
Unknown Employer · San Mateo, CA
The role: We are seeking an experienced and motivated Clinical Operations Lead to join our drug development team, focusing on early-stage clinical development o...
The role: We are seeking an experienced and motivated Clinical Operations Lead to join our drug development team, focusing on
early-stage clinical development of biologic drugs in oncology and inflammatory diseases. As the Director and Lead of Clinical
Operations, you will oversee the design, execution, and management of clinical trials, ensuring alignment with corporate
objectives and regulatory requirements. You will lead a high-performing clinical operations function, develop strategies to
accelerate development timelines, and establish best practices for trial execution. This is a unique opportunity to contribute at
both strategic and operational levels in a fast-paced, collaborative startup environment.
Who We Are: Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. ---------------------------------------------------------------------------------------------------------------------------------- The Role: Cogent Biosciences is seeking an experienced and highly motivated Associate Director, Clinical Operations to serve as a key operational leader across our clinical development programs. Reporting to the Senior Director, Head of Clinical Operations, this individual will function as both a hands-on study leader and a strategic clinical operations partner, helping drive execution and operational excellence across multiple stages of development. This role is ideal for someone who enjoys balancing operational detail with strategic program oversight—an individual who can independently lead complex global studies while also contributing to broader Clinical Operations strategy, portfolio planning, process improvement, and cross-functional decision-making. The successful candidate will be accountable for the planning, execution, oversight, and delivery of clinical trials across early-stage development programs, with opportunities to support later-stage development as programs advance. This individual will serve as a trusted partner to the Head of Clinical Operations and will be expected to identify risks proactively, influence key stakeholders, and help scale operational excellence within a growing clinical organization. We are seeking someone who brings strong operational expertise, a sense of ownership, intellectual curiosity, and a willingness to work at both the strategic and tactical levels. The ideal candidate is equally comfortable reviewing site-level enrollment challenges, leading vendor governance discussions, influencing development strategy teams, and driving complex cross-functional initiatives. ---------------------------------------------------------------------------------------------------------------------------------- Responsibilities: * * Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of study objectives on timeline, budget, and quality expectations. Provide strategic oversight of CROs and vendors, ensuring accountability, quality, and operational execution. * Develop and review study performance metrics and drive corrective and preventive actions when needed. Evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in the review clinical data. * Develop strong partnerships with external stakeholders while maintaining sponsor ownership of study execution. Serve as Clinical Operations representative on Strategy Teams, and coordinate and lead study team meetings and update the cross-functional Team on timelines and milestones for the study. * Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, designing CRFs, and ensure proper team and external training. * Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing. * Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors * Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, motivational, and sponsor oversight visits, as needed * Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house. * Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs. * Limited travel possible to clinical sites for investigator and site engagement, with potential to travel (~25%). ---------------------------------------------------------------------------------------------------------------------------------- Qualifications: * * BS/BA Degree or equivalent in science or a health-related field is preferred * Minimum 6-7+ years of relevant industry clinical development experience * Experience with complex therapeutic platforms * Multi-phase clinical trials * Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring * Familiarity with clinical data review and data management processes * Excellent knowledge of GCP, ICH, and FDA regulations * Experience with SOP review and development ---------------------------------------------------------------------------------------------------------------------------------- Salary Range: $185,000- $215,000USD Target Bonus: 20% Exact compensation will vary based on skills, experience, and location. ---------------------------------------------------------------------------------------------------------------------------------- Our Locations Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building. Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline. ---------------------------------------------------------------------------------------------------------------------------------- Our Offer To You At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 401(k) match with immediate vesting, generous paid time off, 12 weeks of fully paid parental leave, paid family and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond. We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
Weekly outpatient therapy isn't always enough, and a trip to the ER isn't the only answer. Patients and their families rely on Compass Health Center when in crisis – every day, we help people overcome depression, anxiety, suicidality, obsessions/compulsions, trauma, chronic pain, and other obstacles in order for our patients to live freely. About This Role We are seeking an experienced Senior Director to join us. In conjunction with the Executive Director, the Senior Director is responsible for the overall success of the site. They will provide clinical, quality, and operational oversight and leadership to all partial hospital and intensive outpatient programs, services, and staff at the facility. The Senior Director will be responsible for ensuring the site meets or exceeds the organization's standards for clinical quality, immediate access to care, a healthy culture embodying our core values, and budgetary expectations. The Senior Director will work collaboratively with other department leaders and/or their designees including, but not limited to, admissions, center of excellence, psychiatry, finance, strategy, nursing, clinical leadership, and human resources to achieve site and organizational goals. The Senior Director will report to the Executive Director. What You’ll Do: * Operational Oversight: Direct daily operations, including staff management, scheduling, budgeting, and resource allocation, ensuring the smooth functioning of the site. * Continuous Improvement: Create a culture of continuous improvement at the site and an environment of innovation. Manage for daily improvement through huddles and help foster a staff of problem solvers with the support of the Sr. Director of Operational Excellence. * Regulatory Compliance: Ensure compliance with state license requirements, HIPAA guidelines, Joint Commission standards, and other relevant standards to maintain confidentiality and safety for both patients and staff. * Quality Assurance: With support and assistance from the site’s clinic director and psychiatry leader(s), ensure partial hospital and intensive outpatient programs provide high standards of care evidenced, track patient outcomes and implement quality improvement initiatives * Financial Management: In conjunction with the Executive Director, manage the site’s budget, meet/exceed census expectations, manage/reduce expenses, identify opportunities to enhance revenue, and optimize resources. * Patient Experience: Ensure immediate access to partial hospital or intensive outpatient services to all appropriate patients. Foster a supportive environment for patients seeking treatment. * Outreach: Cultivate partnerships with community organizations, mental health professionals, hospitals/health care systems, and other key stakeholders in collaboration with Marketing. * Team Leadership: Interview, train, and supervise site staff. Conduct performance evaluations and provide ongoing feedback to support staff and manager/director development. * Collaboration: Establish positive relationships and collaborate with centralized departments (such as Clinical Operations, Center of Excellence, Intake, Human Resources, etc) ensuring service delivery meets internal standards, and Compass guidelines are implemented effectively. Partner effectively with onsite psychiatry and psychiatry leadership to ensure alignment and support of the aforementioned duties/responsibilities. * Key Initiatives: Spearhead the implementation and execution of organizational/system wide initiatives at the site (e.g. treatment adherence, optimal dose, etc). Participate in weekly Senior Leadership meeting. Who You Are: * Master’s degree in Healthcare Administration, Business Administration, or a related field * Preferred: Licensed Doctorate Level Psychologist, Masters Level Clinician with clinical license, or a postgraduate degree in a healthcare field * 5+ years behavioral health/substance use experience * 3+ years proven management/leadership experience in behavioral health/substance use settings * Preferred: partial hospital and/or intensive outpatient setting * Preferred: previous admissions experience * Preferred: new program development experience * Excellent leadership, organizational, and communication skills * Continuous improvement/problem solving/lean transformation * Team building, change management, staff development * Knowledge of group dynamics utilizing Cognitive Behavioral Therapy (CBT) and Dialectical Behavior Therapy (DBT), as well as other empirically supported treatments. * Strong knowledge of healthcare regulations, compliance, and accreditation standards * Knowledge of commercial payor environment and utilization review * Preferred: established relationships with commercial payors (ie BCBS, UBH/Optum, etc) * Ability to juggle multiple demands simultaneously in a fast paced and changing environment We know job descriptions can be intimidating, so if this sounds like an opportunity for you, please don't hesitate to apply! Who We Are Compass Health Center is a recognized leader in crisis-level mental health, bringing passion, connection, and patient-centered care to the Partial Hospitalization and Intensive Outpatient space (PHP/IOP). Based in Chicagoland, we serve hundreds of patients every day, ranging from ages 5 through adulthood, in our onsite facilities or through our flourishing virtual programming. Compass fills a critical gap between outpatient and inpatient care through an intermediate level of Behavioral Healthcare. A few more things we want you to know: our values are super important to us, and hopefully will be to you, too. Cultural humility, teamwork, continuous improvement, connection, patient centered care, passion, innovation, and agility should be your power sources. Joining Compass is an opportunity to feel fulfilled through a joint mission towards healing our communities. Benefits & Perks We know that you will be dedicated to your purpose here. We look at that investment as a two-way street. We are proud to offer plenty of space for growth, and opportunities to pursue continuous development within our organization. For eligible positions, our other benefits include: comprehensive medical/dental/vision plans, 401k program with company matching, generous PTO (including competitive parental leave after 1 year of employment), and continuous training through CEU seminars and volunteering opportunities. What’s Next? Compass is committed to cultivating diverse and dynamic teams who exude passion for their craft, so whether or not you check all the boxes, we encourage you to apply – we’d be grateful to hear from you!
Description Director of Home -Based Services The Center for Elders’ Independence (CEI) is a PACE (Program of All-Inclusive Care for the Elderly) organization that uses an interdisciplinary team (IDT) approach to deliver high-quality, integrated, and participant-centered care. CEI is committed to promoting autonomy, quality of life, and the ability for older adults to remain safely in their communities. The Position : Reporting to the Senior Director of Support Programs, the Director of Home-Based Services provides strategic, clinical, and operational leadership across home care (non-skilled services) , home health (skilled nursing ) , and hospice . This role is responsible for ensuring high-quality, efficient, and compliant delivery of in-home services within the PACE model. The Director leads interdisciplinary collaboration, optimizes utilization and outcomes, strengthens vendor and internal service delivery models, and drives continuous improvement in participant experience, clinical quality, and cost effectiveness. The annual pay range for the Director of Home Based Services position at Center for Elders’ Independence is $ 128,530 to $ 205,658 per Year . Placement within the range is determined based on job-related factors such as relevant experience, skills, abilities, internal equity, and market data, consistent with CEI’s annual compensation review and established compensation practices. Duties and Responsibilities Provides overall leadership and direction for Home Care , Home Health Nursing , and Hospice f unctions. Serves as a key leader within the IDT model, ensuring seamless integration of in-home services with center-based and external care. Leads cross-functional initiatives that improve operational efficiency, scalability, and quality of care. Ensures all services align with individualized participant care plans developed by the IDT. Partners with IDT members, participants, and caregivers to resolve complex care issues and optimize care plans. Ensures compliance with all applicable regulatory requirements (CMS, DHCS, California Board of Registered Nursing, and PACE standards). Leads quality improvement initiatives focused on clinical outcomes, participant satisfaction, and service reliability and timeliness. Monitors and reports key performance indicators, including home health utilization, service delivery timeliness, and participant outcomes. Oversees audit readiness, documentation standards, and corrective action planning. Manages utilization of home care , home health , and hospice services to ensure appropriate, cost-effective care delivery. Oversees departmental budgets, staffing models, and resource allocation. Drives strategies to reduce unnecessary utilization while maintaining quality outcomes. Monitors and manages contracted vendor performance, ensuring adherence to service, quality, and financial expectations. Directly oversees supervisors, coordinators, and clinical staff across home care and home healt h, as well as oversee s the hospice program. Builds a high-performing team through hiring, onboarding, coaching, and performance management. Ensures staff competency, training, and adherence to clinical and operational standards. