve well-being for people and have opportunities to drive positive change for society and the environment. As an employee at Essity, you will belong to a team where you feel valued, are safe, supported to grow and challenged to generate business results in a friendly and open atmosphere. About the Role Essity is looking for an experienced Clinical Resource Specialist, INCO. The Clinical Resource Specialist will be responsible for providing clinical expertise to customers through education and training on TENA products, while establishing and maintaining solid customer relationships. This person must understand customer needs across all segments to ensure that they clearly recognize a measurable value to our continence care and skincare products and programs. This role's primary focus will be providing clinical education to current and potential customers, set up trials and conversion. This role will report to the National Clinical Manager. This will be a remote position responsible for covering the Midwest/West region. The ideal candidate should live in the aligned Essity Regional structure and ability to travel often. We’re looking for people who embody our values, aren’t afraid to challenge, innovate, experiment, and move at a fast pace. We’re always looking for ways to improve our products and ourselves. If this is you, we’d love to talk.  What You Will Do - Provide expert clinical consultation within the assigned territory and travel within the United States as needed. - Deliver clinical presentations and educational programs to customers through live sessions, virtual formats, trade shows, and conferences. - Collaborate with Account Managers, National and Regional Key Account Managers, and distribution partners to support customer acquisition, business reviews, and overall account success. - Support and maintain corporate chain and regional accounts, including coordinating conversions, in-services for all shifts, and implementation of TENA programs. - Lead product trials for new accounts, gather documentation, and demonstrate measurable outcomes. - Serve as a trusted advisor by leveraging industry knowledge, case studies, benchmarking data, and white papers. - Partner with the Clinical Director and Marketing teams to roll out new clinical programs, tools, and educational content. - Identify opportunities to up-sell additional products and support strategic growth initiatives. - Maintain required organizational processes, including CRM documentation and expense management. - Participate in personal skill development and contribute to the clinical development of colleagues. - Operate in alignment with Essity’s beliefs and behaviors: Commitment, Courage, Collaboration, and Care. - Attend regional and national sales meetings, company trainings, and relevant industry events. - Collect and communicate market insights, competitor information, and benchmarking strategies to support business objectives. - Perform additional responsibilities as assigned to support organizational goals. Who You Are - LPN or RN - Three to Five (3-5) years of experience in the healthcare industry within clinical or account management - Requires ability to work day/night shifts, as needed - The ability to drive a motor vehicle and possession of a valid driver’s license is required - Strong customer focus and relationship building - Strong working knowledge of Microsoft Office (e.g. Word, Excel, Power Point) - Demonstrated ability to work both independently and collaboratively within teams - Strong analytical skills to be able to determine root cause for clinical fluctuations - Proven organizational & collaborative skills - Ability to manage time and priorities to meet deadlines - Excellent communication and presentation skills - Ability and willingness to travel up to 80% to domestic locations What We Can Offer You At Essity, we believe every career is as unique as the individual and empower employees to reach their full potential in a winning culture motivated by a powerful purpose. Compensation and Benefits: Expected Compensation Competitive annual salary + annual incentive bonuse + benefits Pay offered may vary depending on multiple individualized factors such as knowledge, skills, and experience. Along with competitive pay you will be eligible for the following benefits: - United Healthcare PPO / EyeMed Vision Insurance / Delta Dental Insurance - Wellness program provided through Rally - Healthcare and Dependent Care Flexible Spending Accounts (FSA) - 401(k) with employer match and annual employer base contribution - Company paid Basic Life, AD&D, short-term and long-term disability insurance - PTO offering with Paid Holidays - Scholarship program for children of Essity employees. Additional Information The Company is committed to equal employment opportunity and providing reasonable accommodations to qualified candidates and employees pursuant to applicable law. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, military and veteran status, gender identity or expression, genetic information, or any other characteristic protected by federal, state, or local law. If you require reasonable accommodation as part of the application process please contact EssityHRNorthAmerica@essity.com Together, we are improving lives, every day Working at Essity is not just a career; it is a chance to directly make the world a healthier, more hygienic and safer place. With impactful innovations coupled with sustainable solutions, we strive to reach more people every year with the necessary and essential solutions for well-being. Application End Date: Job Requisition ID: Essity260325

