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A tech company specializing in data streaming is seeking a Director, Technical Revenue and Assurance. The role involves leading the revenue policy framework and providing strategic advice on ASC 606 compliance. Candidates should possess at least 10 years of experience, strong leadership skills, and knowledge of US GAAP. The position is remote-friendly, ideal for those who thrive in a collaborative environment. Join a culture that values diverse perspectives and continuous improvement. #J-18808-Ljbffr

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one' to the future they've envisioned. POSITION SUMMARY: Day One Biopharmaceuticals is seeking a creative, intelligent, deeply committed, high-integrity, scientific leader to develop and maintain precision medicine vision and strategy and provide expertise in clinical diagnostics across our portfolio of targeted therapeutics for children and adults with cancer. In conjunction with senior leaders in Clinical Development, Translational and Precision Medicine, Regulatory Sciences and supported by a deeply experienced cross-functional team of experts in drug development, you will be responsible for ensuring the consistent application of precision medicine and diagnostics across all stages of clinical development. This individual will be a key member of the Translational and Precision Medicine Team within our Research and Development organization and will report to our Head of Precision Medicine. This role is expected to be a precision medicine functional lead on product teams with influence across all programs, though initially operating as a hands-on individual contributor. This position has the potential to be fully remote. Occasional travel will be required for in-person meetings. ESSENTIAL DUTIES AND RESPONSIBILITIES: Develop and maintain precision medicine vision and strategy through cross-functional partnership with Leadership of Clinical Development, Translational Research, Regulatory Sciences, Clinical Pharmacology, and Commercial, as well as other Day One functions Design and implement hypothesis-driven strategies to deliver evidence of target engagement, mechanisms of action/resistance, patient selection/CDx strategies and other clinically-relevant biomarker endpoints to advance the Day One pipeline Provide technical, clinical and regulatory expertise in assay development and diagnostics (NGS, IHC, Immunoassays along with emerging biomarker technologies and platforms) across diverse stakeholders comprising leadership in Research and Development, Commercial, Regulatory Sciences, Medical Affairs, and Patient Advocacy, including but not limited to, training, education, and representation on behalf of our Translational and Precision Medicine-related events Effectively partner with Precision Medicine leaders to execute on the development of clinical biomarkers, assay development through companion diagnostics to maximize patient access to Day One drugs Manage external diagnostic partners, CROs, academic collaborators, and vendors to ensure high-quality biomarker and CDx deliverables. Leadership expertise in developing and maintaining precision medicine screening strategies across clinical programs, leveraging your extensive experience in testing report interpretation Author and review Precision Medicine related publications as well as appropriate sections in clinical study / regulatory documents (i.e. INDs, IBs, trial protocols/ops manuals, ICFs, IRB responses, HA Briefing Books, CSRs, etc.) Work closely with Business Development and Precision Medicine leaders to support candidate asset acquisition assessments through clinical biomarker and CDx considerations Develop and implement comprehensive clinical biomarker strategy across clinical programs Lead the strategic planning and execution of CDx development, including assay selection, analytical validation strategies, clinical validation plans, and alignment with regulatory and commercial partners. Help Day One remain a leader in oncology drug development across all ages Engaging, inspiring, and successfully communicating with employees of any level in the organization. Understanding and embracing one of our highest values: that the most precious asset is our team. Proactively contributing to company-building and process evolution as we grow QUALIFICATIONS Bachelor's degree (PhD or MD/PhD preferred) in biology, immunology, chemistry, pharmacology, biochemistry, or related discipline 10+ years' experience in commercial diagnostic testing and/or oncology drug discovery/development setting within the biopharmaceutical industry (biotech or large pharma). A diverse background across assay, diagnostics, cancer biology, and drug development is required with relevant expertise in the interpretation of clinical molecular diagnostic testing reports, and understanding of clinical biomarkers and Companion Diagnostics development strategy and execution is strongly desired Pediatric oncology and/or rare disease experiences are highly desirable, Ability to interpret complex molecular and clinical datasets and translate insights into program strategy Unwavering integrity and trustworthiness, embodying Day One's core values Eloquent and passionate when talking about science and the potential to help patients Keen scientific acumen and intellectual curiosity, good judgement, and the highest scientific integrity Curious, creative with an ability to think outside of traditional drug development and corporate models A team player and a mentor - someone who cares for their colleagues as people as well as contributors and collaborators, while delivering results Inspires the confidence of others, and inspires others to fulfill their potential The ability to elicit and synthesize information from a range of individuals and sources rapidly and clearly communicate findings across the organization Start-up/small biotech experience is strongly preferred or a clear desire to dive into working with a small team. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. INTERVIEW INTEGRITY At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone. COMPENSATION AND BENEFITS The salary range for this position is $215,000 - $230,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary. Please visit ********************************** to see our competitive benefits. DISCLAIMER Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. We are unable to sponsor or take over sponsorship of any applicant work visas at this time. Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical's internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.

All interested applicants should attach a resume in the Supporting Documents section of the application, preferably in a PDF format to avoid any formatting issues. About Rice: Boasting a 300-acre tree-lined campus in Houston, Texas, Rice University is ranked among the nation's top 20 universities by U.S. News & World Report. Rice has a 6-to-1 undergraduate student-to-faculty ratio, and a residential college system, which supports students intellectually, emotionally and culturally through social events, intramural sports, student plays, lectures series, courses and student government. Developing close-knit, diverse college communities is a strong campus tradition, which is why Rice is highly ranked for best quality of life and best value among private universities. Rice is also a wonderful place to work. Rice faculty, staff, and students share values that are essential to our success as a healthy community. Those values guide our decisions and behaviors and shape Rice's culture. They come through in the way we treat each other and the welcome we extend to our visitors. These values can be recalled simply by our name - RICE - Responsibility, Integrity, Community and Excellence. Position Summary: The Associate Athletic Director / Sports Medicine & Sports Performance will serve as the Health Care Administrator, a position required by the NCAA. Additionally, the position will direct and administer all areas of sport performance, including athletic training, strength & conditioning, sports nutrition, technology and diagnostic testing, sports psychology, and all contracted medical services, including team physicians and physical therapists. This position will be the department's day-to-day interface with the Houston Methodist Human Performance Center and will be responsible for working with the Office of the General Counsel and Risk Management on all risk mitigation protocols related to student-athlete safety. Further, this person will serve as the chief liaison for head coaches on concerns related to team and student-athlete performance and policy issues. This includes all drug testing policies/procedures/protocols, as well as any other related duties to be assigned. The overarching responsibility of this position is to ensure the implementation of best practices and programming to maximize the safety, development, and performance of Rice University student-athletes. Work Requirements: This position is exclusively on-site, necessitating all duties to be performed in person. Per Rice policy 440 , work arrangements may be subject to change. This role is classified as an Essential On-Campus Position, requiring on-site presence to effectively carry out its vital functions. During emergencies or crises, the employee is required to report to campus as directed to ensure continuity of critical operations and must remain accessible to leadership to fulfill responsibilities necessary for maintaining institutional functions. Hiring Range: Commensurate based on education and experience Minimum Requirements: Bachelor's Degree in Kinesiology, athletic training, sports medicine, or related field Five or more (5+) years of experience in secondary and/or collegiate full-time experience in athletic training at the assistant/associate level License/Certification: NATA certification; CPR certification Must possess (or have the ability to obtain one within 30 days of hire) and maintain a valid Texas driver's license with no more than three moving violations and/or at fault accidents within the past 36 months, and no convictions or deferred dispositions for Driving While Intoxicated (DWI) or Driving Under the Influence (DUI) within the past five years. Preferences: Master's Degree or higher in kinesiology, athletic training, sports medicine, or related field Five years of supervisory experience in college athletics Seven or more (7+) years of experience in secondary and/or collegiate full-time experience in athletic training at the assistant/associate level Essential Functions: Serves at the NCAA Institutional appointed Health Care Administrator Advises Coordinated Services for Human Performance and Research Center at the direction of Athletics Director Provides input, feedback and responds to General Counsel regarding all Student Health Care and Health Care Liability Negotiates Medical Provider Services with the Medical Director, Head Team Physician Facilitates and Assists with Mental Health Wellness Coordination Supervises athletic trainers, nutrition specialists, strength coaches, and other positions as assigned. Provides management and administrative oversight for assigned program(s) Develops strategies to maximize resources and performance Performs all other duties as assigned Rice University HR | Benefits: *************************************** Rice Mission and Values: Mission and Values | Rice University Rice University is committed to ensuring Equal Employment Opportunity and welcoming the fullness of diversity into our candidate pools. Rice considers qualified applicants for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national or ethnic origin, genetic information, disability, or protected veteran status. Rice also provides reasonable accommodations to qualified persons with disabilities. If an applicant requires a reasonable accommodation for any part of the application or hiring process, please get in touch with Rice University's Human Resources Office via email at ******************** for support. If you have any additional questions, please email us at *************. Thank you for your interest in employment with Rice University.

The Role: Moderna is seeking a Director of Clinical Operations to manage oncology programs which may consist of one or more studies. This is a clinical operations program management role. This position will be responsible for initiating and leading clinical programs, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations, Therapeutics and Oncology with a focus on oncology. This position will work collaboratively across the oncology development and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. Here's What You'll Do: * Accountable for delivery of assigned clinical program budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives * Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan * Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders * Oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs * Support the selection, oversight, and management of CROs and other vendors * Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team * Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate * Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations * Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. * Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders * Perform and document study level Sponsor Oversight of outsourced clinical activities * Communicate study-status, cost and issues to ensure timely decision-making by senior management * Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct * Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance * Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives * Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna * Support program level deliverables/activities * Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff. * Strive for continuous improvement and more efficient ways of working in clinical development * Act as a role model for Moderna's values Here's What You'll Bring to the Table: * Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred. * Robust experience in oncology required. Late-stage/phase 3 experience required. Experience in immuno-oncology is desirable but not required. * Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc. * Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc. * Experience in GCP inspections/audits * Outstanding verbal and written communication skills, in addition to excellent organizational skills * Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry * Resilient, Creative, capable problem-solver * Excellent organizational skills and ability to work independently * Experience in establishing and maintaining relationships with key opinion leaders * Some travel required Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. * Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs * A holistic approach to well-being, with access to fitness, mindfulness, and mental health support * Family planning benefits, including fertility, adoption, and surrogacy support * Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown * Savings and investment opportunities to help you plan for the future * Location-specific perks and extras The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 *

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: The Senior Director, Clinical Operations leads and drives program oversight in conjunction with Clinical Development and Project Management (PM) for an indication's life cycle for a single asset. This role also partners with Clinical Development and PM to define overall strategy toward achieving/exceeding program specific corporate targets, identifying and mitigating potential issues, and ensuring budget and timeline compliance. Additionally, the role serves as an escalation point and resolution resource for operational issues and decision gates. Lastly, the role will involve direct supervision and mentoring of clinical operations team members. Key Responsibilities: Contributes to program strategy, resourcing, budgeting, project plans, and oversight for clinical studies to achieve clinical program goals Guides and supports trial management activities including budget management, study management, CRO/Service Provider oversight, risk mitigation and Good Clinical Practices Leads the CRO/vendor selection strategy to support assigned studies, oversee the documentation for contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies Supervise and direct clinical trial activities to ensure adherence to internal SOPs, as well as adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents. Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes Provide input to the drafting of governance documents, SOPs, work instructions, and other resources Leads and/or participates in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality or other business objectives Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation and oversees appropriate progress and timely completion of trials and deliverables according to established milestones and goals Collaborate cross-functionally to oversee the clinical operations aspects of work processes involving site management, medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science Provide input to the drafting of governance documents, SOPs, work instructions, and other Manage clinical operations manager/assistants, including effective performance reviews, feedback, mentoring, coaching and development of staff Requirements: Bachelors in Life Sciences with an advanced degree preferred At least 15 years of experience in the pharmaceutical industry, with at least 10 years in a clinical leadership role on a cross-functional drug development project team. Experience working at a CRO, small pharma or biotech company is a plus. PMP is a strong plus. Experience executing complex global development programs across all phases of clinical research (Phases 1-4) Experience leading a cross functional team is a strong plus Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations is required Experience selecting and oversight of CROs/vendors required Experience in rare disease therapeutic areas and patient engagement strategies preferred Ability to function in a fast pace, dynamic environment Ability to deal with ambiguity Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans Strong interpersonal and negotiation skills Proven complex problem solving and decision-making skills Must be a demonstrated self-starter and team player with strong interpersonal and communication skills Excellent written and verbal skills Must display strong analytical and problem-solving skills Direct supervisory experience Unrelenting dedication to delivering quality results Integrity, in word and action Willingness to roll up your sleeves to get the job done Work Environment: • Remote-based; Immunovant's headquarters is in NYC • Dynamic, interactive, fast-paced, and entrepreneurial environment • Domestic or international travel is required (20%) Salary range for posting$275,000-$285,000 USD Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

Let's build the future of medicine - together. Join Enveda as a Sr. Director, Clinical Operations and help us transform natural compounds into life-changing medicines. We're a team driven by curiosity and innovation - are you ready to make a difference? Remote | Full-Time | $225,000 - $275,000 What Makes Us Enveda Life is smart, and we can learn from it. We're reinventing drug discovery by harnessing nature's intelligence. Our platform identifies new medicines four times faster than the industry standard because patients can't wait. What sets Enveda apart isn't just what we do - it's how we do it. Our culture is built on creativity, collaboration, and deep respect for each other. We believe “People Create All Value” , and our success is driven by the extraordinary team turning our mission into reality every day. We're proud of the momentum we've built. Our Momentum - Unicorn status: Achieved following a $150 million Series D funding round in 2025 - Discovery and innovation: Advanced our first drug candidate to Phase 1 trials in 2024 - Award-winning culture: -- Newsweek : Top 100 Global #MostLovedWorkplaces (2025) -- Forbes : America's Best Startup Employers (2024 & 2025) -- Newsweek : America's Greatest Startup Workplaces (2025) -- LinkedIn : Top Startups to Watch (2024) These milestones reflect the impact of our team and we're just getting started, but they're only possible because of the diverse talent, perspectives, and relentless drive of our team, and people like you. Your Role in Our Mission At Enveda, every role drives impact. As a Sr. Director, Clinical Operations, you'll be at the forefront of delivering hope to patients everywhere. Your expertise in leading global clinical trials will be critical in accelerating our mission to bring new treatments for Inflammatory Bowel Disease (IBD) because every breakthrough starts with bold questions and brave actions.What You'll Do Lead the operational strategy and execution of IBD clinical development programs Oversee an outsourced clinical operations model ensuring rigor, speed, and compliance Collaborate with cross-functional teams to ensure operational feasibility and alignment Build, mentor, and lead a high-performing Clinical Operations team and external partners We're Looking For A seasoned clinical operations leader with 12-15+ years of experience Proven track record managing CROs and vendors in complex, multi-center, international studies Strong working knowledge of ICH-GCP, FDA/EMA regulations Experience in IBD, immunology, or related inflammatory diseases preferred If you're passionate about innovation and impact, we encourage you to apply even if you don't meet every requirement. Our Values: Curiosity | Agency | Journey | Charity | Unity Benefits: 90% Medical, Dental, Vision | 401k Match | Flexible PTO | Adoption Assistance Enveda is protecting Job Seekers:We care deeply about creating a safe, respectful experience for every applicant, so we wanted to share a few guidelines to help you spot anything that doesn't feel right. --You'll always meet real Enveda team members through video or in-person conversations before receiving an offer. --All communication from us will come from an @enveda.com or @envedabio.com email address. --We'll never ask you to purchase equipment, send money, or share sensitive banking details as part of any step in our recruiting process. If something feels off or you're unsure whether a message is truly from Enveda, please reach out at anytime at *********************. At Enveda, we're building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. Apply now and join a team committed to shaping the future of drug discovery.

Omada Health is on a mission to inspire and engage people in lifelong health, one step at a time. Under the guidance of the Chief Care Delivery Operations Officer, the Senior Director of Clinical Operations & Practice is a strategic leadership role in Care Teams responsible for overseeing all aspects of Omada's clinical operations (currently: CDCES, exercise specialists, on-call program, third party prescribing operations) including member outcomes & engagement, cost and employee engagement. This role will be the primary operating partner to the Clinical organization for strategically expanding clinical programming outlined in Omada's 5 year program vision. This individual will lead cross-functional teams inside of and outside of their direct reporting line to optimize operations for all clinical conditions across Care Teams. This role will leverage technology and data insights to optimize clinical operations delivery. This role will lead continuous improvement of clinical operations. Your Impact: Develop & implement long-term, comprehensive clinical operations strategies (i.e. T1D, T2D, HTN, Hyperlipidemia, GLP1s, AOMs….) focused on member experience, clinical quality, team efficiency, and employee experience. Cultivate a strong, cohesive clinical operations leadership team that effectively oversees day to day operations, ensures clinical safety & compliance, and collaborates seamlessly with cross functional Care Team leaders (i.e. Member Services, Health Coaching, MSK, Operational Excellence…). Serves as the primary operating partner to the Clinical team for condition specific program development, translating long term clinical strategy (i.e. prescriber operations) into multi-year operating strategies. Leads all operational execution. Establishes robust partnership with Care Teams Operational Innovation (CTOI) to ensure operational readiness for new product integration, product optimization, AI care team of the future implementation and ensures strong ‘voice of clinical operations' representation within CTOI. Leads operational excellence within clinical operations including continuous improvement strategies/projects, operating metrics review/improvement, and standardization where appropriate. To be successful, you will need: Minimum of 10+ years of progressive leadership experience in healthcare or clinical operations, with a strong emphasis on operational strategy and execution. Required: active RN, RD or ARNP license Demonstrated success in leading complex operational initiatives in dynamic environments. Exceptional communication and leadership skills, with the ability to inspire and cultivate strong culture. Minimum of 5+ years of performance improvement practice To stand out: Experience within the healthcare technology sector. Virtual care delivery experience. MBA or MHA Advanced clinical practice degree CDCES certification Working conditions: Remote-first environment. Travel requirements may be up to 25%. Benefits: Competitive salary with generous annual cash bonus Equity Grants Remote first work from home culture Flexible vacation to help you rest, recharge, and connect with loved ones Generous parental leave Health, dental, and vision insurance (and above market employer contributions) 401k retirement savings plan Lifestyle Spending Account (LSA) Mental Health Support Solutions ...and more! It takes a village to change health care. As we build together toward our mission, we strive to embody the following values in our day-to-day work. We hope these hold meaning for you as well as you consider Omada! Cultivate Trust. We actively cultivate trust through attentive listening and supporting one another. We respectfully provide and are open to receiving candid feedback. Seek Context. We ask to understand and we build connections. We do our research up front to move faster down the road. Act Boldly. We innovate daily to solve problems, improve processes, and find new opportunities for our members and customers. Deliver Results. We reward impact above output. We set a high bar, we're not afraid to fail, and we take pride in our work. Succeed Together. We prioritize Omada's progress above team or individual. We have fun as we get stuff done, and we celebrate together. Remember Why We're Here. We push through the challenges of changing health care because we know the destination is worth it. About Omada Health: Omada Health is a between-visit healthcare provider that addresses lifestyle and behavior change elements for individuals managing chronic conditions. Omada's multi-condition platform treats diabetes, hypertension, prediabetes, musculoskeletal, and GLP-1 management. With insights from connected devices and AI-supported tools, Omada care teams deliver care that is rooted in evidence and unique to every member, unlocking results at scale. With more than a decade of experience and data, and 29 peer-reviewed publications showcasing clinical and economic proof points, Omada's approach is designed to improve health outcomes and contain costs. Our customers include health plans, pharmacy benefit managers, health systems, and employers ranging from small businesses to Fortune 500s. At Omada, we aim to inspire and empower people to make lasting health changes on their own terms. For more information, visit: **************************** Omada is thrilled to share that we've been certified as a Great Place to Work! Please click here for more information. We carefully hire the best talent we can find, which means actively seeking diversity of beliefs, backgrounds, education, and ways of thinking. We strive to build an inclusive culture where differences are celebrated and leveraged to inform better design and business decisions. Omada is proud to be an equal opportunity workplace and affirmative action employer. We are committed to equal opportunity regardless of race, color, religion, sex, gender identity, national origin, ancestry, citizenship, age, physical or mental disability, legally protected medical condition, family care status, military or veteran status, marital status, domestic partner status, sexual orientation, or any other basis protected by local, state, or federal laws. Below is a summary of salary ranges for this role in the following geographies: California, New York State and Washington State Base Compensation Ranges: $216,200 - $270,300*, Colorado Base Compensation Ranges: $206,800 - $258,500*. Other states may vary. This role is also eligible for participation in annual cash bonus and equity grants. *The actual offer, including the compensation package, is determined based on multiple factors, such as the candidate's skills and experience, and other business considerations. Please click here for more information on our Candidate Privacy Notice.

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders. We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients! About the Position: Edgewise is headquartered in Boulder, Colorado and this is a remote position for a growing Clinical Development team based in and around the east coast. The assigned clinical trials will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to lead/provide oversight for more than one study or across programs and be assigned direct report(s). Essential Job Duties and Functions: Provide operational expertise and strategic input for assigned clinical trials. Provide expertise and operational input into protocol synopsis, final protocol, Informed Consent and other study related documents. Independently creates and manages budgets, forecasting, and monitoring for assigned studies. Oversee country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy. Provide strategic input and management of site activation activities and recruitment strategies. Oversight of study timelines to ensure the needs of the clinical development plan are met. Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted. Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring. Study team meeting management and attendance; regular review of meeting agendas and minutes. Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study. Identify, monitor and review operational risks and decisions at the study level and implementation of mitigation strategies. Oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits. Maintains cross-functional partnership to test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR. Contributes to drafting Standard Operating Procedures (SOPs) and adheres to Clinical Operations processes and SOPs to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections. Support onboarding, mentor and manage direct reports within the department. May collaborate with other functional leads to manage project related efforts. Participates in departmental quality or process improvement initiatives. Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures. Perform other duties as assigned by supervisor. Required Education, Experience and Skills: Bachelor's Degree (Life Sciences) At least 8+ years of relevant clinical operations experience in clinical trial design and conduct, with minimum of 6 years at a biotech or pharmaceutical company. Experience must include Phase 2 and 3 studies (globally recruited). Experience in more than one therapeutic area is advantageous. Pediatric experience is a plus. Experience working with various CRO partnership models, including FSP, and full-service arrangements is preferred. In-depth knowledge of clinical research operations, including GCP, FDA and/or EMEA regulations, and ICH guidelines. Excellence in project management and communication. Travel Requirements: Up to 10-20% travel, including potential to meet as a department in and around New England and to Boulder, Colorado or to clinical sites and conferences. Salary range: $140,000 - $195,000, title and salary commensurate with experience Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan. There is no deadline because the employer accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Director, Clinical Operations, the Associate Director, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. This role will lead a Phase 2 registrational clinical study with responsibilities including inspection readiness, contract negotiation, budget management, study conduct, and close-out. The Associate Director, Clinical Operations will be responsible for collaborative oversight of a cross-functional study team as well as excellent management of and partnership with CROs and vendors. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharmaceutical company and delivering high quality clinical trial results. Responsibilities: Lead and manage and provide strategic input on one or multiple clinical studies and demonstrate thorough knowledge of clinical operations' project management. Lead cross-functional clinical study team to support clinical study delivery. Evaluates, selects, and ensures appropriate oversight of CROs and other external vendors. Ensures clinical trials are executed according to scope of work, budget, timelines, and KPIs Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support corporate goals. Identify risks and propose solutions to facilitate clinical studies. Develop and demonstrates accountability for the management of study budgets through review and approval of contracts and/or work order changes; manages budget forecasting and accruals in collaboration with finance. Oversee and manage the creation, maintenance, QC and close out of TMF activities. Ensure appropriate oversight of enrollment, site activation and data collection milestones. Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms. Collaborate with the Clinical Data Manager to ensure timely and efficient database lock Participate in data review and reconciliation efforts. Mentor junior team members by delegating study related responsibilities, overseeing, and supporting development plans. Lead or co-lead department initiatives to support an expanding organization. Travel may be required (10% - 15%). Competencies Include: Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning. Excellent problem solving, communication and organization skills. Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure. Ability to work in a collaborative environment and build effective working relationships across the organization. Able to thrive in a remote/virtual environment. Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously. Qualifications: Bachelor's degree or higher in a scientific or healthcare discipline preferred with relevant experience in the biotech, pharmaceutical, or CRO industry. Minimum of 8 years of Clinical Operations experience. Extensive knowledge of ICH-GCP guidelines. Leadership experience in regulatory inspections preferred. Experience managing early through late Phase global oncology clinical trials Demonstrated cross-functional leadership fostering team spirit and team motivation. Capability to challenge status-quo using risk management approach. Additional Information: Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change. Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more. Annual Salary Range$171,000-$200,000 USD Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities. Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person. If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at ************. Thank you.

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary We are seeking an Associate Director, Clinical Operations who will be accountable for the operational management and execution of clinical trial programs (Phases II-III and later). The individual will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the oversight of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections. The Associate Director, Clinical Operations will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. This role will report to the Executive/Sr. Director, Clinical Operations. Key Responsibilities Accountable for overall management of multiple clinical trials Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs Responsible for preparing and/or presenting to executive management as delegated Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings Budget/Finance/Legal Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc Review and approve contracts, work orders and invoices prior to submission to senior management for approval Outsourcing/Procurement/Vendor Management Lead the creation/definition of the scope of work and selection process for assigned program's vendors and Contract Research Organizations (CROs) Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals Draft and/or manage Governance charters/meetings/reports with CRO Co-lead Sponsor/CRO operational meetings with CRO to ensure deliverables are on track Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, completion of Trial Master File and the following: Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to oversee scope change negotiations Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO Responsible for patient recruitment and retention plans Responsible for the set-up of all third-party vendor specifications (i.e. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB/Ethics submission prior to study start-up Clinical and Ancillary Study Supplies In conjunction with Clinical Supply, responsible for assuring sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study Responsible for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study In conjunction with CRO, responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.) Inspection Readiness Accountable for eTMF - completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files Partner with Quality organization to document Sponsor Oversight of all vendors, Data Integrity, and Risk Assessment requirements Participates and responds to Quality Assurance and/or regulatory authority inspection audits Ensures all assigned studies are always Inspection Ready Data Review/Cleaning/Management Accountable for working closely with Biometrics, Pharmacovigilance, Medical, and the CRO to participate in data review, and oversee adherence to study timelines and data quality. Oversight includes the following activities: expedited query resolution, support creation of logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. Oversight of protocol deviations/variations In conjunction with the CRO, oversee and drive the metrics on CRA source data verification Ideal Candidate BA/BS in life sciences or equivalent 8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion 2+ years' experience in Biotech industry strongly preferred Significant knowledge of pharmaceutical industry, drug development and regulatory processes Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines Work comfortably in a fast-paced, dynamic work environment and embrace change Position requires up to 25% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $180,000 - $195,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. 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. To review our privacy policy, click here 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.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Director of Clinical Research Operations provides leadership and oversight for all clinical staff supporting brick-and-mortar research sites, mobile/pop-up sites, and hybrid clinical trial models. This role ensures high-quality study execution, regulatory compliance, and strong clinical performance across a geographically dispersed workforce, including traveling CRCs and mobile clinical teams. How You'll Make An Impact Clinical Operations Management Oversight for traveling clinical staff supporting decentralized operations at events and sites. Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations. Oversee clinical workflows at sites and mobile deployments, resolving issues impacting quality, recruitment, or compliance. People Management Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff). Implement training, competency standards, and performance expectations for all clinical staff. Provide input into staffing budgets, resource planning, and clinical support models. Study Management Monitor enrollment, data quality, documentation practices, and clinical performance metrics. Partner with regulatory, medical, data, participant experience, and site operations teams to support successful trial delivery. Drive continuous improvement in clinical quality, consistency, and operational efficiency. The Expertise Required Strong knowledge of ICH-GCP, FDA regulations, and clinical trial execution. Excellent leadership, communication, and performance-management skills. Ability to thrive in dynamic environments and manage diverse clinical teams. Certifications/Licenses, Education, and Experience Bachelor's degree in a health-related field required; advanced degree preferred. 12+ years of clinical research operations experience, including leadership of multisite or dispersed clinical teams Experience overseeing CRCs, nurses, mobile clinicians, or traveling clinical staff. How We Work Together Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment. Travel: This role requires up to 20-40% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. Type of Travel Required: National Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected base salary range for this role is $120,000 - $160,000 USD per year. In addition to base salary, this role is eligible for an annual discretionary bonus as part of its overall cash compensation. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

About Us: Our purpose is to help clients exceed their financial health goals. Across the reimbursement cycle, our scalable solutions and clinical expertise help solve programmatic needs. Enabling our teams with leading technology allows analytics to guide our solutions and keeps us accountable achieving goals. We build long-term careers by investing in YOU. We seek to create an environment that cultivates your professional development and personal growth, as we believe your success is our success. JOB SUMMARY: The Director, Clinical Operations, will provide strategic leadership and oversight of the Clinical Documentation team's workflow, ensuring operational excellence, financial performance, and client satisfaction. Reporting to the Senior Director, the Director will develop and execute initiatives to optimize processes, enhance productivity, and drive continuous improvement. This role is responsible for high-level planning, resource management, performance monitoring, and cross-functional collaboration to support business objectives and maintain the highest quality standards. The Director will also serve as a key liaison between internal teams and external stakeholders to ensure alignment with company goals and client needs. ESSENTIAL DUTIES AND RESPONSIBILITIES: Note: The essential duties and responsibilities below are intended to describe the general duties and responsibilities of this position and are not intended to be an exhaustive statement of duties. This position may perform all or most of the primary duties listed below. Specific tasks, responsibilities or competencies may be documented in the Team Member's performance objectives as outlined by the Team Member's immediate Leadership Team Member. Role & Responsibilities: Serve as the primary liaison for assigned client accounts, fostering strong, trust-based relationships through consistent communication and proactive engagement. Lead strategic client meetings, including business reviews, performance updates, and planning sessions, ensuring alignment with client goals and expectations. Develop and maintain a deep understanding of client needs, business models, and strategic priorities to tailor services and solutions effectively. Drive meeting agendas and outcomes, ensuring discussions are focused, actionable, and aligned with both client and organizational objectives. Coordinate cross-functional collaboration to prepare for client meetings, ensuring all stakeholders are aligned and equipped with relevant data and insights. Report directly to the Senior Director of Clinical Documentation and provide strategic direction for the Clinical Documentation team. Lead, mentor, and develop Clinical Operations managers and team members to foster professional growth and performance excellence. Establish and implement best practices, policies, and procedures to enhance team efficiency and effectiveness. Oversee operational and financial performance, ensuring alignment with organizational objectives and client expectations. Drive innovation and process improvement to enhance departmental effectiveness and market competitiveness. Manage and optimize workflow operations, ensuring smooth execution of daily production schedules, financial goals, and quality standards. Identify operational gaps and implement corrective actions to mitigate risks and improve outcomes. Ensure regulatory compliance and adherence to industry standards across all clinical documentation functions. Oversee performance improvement programs, leveraging data-driven insights to enhance productivity and quality. Develop and present executive-level reports to clients, senior leadership, tracking key performance indicators (KPIs) and operational trends. Utilize data analytics tools (e.g., Power BI, Excel) to interpret and communicate business insights that drive informed decision-making. Ensure timely and accurate reporting of departmental performance, financial goals, and operational strategies. Serve as the primary point of contact for client escalations, ensuring prompt resolution and service excellence. Foster strong relationships with internal and external stakeholders, including clients, revenue cycle teams, and IT support. Partner with cross-functional teams to drive initiatives related to revenue cycle optimization, technology enhancements, and process automation. Oversee training and development programs to ensure team competency and alignment with evolving industry trends. Collaborate with compliance, IT, and finance departments to ensure seamless operations and adherence to corporate policies. Knowledge, Skills & Abilities: AHIMA or AAPC accreditation preferred. Minimum of five years' experience in Revenue Cycle Management. Six Sigma or related LEAN/OPEX/Process Excellence experience desirable. Strong analytical skills with expertise in Microsoft Excel, Power BI, and other data visualization tools. Strong verbal and written communication skills. Ability to work independently, exercise good judgment, and make confident decisions. Proficiency in generating, interpreting, and analyzing reports. Effective team player with the ability to collaborate and communicate effectively across departments. Travel up to 20% may be required for client meetings, team leadership engagements, site visits, and industry events. PHYSICAL DEMANDS: Note: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions as described. Regular eye-hand coordination and manual dexterity is required to operate office equipment. The ability to perform work at a computer terminal for 6-8 hours a day and function in an environment with constant interruptions is required. At times, Team Members are subject to sitting for prolonged periods. Infrequently, Team Member must be able to lift and move material weighing up to 20 lbs. Team Member may experience elevated levels of stress during periods of increased activity and with work entailing multiple deadlines. A is only intended as a guideline and is only part of the Team Member's function. The company has reviewed this job description to ensure that the essential functions and basic duties have been included. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Director, Biostatistics, provides technical leadership and operational oversight for the development of clinical strategies, the design, implementation and reporting of non-clinical, CMC, and clinical development programs and associated studies and clinical trials. He/she participates in close collaboration with the cross functional teams responsible for studies across all phases of drug development. He/she provides guidance and management to statisticians to ensure high quality and timely deliverables. He/she also supports regulatory interactions and serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally. This role reports to VP, Biostatistics, Clinical Development. Job Responsibilities Responsible for all deliverables related to statistical content. Provides guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverables. Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact. Oversees the biostatistics function in CRO's; manages scope of work and relationships with other external statistician consultants as needed. Manages resources, sets priorities, and ensures consistency and adherence to standards. Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment. Responsible for SAP, data analysis and reporting (CSR). Supports DMC charter and meeting preparation Represent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities. Supports regulatory submission and interaction, i.e, and IND/BLA filings and supports potential partnering requests. Becomes an integral member of cross-functional project teams, provides statistical input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, regulatory submissions and responses, and scientific publications and presentations. Develops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionally. Contributes to creation/maintenance of, and provides training on statistical topics, and departmental SOPs and general standardization efforts. Maintains currency of new developments in statistics, drug development, and regulatory guidance. Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities as needed. Assists with the Business Development activities at key conferences and industry meetings. Supports scientific and medical meetings, including, but not limited to, Investigator Meetings, Advisory Boards, DMC, SAB, and other interactions with Key Opinion Leaders. Presents at industry conferences representing AskBio Participates in vendor evaluation, selection, and management. Minimum Requirements Ph.D. or M.S. in Statistics or related field. Have 10+ years pharmaceutical experience in a pharmaceutical R&D environment. Knowledge of Heart Failure and Cardiovascular programs Previous experience in the preparation and submission of New Drug Applications to regulatory agencies. Strong knowledge of design of experiments, clinical trial design concepts, or CMC statistics, drug regulation, and experience in the management of the statistical function. Experience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapy preferred. Extensive experience with SAS and/or R Excellent communication skills Experience in CRO selection, contracting and management. Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at ******************. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

About Prilenia Prilenia, a private biopharmaceutical company with a highly committed and talented global team, is seeking a Vice President of Clinical Operations located in the US. Prilenia has a simple but urgent mission - to bring transformative medicines to people affected by devastating neurodegenerative diseases. Unwavering in our commitment to scientific excellence, Prilenia is developing pridopidine, a unique, oral, sigma-1 receptor (S1R) agonist investigational neuroprotective therapy for ALS and Huntington's disease (HD). Partnered with Ferrer for the commercialization and co-development of pridopidine, we plan to start two key late-stage trials to support potential approval globally in ALS and in HD in the first half of 2026. To learn more about our story and company culture, visit us at ******************** About the role We are seeking a dynamic Executive Director, Clinical Operations to join our team and lead strategic execution of global pivotal trial/s in neurodegeneration. The ideal candidate will bring extensive experience in global clinical operations, with proven track record in managing global pivotal clinical trials for biotech sponsors, and a vision to innovate and continuously improve operational standards. Experience in rare diseases required, HD and/or ALS preferred. This is a critical leadership role in a growing biotech company, suitable for a candidate who is equally comfortable driving high-level strategy and rolling up their sleeves. The position will report to the SVP, Head of Clinical Operations. Roles and Responsibilities: Provide strategic direction and operational leadership for pivotal global clinical programs, ensuring rigorous execution across regions and therapeutic areas to deliver studies on time, within budget, and to the highest quality standards Lead clinical operations aspects of clinical programs, including planning, coordination, delegation, communication and stepping into direct action as necessary to make sure goals are achieved on time and on budget. Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development. Accountable for the successful delivery and inspection readiness of complex global pivotal trial/s; own operational timelines, budget management, enrollment performance, data quality, and risk mitigation. Lead clinical study team/s including both internal and external stakeholders, fostering accountability, collaboration and operational excellence. Develop and oversee effective and efficient clinical study plans in partnership with internal and external stakeholders. Patient Recruitment: Oversee site and investigator relationships, leading the implementation of innovative patient recruitment and retention strategies, and ensuring proactive problem-solving and stakeholder engagement across diverse populations. Quality: Ensure clinical monitoring quality and ongoing adherence to established study plans and GCP requirements. Partner with Regulatory, QA and other relevant teams to continuously improve clinical SOPs. Closely collaborate with Regulatory, Quality, Safety, Data management and clinical supply to integrate cross-functional insights into operational execution and optimize delivery of clinical supplies, data, and patient safety. Build and sustain strong cross-functional relationships across diverse global teams; foster a culture of mutual accountability, collaboration, and innovation. Communicate progress, risks, and strategic insights to executive leadership and governance committees, supporting data-driven decision-making and program advancement. Qualifications and Skills: Bachelor's degree or higher in Life Sciences or related field. Minimum 10 to 15 years of clinical operations management experience in biotech companies, with at least 5 years leading global phase 3 studies and cross-functional teams Recent experience in leading the conduct of global phase 3 studies from start to completion required. Experience with rare disease required. Experience with ALS or HD highly preferred. Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures. Strong strategic thinking and project management skills, including scenario planning, risk identification and mitigation, and ability to guide complex problem resolution at scale. Expertise in patient recruitment and retention strategies at a global scale, including innovative approaches adapted for diverse populations. Strong leadership skills and advanced stakeholder management and communication skills, including influencing executive leadership, cross-functional partners, and external collaborators. Displays exceptional situational awareness in communication-adapts tone, content, and level of detail to suit the audience, from executives to technical teams. Demonstrates sound judgement in deciding what details to share or escalate. Demonstrated ability to manage CROs (and other vendors) to meet or exceed KPIs tied to corporate goals and hold them accountable if they fall behind. Proficiency with clinical research technologies and platforms (EDC, eTMF, IWRS, CTMS, etc.), plus strong skills in Microsoft Office and data analysis tools. Willingness and ability to travel (domestic & international) and operate flexibly in virtual teams and global time zones. Location/Time Zones: • This is a full-time, remote position based in the US, eastern time zone strongly preferred. • Expected domestic and international travel up to 30%. • Flexible schedule with interactions across North America, Europe and Israel time zones. Prilenia operates across the United States, Canada, Europe and Israel, is incorporated in the Netherlands and backed by leading life sciences investors. We are a highly flexible organization that is mostly remote and encourages team members to work in the ways that make them most effective, with a focus on our common goals and getting the job done. Prilenia is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are dedicated to fostering a diverse, inclusive, and welcoming workplace for all.

Our client, a dynamic technology forward national law firm with an innovative structure has exclusively retained Solutus Legal Search to assist the firm in its search for a Legal Director. Our client believes everyone, everywhere, deserves access to remarkable legal care and its innovative structure facilitates growth while preserving excellent representation. Our client has reimagined legal services to provide people with an easier, more transparent, and more human experience when they need it the most. Reporting to the firm's Principal Attorney, the Legal Director will be responsible for managing the day-to-day operations of the firm, including working closely with and leading a team of Managing Attorneys in the firm's offices, budgeting and finance, and developing and managing systems and related initiatives to enable the firm's attorneys to deliver best in class legal services across the states in which the firm represents clients. This position is fully remote.What You Will Do Work with the firm's Principal Attorney to identify and lead a strategic operational plan and related initiatives and opportunities to optimize the firm's legal strategies and operations Work with cross-functional business teams and business partners to understand business needs and translate and align those needs into key performance indicators, plans, and practices for the firm Serve as point-person with Managing Attorneys to provide advice and decisions on case management escalations and risk management scenarios, and address any concerns regarding the quality of performance and service Ensure that the firm's practices are in compliance with all applicable laws, regulations, and ethical standards Monitor and ensure that the firm's lawyers and support staff are in compliance with their obligations under state governing regulations and rules Work with and lead the team of Managing Attorneys to develop operational metrics, processes, and policies to improve the effectiveness and efficiency of their practice areas Key Qualifications J.D. from an ABA-accredited law school Licensed to practice law in a US jurisdiction and eligible to practice in your state of residence - NY, CA, GA, TX, or FL preferred 7+ years of experience with experience in each of the following: litigation, law firm operations and legal operations Experience working inside a high-growth software or tech company, preferably in legal or strategic operations is a plus, but not required. Skills and Capabilities Strategic legal expertise and leadership: Experience leading legal operations strategy and teams, including leading strategic cross-functional initiatives aligned to a strategic vision set of business goals to maximize performance of the firm Strategy formulation and executional excellence: Experience formulating and driving sophisticated, organization-wide initiatives, including the ability to design and lead small and large-scale projects with multiple contending priorities while partnering with leaders for prioritization and implementation Interpersonal relationships: Experience building personal credibility and impact through active listening, influencing others, leading people, and communicating clearly, including experience partnering with senior leaders, driving consensus, and landing clear decisions Data analytics: Experience designing and tracking metrics to measure the quality and success of programs, as well as designing effective presentations to share data insights with leadership Situational adaptability: Agility to work and drive progress in a fast-paced environment and not be afraid to pivot to meet the most current needs of the business or the legal team Communication: Demonstrated ability to effectively collaborate and communicate verbally and in writing, building compelling presentations and effectively managing multiple stakeholder groups People leadership: Strong people leadership capabilities including ability to manage change, influence, develop, and coach senior level professionals Compensation consists of an annual base salary range of $235,000 to $250,000 plus target bonus target and a 5% 401k match. The total compensation package will vary and depend on the candidate's level of seniority, number of years of directly relevant experience, and location. Some travel among offices is anticipated. Solutus has been selected as the exclusive representative on this desirable search. Resumes submitted directed to our client will be forwarded to Solutus for review and evaluation. Ref. # 878-SLS

The Role: Moderna is seeking a Director of Clinical Operations to manage oncology programs which may consist of one or more studies. This is a clinical operations program management role. This position will be responsible for initiating and leading clinical programs, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations, Therapeutics and Oncology with a focus on oncology. This position will work collaboratively across the oncology development and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. Here's What You'll Do: Accountable for delivery of assigned clinical program budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders Oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs Support the selection, oversight, and management of CROs and other vendors Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders Perform and document study level Sponsor Oversight of outsourced clinical activities Communicate study-status, cost and issues to ensure timely decision-making by senior management Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna Support program level deliverables/activities Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff. Strive for continuous improvement and more efficient ways of working in clinical development Act as a role model for Moderna's values Here's What You'll Bring to the Table: Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred. Robust experience in oncology required. Late-stage/phase 3 experience required. Experience in immuno-oncology is desirable but not required. Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc. Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc. Experience in GCP inspections/audits Outstanding verbal and written communication skills, in addition to excellent organizational skills Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry Resilient, Creative, capable problem-solver Excellent organizational skills and ability to work independently Experience in establishing and maintaining relationships with key opinion leaders Some travel required Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 -

Opportunity We are a clinical-stage biopharmaceutical company specializing in the development of novel long-acting therapeutics for obesity and related metabolic disorders. Our team invents, develops, and uses novel drug delivery technologies that enable controlled, predictable, and sustained release of drugs over weeks or months. Our approach has the potential to enhance pharmacokinetics, efficacy, and safety while significantly reducing dosing frequency. Position The Director/Senior Director, Clinical Operations will be responsible for the management, oversight, and hands-on execution of clinical studies, ensuring they are completed according to timelines, budgets, and regulatory quality standards. Reporting to the Chief Medical Officer, the incumbent will serve as a key functional leader and subject matter expert, working cross-functionally with other functional experts to advance preclinical candidates into and through clinical development, with an initial focus on first-in-human studies. Building on prior industry experience and solid knowledge of IND/clinical development processes, the candidate will work independently to establish and oversee all aspects of clinical operations, including CRO/vendor selection and management, establishment of study budgets and timelines, site selection and interaction with study personal, as well as development of study-related documents, to generate high quality clinical data in keeping with applicable regulatory/industry standards. Roles and Responsibilites Responsible for the clinical operation function at the company and for representing clinical operations in cross-functional program teams, working closely with team leaders and other functional area subject matter experts Accountable for the strategic planning and operational execution of clinical trials, ensuring they are conducted within agreed upon timelines, budgets, and regulatory quality standards. Actively lead and/or participate in the development of clinical documents, including but not limited to protocols, ICFs, study manuals, investigator brochures, and clinical study reports. Responsible for maintaining constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones. Actively lead the selection, management, and performance of study-related CROs, vendors, and external consultants. Accountable for the management of clinical budgets. Develop and maintain strong collaboration and communication with internal and external stakeholders, including regular communication of study-related metrics / KPIs to executive management and cross-functional study teams. Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices. Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training, and other tools to ensure compliance with FDA Regulations Lead responses to any audits as required (site, internal file, process, and regulatory agencies) Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials, including the evaluation and implementation of clinical technologies (e.g., EDC, eTMF, CTMS) appropriate for the company's stage of growth. Collaborate closely with CMC and Supply Chain teams to ensure clinical trial material (CTM) availability, stability, and proper handling/administration at clinical sites. Provide accurate, current updates to executive management and program teams regarding the status of clinical trials. Qualifications Bachelor's degree or higher in a relevant field, preferably related to biological or life sciences. Higher/professional degree a plus. 10+ years Clinical Operations experience. Strong experience in the set-up and management of domestic and international early and late phase clinical trials, either directly or via CRO/vendor management. Prior experience in metabolic, endocrine, or obesity clinical trials is highly desirable. Experience managing multiple projects and priorities. Strong working knowledge of GCP/ICH guidelines. Experience developing and managing departmental and study budgets and timelines. Strong interpersonal skills with demonstrated ability to effectively work with internal and external cross-functional groups. Extensive knowledge of drug development functions relevant to clinical trial conduct (e.g., data management, biostatistics, pharmacovigilance, CMC/supply chain management, etc.). Demonstrated ability to collaborate effectively in cross-functional teams and function effectively in a lean, fast-paced biotech environment, balancing strategic leadership with daily tactical execution. Excellent written, communication, and interpersonal skills, and demonstrated cultural agility. Ability and willingness to travel domestically and internationally as needed, such as for study site visits. This is a remote position. Occasional travel to the Company's offices in Emeryville is expected/required. We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don't hesitate to apply!ProLynx, Inc. is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions.

Job Description If you are not local to Miami, let's discuss how to get you there! This is a newly created role at an amazing, top clinical research site located in Miami, FL About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. About the Role: We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision. Responsibilities: Lead and mentor the clinical operations team to promote a collaborative and efficient environment. Ensure protocol compliance and maintain high-quality standards across studies. Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies. Oversee human resources functions, including staff evaluations, recruitment, and training. Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies. Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators. Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation. Conduct study closeout procedures. Perform additional duties as needed to adapt to the evolving needs of CPMI. Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP Minimum Qualifications: Bachelor's degree in a scientific or healthcare-related field 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role. Strong understanding of FDA, ICH, and GCP regulations and guidelines Strong communication, organizational, and leadership skills. Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software. In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out Experience managing and mentoring a team of clinical operations professionals Preferred Qualifications: Phase I or early phase experience Bi-lingual in English and Spanish Benefits Overview: Our comprehensive benefits package includes: Health insurance Dental & Vision Insurance Matching 401k Retirement Plan Paid Time Off (PTO)

(TCT): Total Care Therapy (TCT) is a therapist-owned and operated company specializing in Physical, Occupational, and Speech Therapy services in assisted and independent living settings. Our mission is to empower individuals to regain their independence through compassionate and high-quality care. At TCT, we cultivate a culture that prioritizes flexibility, personal and professional growth, and a collaborative team spirit. Our commitment to fostering a positive and inclusive culture ensures that every member of our team feels valued and motivated to make a meaningful impact on the lives of those we serve. About the Role: We are seeking a compassionate and motivated Physical Therapist (PT) to join our dedicated team. In this role, you will provide patient-centered care in assisted living settings, helping residents regain independence, enhance daily functioning, and improve their quality of life. Director of Rehabilitation Responsibilities: As a key leader in your building, you will: Act as the main liaison between leadership and the facility. Oversee staff performance and support professional development. Manage administrative and operational tasks across therapy services. Coordinate meetings, trainings, and events for staff and residents. Maintain communication with residents, families, and leadership. Requirements for the Physical Therapist Role Current, valid Ohio Physical Therapy license Must hold active CPR and Basic Life Support (BLS) certification. Reliable Transportation A valid driver's license and auto insurance are required for reliable transportation. Previous experience in home health care is preferred. Why Join TCT? Competitive Pay & Flexibility: Enjoy competitive compensation and a flexible work schedule tailored to your needs. Career Growth: Be part of a company that supports ongoing professional development and advancement opportunities. Impactful Work: Make a meaningful difference in the lives of individuals as they work to regain mobility and independence. Team Environment: Join a supportive team culture where your contributions are valued and appreciated. Join our team as an Physical Therapist where you can make a meaningful impact on the lives of individuals seeking to regain their mobility and independence!