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  • Senior Director, Clinical Operations (TMF & CTMS)

    Summit Therapeutics Sub, Inc.

    Remote director of clinical education job

    Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Careers At Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. Senior Director, Clinical Operations (TMF & CTMS) Location: On-site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami, FL office. About Summit: Ivonescimab, also known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit's license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: The Senior Director, Clinical Operations (TMF) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions. The individual leads transformative initiatives that create effective and efficient processes that meet high compliance standards; collaborating across Development (focus on Clinical Operations); serving as a change manager to implement new systems and practices that support the organization as we continue to grow. The Senior Director, Clinical Operations (TMF) is an effective clinical operations team leader accountable for talent acquisition, development, management, and evaluation of team members in his/her/their group. This includes responsibility for the ‘What' (delivery to performance goals) and the ‘How' (deliver consistent with Summit Therapeutics core values). The individual is also a member of the Clinical Operations extended leadership team and as such supports and influences the direction of the Clinical Operations extended team. The individual collaborates with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients. Role and Responsibilities: Develop, implement, and oversee the CTMS and TMF systems and related processes Lead the oversite of TMF and CTMS vendors, contractors, and cross-functional teams provide leadership and development to existing TMF employees and lead by example by demonstrating our core values Define, eexecute, and communicate the strategic vision for TMF and CTMS to maximize end user focus and engagement Partner with key internal and external stakeholders to remediate risks and manage emerging issues. Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards Provide business level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations Lead a team of TMF and CTMs colleagues and ensure their continuous development Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for TMF and CTMS Provide strategic leadership, insight, and guidance as an active member of the Clinical Operations Extended Leadership Team (XLT) Ensure inspection ready TMF and CTMS and provide expert support for audits and inspections Instill a culture of continuous improvement; acts as a change champion and effectively leads change Other key assignments including ad hoc and stretch assignments in support of Clinical Operations and clinical trial execution Travel on assignment (~25%) All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree (e.g. BA, BS or equivalent) required; preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline is preferred Minimum of 12+ years of strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF, CTMS) preferred A minimum of 5+ years of experience in people management/leadership required Proven line and functional manager experience, able to effectively lead teams including regional (multi-country) and remote-based staff Experience in Phase III execution of clinical trials; Oncology trials preferred Previous regulatory inspection experience preferred Strong comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines Significant vendor oversight experience including contracts and budget management preferred The pay range for this role is $230,000-$250,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit. #J-18808-Ljbffr
    $230k-250k yearly 4d ago
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  • Associate Medical Director

    National Staffing Solutions 4.2company rating

    Director of clinical education job in Columbus, OH

    Permanent Associate Medical Director Board Certified in Family Medicine / Internal Medicine FQHC Setting What we Offer: Schedule: M- F 8am to 5pm, No Weekends Competitive Pay: $250k to $270k. depends on experience Sign On Bonus: $30,000 Full Benefits Package - Medical, dental, vision, disability & life insurance. 401(k). What the Associate Medical Director will Do: 80% Clinical / 20% Administration Supervise and coach fellow providers in how to provide excellent primary care / urgent care and community care This is a FQHC setting must be comfortable with Community Medicine Partake in leadership meeting and also act as an ambassador to community based organizations, hospitals, and payers Requirements of the Associate Medical Director: 5+ Years clinical experience / Administrative leadership experience needed Must have 2 -3 recent years experience in primary care medicine Active and unrestricted medical or nursing license in the state required Background in working for a clinic or community based inpatient setting a plus Must be ok prescribing opioids
    $250k-270k yearly 4d ago
  • Director, Medical Affairs (Remote)

    Stryker Corporation 4.7company rating

    Remote director of clinical education job

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Abbott Heart Failure (HF) delivers devices for patients living with heart failure in the areas of hemodynamic monitoring and mechanical circulatory support. Medical affairs of Abbott HF is seeking to hire a director who will join a team of medical specialist dedicated to all medical aspects of safe and effective device heart failure treatment. The director will report to the Chief Medical Officer. The Director of Medical Affairs will provide daily business operations support related to product development and clinical research, product quality, compliance, commercial/marketing activities and customer interactions. The director assists the Chief Medical Officer in being medical representative of Abbott HF to external regulatory agencies and professional societies. What You'll Work On The Medical Director Develops medical opinions, medical platform documents and Health Hazard Assessments. Provides medical input for promotional and commercial activities as requested. Serves as medical representative on Risk Evaluation teams. Assists investigation teams by providing medical input as needed. Responsible for updating medical affairs procedural documents and submitting change requests when needed. Provides medical support for MDR reporting when needed. Provides initial medical input for quality/regulatory customer communications, technical bulletins and quality directives. Engages with direct customer interactions with medical content as needed. Regionally responsible for Investigator Initiated Study and Research Grant programs. Provides input or content to professional education activities. Responsible for engaging in and documenting off-label discussions. Assists the Chief Medical Officer in KOL and professional society engagement. Provides medical input to new product development An MD is strongly preferred for this role, but a PhD in a relevant area would be considered. A minimum of 5 years of clinical experience including in CV medicine would be clinical research, including interpretation and presentation would be expected. Strong presentation skills required. The role is remote (US-based) Up to 70 % travel should be expected. APPLY NOW Enjoy a competitive base salary plus exciting bonus opportunities and long-term incentives designed to recognize your success. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal #J-18808-Ljbffr
    $221k-314k yearly est. 5d ago
  • Remote Liver Medical Affairs Director - Regional Expert

    Gilead Sciences, Inc. 4.5company rating

    Remote director of clinical education job

    A leading biopharmaceutical company is seeking a Senior Director for Medical Affairs to lead initiatives focused on liver diseases. The ideal candidate should have substantial clinical experience in hepatology and a commitment to scientific excellence. This remote position requires strategic collaboration and contributions to research efforts to improve liver care outcomes. Strong leadership and communication skills are essential for engaging diverse healthcare professionals in clinical discussions. #J-18808-Ljbffr
    $235k-330k yearly est. 1d ago
  • Director of Nursing (DON)

    Jag Healthcare 4.3company rating

    Director of clinical education job in Marion, OH

    JAG Healthcare Marion is now scheduling RN/DON interviews as we are searching for our next long-term Director of Nursing (DON). JAG Healthcare Marion is seeking a strong, energetic Director of Nursing (DON) to work alongside their long-time Administrator to help maintain the excellent care culture that is established there. The Director of Nursing (DON) should be a compassionate RN who has at least five years of experience as a Director of Nursing or in a comparable position. Recognizing that there is much opportunity in our healthcare employment market for potential applicants, we are seeking candidates interested in employment stability, flexible scheduling, and the desire to secure a long-term employment opportunity. Being a smaller facility, there is a balance in the workload and exceptional patient care ratios. Leadership staff are expected to lead by example and be team-oriented to ensure the highest level of quality care and service can be delivered to our residents. JAG Healthcare Marion has only 45 beds, giving it a homelike feel for our residents. This quaint environment also provides our nurses the opportunity to spend meaningful time with their residents without rushing from one room to the next. This is one of the most common positive comments that we hear from nurses coming from larger healthcare facilities. If you are looking for a rewarding job as a Director of Nursing (DON) that allows you to build meaningful connections with residents while improving their quality of life, this job could be for you!. Skills & Responsibilities (include but not limited to): Direct, oversee, coordinate & evaluate nursing care services provided to the residents. Emphasis on education and staff development to grow and develop the nursing team Ensuring compliance with all State & Federal guidelines. Ensuring all confidentiality and privacy rights of residents are observed & enforced. Overseeing State Survey complaints, investigations, and resolutions. Develop and enforce policies aiming for legal compliance and high-quality standards. Develop objectives and long-term goals for the department. Guide staffing procedures. Excellent ability to lead and develop personnel. Willingness for continual education to keep up with changing standards in nursing administration. Exceptional communication and problem-solving skills, with a focus on customer service. Strong focus on Quality Assurance and Performance Improvement Team-oriented with the ability to work in a collaborative interdisciplinary setting Requirements for the position include: Licensed as a Registered Nurse (RN) in the State of Ohio and in good standing with the Board of Nursing. Must be familiar with and be able to follow all established Federal, State and Local rules, regulations, and guidelines. Must understand and be able to implement and follow the facility policy/procedure. Proven ability to lead a clinical team to successful clinical outcomes. Minimum of 5 years DON experience, or comparable position (required) Minimum of 5 years of acute care, long-term care, or geriatric supervisor and management experience in a Medicaid/Medicare certified facility (required). Experience working with cognitive deficits and behavioral health care (plus). Successful completion of the Infection Preventionist Training (preferred, but willing to assist with certification) Strong focus on inventory and supply chain management At JAG Healthcare, we offer a homelike family family-oriented atmosphere, striving to create a lifetime of balance for our residents, employees, and the communities in which we serve .
    $63k-79k yearly est. 5d ago
  • Senior Director, Clinical Operations

    IMVT Corporation

    Remote director of clinical education job

    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.
    $275k-285k yearly Auto-Apply 45d ago
  • Senior Manager/Associate Director, Clinical Operations (EDG-2026002)

    Edgewise Therapeutics 4.0company rating

    Remote director of clinical education job

    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.
    $140k-195k yearly 29d ago
  • Associate Director, Clinical Operations

    Apogee Therapeutics

    Remote director of clinical education job

    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.
    $180k-195k yearly Auto-Apply 3d ago
  • Director, Clinical Research Operations

    Care Access 4.3company rating

    Remote director of clinical education job

    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: ********************************
    $120k-160k yearly Auto-Apply 4d ago
  • Director of Clinical Operations/Ambulatory Cardiac Monitoring (IDTF)

    Wearlinq

    Remote director of clinical education job

    Clinical Director IDTF WearLinq is a fast-growing Series A funded provider of digital healthcare solutions with a focus on outpatient electrocardiogram (ECG) monitoring. The unique WearLinq system is designed to elevate the standard of remote cardiac monitoring by the enhanced detection of heart rhythm disorders and effectively reducing overall healthcare costs. The Wearlinq platform (or system) includes the first FDA cleared 6-lead cardiac monitor with multidimensional views of the heart for electrocardiogram (ECG) studies. Wearlinq has an Independent Diagnostic Testing Facility (“IDTF”) with clinical operations in Rockville, MD. Position Summary The Director of Clinical Operations/Ambulatory Cardiac Monitoring is responsible for the leadership, strategic direction, and operational oversight of the Independent Diagnostic Testing Facility (IDTF) cardiac monitoring division. This includes management of certified cardiac monitoring technicians (CCT/CRAT/CRAT-C), ensuring high-quality arrhythmia analysis, compliance with CMS and IDTF regulatory standards, and optimizing workflow efficiency to support growth and clinical excellence. This role partners closely with the VP of Clinical Services to elevate clinical quality, customer satisfaction, technician performance, and the integrity of all MCT, CEM and Holter monitoring services. Key Responsibilities Leadership & Workforce Management Directly oversee and manage a team of certified cardiac monitoring technicians, leads, and supervisors. Ensure appropriate staffing levels to support 24/7/365 monitoring operations. Hire, train, coach, and evaluate team members to maintain high competency in ECG interpretation and clinical workflow standards. Foster a culture of accountability, clinical excellence, and continuous improvement. Clinical Quality Oversight Maintain responsibility for the accuracy and integrity of arrhythmia detection, event analysis, and end-of-study report generation. Ensure adherence to IDTF standards, CMS guidelines, and company clinical protocols. Oversee quality assurance audits and participate in root-cause analysis, corrective action, and ongoing quality improvement initiatives. Collaborate with Clinical Education teams to update training materials, competencies, and certification standards. Operational Excellence Develop and optimize workflows to ensure timely processing of MCT live monitoring, auto-trigger events, daily reports, priority alerts, and end-of-study reports. Ensure the monitoring center meets performance metrics including: Report turnaround times Accuracy and completeness of event documentation Appropriate triage and provider notifications Compliance with escalation protocols Identify operational gaps and implement process improvements to increase efficiency and consistency. Compliance & Regulatory Management Ensure full adherence to federal and state IDTF regulations, Medicare requirements, and payer documentation standards. Maintain documentation readiness for audits (CMS, Joint Commission, payers, internal compliance). Oversee technician compliance with: HIPAA Patient identity verification Reporting standards Documentation policies Cross-Functional Collaboration Partner with VP of Clinical Services and internal leadership on strategic initiatives, workflow improvements, and technology enhancements. Work closely with Customer Service, Sales, Account Management, Product, and Engineering to support product improvements and customer escalations. Provide technical and clinical expertise during customer issue investigations or escalations involving monitoring data, reports, or technician processes. Data, Analytics & Reporting Monitor key KPIs and deliver regular performance reports to leadership. Analyze trends in event volumes, report output, error rates, and technician productivity. Provide insights and recommendations for staffing models, workflow optimization, and technology improvements. Technology & Platform Utilization Serve as a subject matter expert for monitoring platforms, ECG analysis software, and reporting tools. Collaborate with Product and Engineering on feature updates, system improvements, and clinical workflow enhancements. Ensure technicians are fully trained on all platform upgrades or new device integrations. Qualifications Required RN, EP/Cardiology Specialist, CCT, CRAT, or similar clinical background. 5+ years of experience in ambulatory cardiac monitoring, IDTF operations, cardiology, electrophysiology, or related field. 3+ years of leadership or supervisory experience in a clinical or technical monitoring environment. Strong knowledge of arrhythmia identification, workflow protocols, and clinical report building. Deep familiarity with CMS, IDTF regulatory standards, and cardiac monitoring documentation requirements. Preferred Bachelor's degree or equivalent Experience managing 24/7 monitoring operations. Prior involvement in scaling IDTF or high-volume monitoring centers. Familiarity with MCT, Holter, Event, and extended-wear patch monitoring platforms. Experience with quality assurance, audits, and compliance programs. Benefits at WearLinq Medical, Vision and Dental Insurance - Covered 100% for Employees Unlimited Time Off Remote based team throughout the US Competitive salary and equity options Opportunity to work at the forefront of healthcare innovation
    $89k-140k yearly est. Auto-Apply 5d ago
  • Director, Clinical Operations

    Corrohealth

    Remote director of clinical education job

    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.
    $104k-162k yearly est. Auto-Apply 40d ago
  • Director Biostatistics, Clinical Operations

    Askbio Asklepios Biopharmaceutical, Inc.

    Remote director of clinical education job

    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.
    $104k-162k yearly est. Auto-Apply 60d+ ago
  • Executive Director, Clinical Operations - East Coast, US

    Prilenia

    Remote director of clinical education job

    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.
    $104k-162k yearly est. Auto-Apply 60d+ ago
  • Director of Clinical Operations

    Scene

    Remote director of clinical education job

    Reports to: Vice President of Operations Scene Health is on a mission to solve medication non-adherence. We're a diverse team of clinicians, technologists, and public health enthusiasts committed to building high-impact, patient-centered solutions. The Director of Clinical Operations will be the driving force behind building, managing, and scaling a high-performing clinical team that supports patients with infectious and chronic conditions through our digital medication engagement platform. This role centers on people leadership, operational discipline, and accountability-ensuring the clinical team delivers consistently excellent care at scale. About the Role You will oversee the strategy, structure, and day-to-day operations of Scene's clinical programs. Your primary focus will be leading a growing team of nurses, pharmacists, health coaches, and clinical support staff, setting clear standards for performance, ensuring adherence to protocols, and fostering a culture of excellence, accountability, and continuous improvement. This hands-on leadership role blends operational rigor with compassionate team development to drive excellence and scalability of our program, which encompasses Video-Directly Observed Therapy, video-based medication engagement and health coaching, pharmacy services, including medication therapy management, and comprehensive medication reviews. Key Responsibilities Strategic Leadership & Standards Setting * Develop and articulate a clear vision for clinical operations that aligns with organizational goals for quality, patient outcomes, and operational performance. * Lead the strategy and execution for Scene's clinical operations, aligning clinical programs with enterprise goals for patient outcomes, quality metrics, and operational efficiency. * Establish and enforce clinical standards, protocols, and workflows to ensure consistent, compliant, high-quality care delivery across all programs. * Translate strategic goals into actionable operating plans, team structures, and performance expectations. * Collaborate closely with internal stakeholders (e.g., Enrollment, Customer Success, Growth, Product) to ensure clinical programs are launched, scaled, and executed with operational excellence. * Partner with Product and Experience teams to recommend enhancements that improve team workflows and patient engagement. * Represent the team and the company at external meetings or events. People Leadership & Performance Management * Lead, mentor, and grow a diverse clinical team-including nurses, pharmacists, health coaches, and support staff-while fostering a mission-driven, patient-first culture. * Build and implement performance management frameworks, including clear role definitions, KPIs, and development plan, while holding the team accountable to meet standards. * Provide regular, structured feedback and coaching to ensure individuals and teams are meeting expectations. * Partner with supervisor and human resources to design and execute training, hiring strategies, competency assessments, and succession plans that support team growth and retention. * Oversee staffing models, scheduling, and team coverage to ensure service levels and performance goals are consistently met. Operational Discipline & Quality Assurance * Implement and maintain rigorous QA programs to ensure adherence to protocols, regulatory compliance, and internal quality standards. * Monitor performance in real time; identify gaps and implement corrective action plans quickly and consistently. * Standardize SOPs, escalation pathways, and workflows to create clarity and reduce variability in clinical delivery. * Ensure accurate and timely documentation of services to support billing, reporting, and compliance. * Use operational platforms (e.g., Salesforce, Talkdesk, Scene's platform) to monitor performance, track KPIs, and inform decision-making. * Regularly analyze performance data to identify trends, opportunities, and areas needing intervention. About You * You are a strong people manager who builds high-performing teams through structure, clarity, and accountability. * You thrive on setting standards, coaching to excellence, and holding teams to clear expectations. * You are operationally disciplined and comfortable making tough decisions when needed. * You are passionate about creating meaningful patient experiences and empowering your team to deliver them. * You are comfortable working in a fast-paced, mission-driven environment, with the ability to balance strategic thinking and hands-on execution. Required Qualifications * Clinical background (e.g., Nurse, Pharmacist, Licensed Clinical Social Worker, or equivalent). * 10+ years of progressive leadership experience managing clinical teams, including remote teams. * Proven success in building team structures, implementing performance frameworks, and managing metrics. * Experience developing and enforcing clinical protocols and QA programs. * Strong data and technology fluency; experience using platforms to manage operations and track performance. * Adept in using clinical platforms and working in a tech environment * Bachelor's degree required. Preferred Qualifications * Experience managing digital health programs or working in a health startup. * Experience partnering with hospitals or health plans on quality improvement initiatives. * Advanced degree preferred, including but not limited to MBA, MPH, MScN. * Spanish language capabilities Why Join Us? Benefits & Perks * Competitive salary range * Paid vacation, paid sick leave, plus paid holidays * Health, dental, vision, short and long-term disability * 401K retirement savings plan The biggest perk is that you will be working on a game-changing solution in healthcare with people who are talented, motivated, and passionate. Scene has impacted thousands of lives to date, but you will be integral in scaling that impact. * Work remotely while making a tangible impact on patients' lives. * Be part of an innovative healthcare solution addressing a $500B medication adherence challenge. * Collaborate with passionate professionals across healthcare, technology, and public health sectors. * Professional development and growth opportunities within a rapidly scaling company. If you are a compassionate, tech-savvy healthcare professional with a passion for patient engagement and medication adherence, we want to hear from you! Apply today to join us in transforming healthcare and empowering patients toward better health outcomes. We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas at this time.
    $91k-142k yearly est. 60d+ ago
  • Director of Clinical Operations

    Scene Health

    Remote director of clinical education job

    Reports to: Vice President of Operations Scene Health is on a mission to solve medication non-adherence. We're a diverse team of clinicians, technologists, and public health enthusiasts committed to building high-impact, patient-centered solutions. The Director of Clinical Operations will be the driving force behind building, managing, and scaling a high-performing clinical team that supports patients with infectious and chronic conditions through our digital medication engagement platform. This role centers on people leadership, operational discipline, and accountability-ensuring the clinical team delivers consistently excellent care at scale. About the Role You will oversee the strategy, structure, and day-to-day operations of Scene's clinical programs. Your primary focus will be leading a growing team of nurses, pharmacists, health coaches, and clinical support staff, setting clear standards for performance, ensuring adherence to protocols, and fostering a culture of excellence, accountability, and continuous improvement. This hands-on leadership role blends operational rigor with compassionate team development to drive excellence and scalability of our program, which encompasses Video-Directly Observed Therapy, video-based medication engagement and health coaching, pharmacy services, including medication therapy management, and comprehensive medication reviews. Key Responsibilities Strategic Leadership & Standards Setting Develop and articulate a clear vision for clinical operations that aligns with organizational goals for quality, patient outcomes, and operational performance. Lead the strategy and execution for Scene's clinical operations, aligning clinical programs with enterprise goals for patient outcomes, quality metrics, and operational efficiency. Establish and enforce clinical standards, protocols, and workflows to ensure consistent, compliant, high-quality care delivery across all programs. Translate strategic goals into actionable operating plans, team structures, and performance expectations. Collaborate closely with internal stakeholders (e.g., Enrollment, Customer Success, Growth, Product) to ensure clinical programs are launched, scaled, and executed with operational excellence. Partner with Product and Experience teams to recommend enhancements that improve team workflows and patient engagement. Represent the team and the company at external meetings or events. People Leadership & Performance Management Lead, mentor, and grow a diverse clinical team-including nurses, pharmacists, health coaches, and support staff-while fostering a mission-driven, patient-first culture. Build and implement performance management frameworks, including clear role definitions, KPIs, and development plan, while holding the team accountable to meet standards. Provide regular, structured feedback and coaching to ensure individuals and teams are meeting expectations. Partner with supervisor and human resources to design and execute training, hiring strategies, competency assessments, and succession plans that support team growth and retention. Oversee staffing models, scheduling, and team coverage to ensure service levels and performance goals are consistently met. Operational Discipline & Quality Assurance Implement and maintain rigorous QA programs to ensure adherence to protocols, regulatory compliance, and internal quality standards. Monitor performance in real time; identify gaps and implement corrective action plans quickly and consistently. Standardize SOPs, escalation pathways, and workflows to create clarity and reduce variability in clinical delivery. Ensure accurate and timely documentation of services to support billing, reporting, and compliance. Use operational platforms (e.g., Salesforce, Talkdesk, Scene's platform) to monitor performance, track KPIs, and inform decision-making. Regularly analyze performance data to identify trends, opportunities, and areas needing intervention. About You You are a strong people manager who builds high-performing teams through structure, clarity, and accountability. You thrive on setting standards, coaching to excellence, and holding teams to clear expectations. You are operationally disciplined and comfortable making tough decisions when needed. You are passionate about creating meaningful patient experiences and empowering your team to deliver them. You are comfortable working in a fast-paced, mission-driven environment, with the ability to balance strategic thinking and hands-on execution. Required Qualifications Clinical background (e.g., Nurse, Pharmacist, Licensed Clinical Social Worker, or equivalent). 10+ years of progressive leadership experience managing clinical teams, including remote teams. Proven success in building team structures, implementing performance frameworks, and managing metrics. Experience developing and enforcing clinical protocols and QA programs. Strong data and technology fluency; experience using platforms to manage operations and track performance. Adept in using clinical platforms and working in a tech environment Bachelor's degree required. Preferred Qualifications Experience managing digital health programs or working in a health startup. Experience partnering with hospitals or health plans on quality improvement initiatives. Advanced degree preferred, including but not limited to MBA, MPH, MScN. Spanish language capabilities Why Join Us? Benefits & Perks Competitive salary range Paid vacation, paid sick leave, plus paid holidays Health, dental, vision, short and long-term disability 401K retirement savings plan The biggest perk is that you will be working on a game-changing solution in healthcare with people who are talented, motivated, and passionate. Scene has impacted thousands of lives to date, but you will be integral in scaling that impact. Work remotely while making a tangible impact on patients' lives. Be part of an innovative healthcare solution addressing a $500B medication adherence challenge. Collaborate with passionate professionals across healthcare, technology, and public health sectors. Professional development and growth opportunities within a rapidly scaling company. If you are a compassionate, tech-savvy healthcare professional with a passion for patient engagement and medication adherence, we want to hear from you! Apply today to join us in transforming healthcare and empowering patients toward better health outcomes. We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas at this time.
    $91k-142k yearly est. Auto-Apply 60d+ ago
  • Tax Staff through Director--Major Corporation-Fully Remote!

    Tax Staffing Solutions

    Remote director of clinical education job

    We are seeking to rebuild our in-house tax department at levels since we relocated to Houston. Resume to: taxstaffing@gmail.com Duties include: Prepare federal and state (current and deferred) tax returns and provisions in accordance with ASC 740. analysis of effective tax rate, the reconciliation and analytical review of the tax accounts, and maintenance of deferred taxes inventory. Streamlined ASC 740 tax provision, and tax compliance processes by implementing OneSource Tax Provision software and integrating it with OneSource Income Tax software, which led to efficiency in financial reporting, reduction in professional service costs, and increase net profit. Kept track of tax software upgrade by keeping abreast of latest version update, determine how updates would improve the tax processes, and made system upgrade recommendation to superior if warranted. Drafted documentation of testing of internal controls under Sarbanes-Oxley 404 and update tax processes and controls.C Coordinate with outside Big 4 and law firms as well as other third parties. Led tax compliance efforts, including preparation of quarterly estimates and extension income/franchise tax payment calculations. Provided assistance in the information gathering process for the ongoing IRS and state tax audits. Conducted tax-related research to minimize company's federal and state income tax liability. Research and planning. Involvement with adminitrative and budge matters Attend tax seminars and conferences
    $62k-101k yearly est. 60d+ ago
  • Director/Mgr. of Clinical Research Ops-Onsite in Miami, FL

    Evolution Research Group

    Director of clinical education job in Columbus, OH

    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)
    $83k-130k yearly est. 2d ago
  • CCO In Training, Director of Clinical Services

    Pennant Group

    Remote director of clinical education job

    This opportunity will be on-site in Arizona, Nevada, Utah or Colorado. Cornerstone, part of The Pennant Group family, is currently seeking entrepreneurial-minded leaders with proven results in building and leading exceptional clinical teams - and has a passion for the home health, hospice and home care industry. Join us in making an impact and shaping the future of home healthcare! About the Opportunity: The CCO-in-Training (CCIT) Program is a 12-week, full time paid executive training program designed to prepare outstanding leaders for an opportunity to lead and manage clinical services and teams in a home health, hospice, or home care setting. CCITs learn how to drive results, cultivate a strong team culture, and develop a deep understanding of the unique business model that powers Pennant's success. Successful CCIT graduates may advance to lead one of our thriving agencies or future agencies, with continued mentorship and operational support from experienced clinical partners. As a CCIT, you will gain hands-on practical experience in high quality clinical care services, agency operations, administrative support, and people leadership skills to equip you to take on a more strategic and elevated Director of Clinical Services position (or equivalent). The CCIT program offers mentorship, cross-functional training, and real responsibility in a dynamic environment. Key Responsibilities: Engage in immersive, on-the-job training across clinical, operational and administrative management functions. Shadow department heads and front-line staff to understand the day-to-day rhythm of agency operations, processes, and clinical controls. Take the lead on real-time projects and contribute to meaningful improvements within your host agency. Prepare for a Director-level role by mastering staffing, team engagement, and community growth initiatives. Study relevant state regulations and best practices in home healthcare operations. Align leadership and interpersonal skills with our CAPLICO core values and mission. Qualifications: Current, unencumbered, active license to practice as a Registered Nurse, Speech-Language Pathologist, Occupational Therapist, or Social Worker in the state where services are rendered; must maintain applicable state licensure requirements at hire, and for the entire duration of employment. Minimum of one (1) year of experience required, preferably in a home health or hospice treatment setting. Current and nationally accredited CPR certification. Enthusiasm, passion for working with people, and an internal drive to improve the lives of individuals in our care. Must understand and adhere to the ethical standards of the respective licensure governing board. Must have a valid driver's license, current automobile insurance, and a safe driving record. Open to relocation based on available opportunities About Us: Cornerstone, an affiliate of The Pennant Group (NASDAQ: PNTG), is committed to delivering compassionate, personalized care to patients and families in the comfort of their own homes. As part of the Pennant family-a growing national network with over 180 affiliated locations across 14 states spanning home health, hospice, and senior living-we operate with the independence and flexibility that allow our local leaders to truly make a difference. Pennant Services provides robust clinical, legal, accounting, IT and HR support, enabling our teams to focus on delivering exceptional service and care. We are guided by the core values that shape Pennant's unique culture: Customer Second Accountability Passion for Learning Love One Another Intelligent Risk Taking Celebrate Ownership We believe in empowering our people, fostering excellence, and creating an environment where personal and professional growth thrives. Our culture makes Pennant a truly unique place to work. The employer for this position is stated in the job posting. The Pennant Group, Inc. is a holding company of independent operating subsidiaries that provide healthcare services through home health and hospice agencies and senior living communities located throughout the US. Each of these businesses is operated by a separate, independent operating subsidiary that has its own management, employees and assets. More information about The Pennant Group, Inc. is available at **************************** #onsite The employer for this position is stated in the job posting. The Pennant Group, Inc. is a holding company of independent operating subsidiaries that provide healthcare services through home health and hospice agencies and senior living communities located throughout the US. Each of these businesses is operated by a separate, independent operating subsidiary that has its own management, employees and assets. More information about The Pennant Group, Inc. is available at ****************************
    $75k-109k yearly est. Auto-Apply 12d ago
  • Director of Clinical Services

    Newvista Behavioral Health 4.3company rating

    Director of clinical education job in Columbus, OH

    Job Address: 10270 Blacklick - Eastern Road NW Pickerington, OH 43147 Role: Director of Clinical Services Job Post Title: Director of Clinical Services Solero Behavioral Transitions We provide a safe and supportive environment for individuals struggling with severe mental illness. Our program offers comprehensive care, including individual and group therapy sessions, case management services and life skills training. A mental health residential facility is a place where people receive intensive, specialized care for mental health and or substance abuse issues in a non-hospital setting. Residents receive 24-hour supervision, treatment, and support from mental health experts. The environment is homelike and supportive, and residents participate in therapeutic activities. Shift: M-F, with a weekend rotation Hours: 8-4:30 Perks at Work Healthcare: Medical Packages with Rx - 3 Choices Flexible Spending Accounts (FSA) Dependent Day Care Spending Accounts Health Spending Accounts (HSA) with a company match Dental Care Program - 2 choices Vision Plan Life Insurance Options Accidental Insurances Paid Time Off + Paid Holidays Employee Assistance Programs 401k with a Company Match Education + Leadership Development Up to $15,000 in Tuition Reimbursements Student Loan Forgiveness Programs Approved HRSA Site Approved STAR-LRP Site The Role Itself License/Education/Certification: Formal education program or training in Quality Improvement/Risk Management/Compliance for inpatient or behavioral health settings. Familiarity with healthcare laws, regulations, accreditation standards, state licensure or certification and Best Practices in healthcare compliance program implementation Knowledge of the principals of The Joint Commission and must be well versed in CMS guidelines Knowledge and understanding of the Regulatory Compliance Ohio Department of Mental Health and Addictions Serves as resource for faculty regarding medical record content and regulatory requirements Ability to adapt to change and work under stressful situation Education: Masters degree in social work with LSW and documented experience in group therapy setting. Counselor Degree Must be 21 yrs or older Top of Form License: LSW, LISW, LPC, LPCC, MFT, LMFT Current unencumbered clinical license per state of practice guidelines. Levels of Care Residential Mental Health Services A service activity which uses clinical and medical interventions, including the administration of physician prescribed medications and clinical monitoring, to help stabilize mental health symptoms to for individuals requiring a more structured and supervised environment. Partial Hospitalization Program Comprehensive Mental Health program with intensive treatment services to help individuals prepare for re-entry into all aspects of their lives including home, work, school and relationships. Program Purpose: We are committed to producing the highest level of clinical outcomes for clients and their families. Solero Behavioral Transitions is a trauma-informed, non-coercive treatment program designed to treat individuals struggling with Mental Health symptoms. The Solero's focused mental health rehabilitation includes; Building Resiliency Optimistic outlook Locus of control Sense of self Ability to bounce back Change management Practical Life Skills Problem-solving Money management Time management Personal change Self-awareness Communication Skills Active listening Nonverbal communication Communication skills Social Radar Negotiation skills These are the core concepts that extend into many areas of a client's life and help develop the foundations for recovery and recovery sustainability.
    $62k-83k yearly est. Auto-Apply 53d ago
  • Director, Clinical Care Services - New Mexico, Remote

    Magellan Health 4.8company rating

    Remote director of clinical education job

    This is a remote position supporting New Mexico. Candidate needs to be licensed in the State where they reside. Maintains accountability for medical management functions to achieve the business and clinical outcomes for the health plan, meeting contract requirements, National Committee of Quality Assurance (NCQA) accreditation standards, and supporting initiatives with providers and members to manage cost of care. Oversees utilization management and criteria-based reviews of care, clinical appeals regarding medical necessity, and the interaction with claims payment policies and processes. Also oversees the health plans 24/7 Nurse Line program and the clinical management of crisis calls. Depending on SBU/product supported, supports goals, contracts, and accreditation requirements of health plan in conducting reviews of clinical interactions and clinical documentation including reviews of case management, utilization management, vendor, and provider records. Collects data following established procedures and analyzes findings for purposes of continuous quality improvement and for internal and external reporting. Interacts with multiple stakeholders internally and externally. Conduct staff audits, process audits and pre-delegation and delegation activities. Reviews audit results with appropriate stakeholder and manages trainings in conjunction with the trainer for individual and/or for unit learning gaps. Directs, coordinates and evaluates efficiency and productivity of utilization management functions. Works closely with SBU and vendors to assure integration, oversight, and efficiency of utilization management and appeals processes and for delegated functions. In collaboration with the national clinical team, assures that all utilization management-related activities meet the standards required for the state contract and NCQA. Leads and organizes the ongoing evaluation of the utilization management program against quality and utilization benchmarks and targets. Identifies opportunities for improvement; organizes and manages cost of care initiatives. Collaborates with local and national leaders including Quality Improvement, Analytics, Finance, Network, and other areas to assure a comprehensive approach to managing quality of care, service, and cost of care. Provides expert input to Finance regarding patterns of utilization and cost and high cost cases. Assures staff selection, training, and evaluation to promote the development of a high quality team and effective transitions of care with the clinical care teams. Works closely with and provides input to national health plan clinical team on program design, policies, procedures, workflows, and correspondence. Collaborates with Network leaders to design and implement successful methods for working with hospitals, home health, and other services providers. Ensures integration and efficiency of Network strategy and vendor relationships with utilization management and claims processes. Works closely with network on the training and evaluation of providers as well in resolving provider related issues. Directs staff who assure quality, inter-rater reliability and standards are met in daily operations. Responsible for resolution and communication of utilization management issues and concerns and corrective action plan activities and reporting. Participates as a member of health plan Quality Insurance Committee and co-chair health plan Utilization Management Committee. Collects, analyzes and prepares record/documents information for projects related to assessing the efficiency, effectiveness and quality of the delivery of managed care services. Prepares monthly performance reports with audit results. Presents findings at provider, customer, UM and CM meetings as needed. Audits and reviews case manager, Health guide, UM staff, vendor, and provider documentation and telephone interactions against health services quality monitoring standards, regulations, accreditation standards and contract requirements. Reviews vendor and/or provider records against clinical and procedural established standards and contract requirements. Leads and conducts ongoing activities which monitor established quality of care standards in the participating provider network, vendors, UM staff, Health Guides, and for case managers. Assists in the planning and implementation of activities to improve delivery of services and quality of care including the development and coordination of in-service education programs for vendors, providers, UM staff, and case managers. Makes recommendations as to required training based upon audit results. Responsible for monitoring and validating internal audit results and/or corrective action plans. Other duties as assigned. The job duties listed above are representative and not intended to be all-inclusive of what may be expected of an employee assigned to this job. A leader may assign additional or other duties which would align with the intent of this job, without revision to the job description. Other Job Requirements Responsibilities 3+ years in utilization management operations. 5+ years in health care quality improvement. Licensure is required for this position, specifically a current license that meets State, Commonwealth or customer-specific requirements. One or more of the following current, active licenses are required: BCBA, LCMFT, LCSW, LMHP, LPC, LPT, LOT or RN. Must have experience overseeing contractual performance standards. Experience with reporting and analyzing managed care utilization data. Strong verbal and written communications skills. General Job Information Title Director, Clinical Care Services - New Mexico, Remote Grade 30 Work Experience - Required Clinical, Management/Leadership, Quality, Utilization Management Work Experience - Preferred Education - Required Bachelor's - Nursing, Bachelor's - Occupational Therapy, Bachelor's - Physical Therapy, Master's - Behavioral Health Education - Preferred License and Certifications - Required BCBA - Board Certified Behavior Analyst - Care MgmtCare Mgmt, LCMFT - Licensed Clinical Marriage and Family Therapist - Care MgmtCare Mgmt, LCSW - Licensed Clinical Social Worker - Care MgmtCare Mgmt, LMFT - Licensed Marital and Family Therapist - Care MgmtCare Mgmt, LMHP - Licensed Mental Health Professional - Care MgmtCare Mgmt, LPC - Licensed Professional Counselor - Care MgmtCare Mgmt, OT - Occupational Therapist, State Licensure - Care MgmtCare Mgmt, PT - Physical Therapist, State Licensure - Care MgmtCare Mgmt, RN - Registered Nurse, State and/or Compact State Licensure - Care MgmtCare Mgmt License and Certifications - Preferred Salary Range Salary Minimum: $105,230 Salary Maximum: $178,890 This information reflects the anticipated base salary range for this position based on current national data. Minimums and maximums may vary based on location. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors permitted by law. This position may be eligible for short-term incentives as well as a comprehensive benefits package. Magellan offers a broad range of health, life, voluntary and other benefits and perks that enhance your physical, mental, emotional and financial wellbeing. Magellan Health, Inc. is proud to be an Equal Opportunity Employer and a Tobacco-free workplace. EOE/M/F/Vet/Disabled. Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their position; and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures.
    $105.2k-178.9k yearly Auto-Apply 10d ago

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