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations who bears primary responsibility for the execution of Telix’s clinical trials. The SCPM is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, quality, and team management in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The SCPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues. Key Accountabilities - Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout. - Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift. - Independently develop integrated study management plans with the core project team. - Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards. - Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget. - Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs. - Managing risks proactively and leading problem solving and resolution efforts - Support the development and maintenance clinical SOPs & trial process’ as required. - Developing project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed upon approach. - Management of complex multi-national, multi-center clinical research projects - Develop patient recruitment strategies - Conduct contract and budget negotiations with sites and vendors - Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders - Train study team members and act as mentor for CPMs - Work independently with limited supervision - Attend medical conferences and represent clinical operations through investigator engagement and/or presentations Education and Experience - Bachelor’s degree in life sciences required, PMP preferred - 5+ years of relevant experience in Clinical Trial Project Management required - Experience with late phase clinical trials (Phase 3 - 4, registration trials), oncology and/or radiopharmaceutical experience preferred. - Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines. - Team oriented mindset and demonstrates ability to work with cross functional teams. - Experience managing global clinical trials. - Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes. - Demonstrated ability to pivot study strategy quickly and lead teams in the right direction. - Strong analytical, organisational, planning, decision making, negotiation, and conflict management skills. - Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment. - Demonstrated leadership skills and ability to cultivate development of others - Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions (APAC, EMEA, NA)) Key Capabilities: - Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected - Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges - Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do - Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results - Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders - Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges - Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language - Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals - Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges - Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Clinical Project Manager (CPM) is responsible to support and oversee the day-to-day responsibilities of multiple early phase regional clinical trials from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, and quality in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The CPM will work closely with CROs and/or third-party vendors and closely collaborate with cross-functional internal and external stakeholders to ensure adherence to GCP, SOPs, and FDA/ICH guidelines and ultimate delivery of high-quality data within the defined timelines and approved budget. The CPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues. Key Accountabilities: - Support the planning and setup, maintenance and closeout phases of multiple concurrent clinical research studies - Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships - Provide day-to-day study management including, but not limited to oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team. - Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget. - Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc. - Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs - Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all study related issues - Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development / revision, data collection, patient safety / AE management, document management, statistical analysis / final report writing, and study close out. - Management of small or medium-sized projects or regional leadership of complex multi-center clinical research projects - Oversee the study specific Trial Master File (TMF) and assist with periodic audit of the TMF - Perform any other tasks/duties as assigned by management Education and Experience: - Bachelor’s degree in life sciences - At least 2 years of relevant experience in Clinical Trial Project Management - Strong understanding of all aspects of clinical trials; experience with early phase clinical trials (Phase 1 - 2), oncology and/or radiopharmaceutical experience preferred. - Ability to deal with multiple priorities with aggressive timelines. - Thorough knowledge of ICH GCP, drug development, clinical research industry practices and regulatory processes. - Strong analytical, organizational, planning, decision making, negotiation, and conflict management skills. - Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors and investigational sites. - Fluent in Microsoft Office products (Word, Excel, SharePoint, Teams, etc.) and proficiency using electronic platforms (CTMS, eTMF) . - Regional start-up experience (site feasibility, ethics & regulatory submissions) - Demonstrated ability to pivot study strategy quickly and lead teams in the right direction working in a fast-paced environment. - Experience in conflict resolution, clinical project management practice, risk management, and an understanding of project financials. Key Capabilities: - Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected - Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges(i.e., finding creative solutions to issues impacting timelines and/or budgets) - Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do - Results-oriented: Driven to achieve goals and corporate objectives, with a strong focus on delivering measurable results - Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders - Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges - Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language - Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals. A team player who can receive and provide constructive feedback - Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges - Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE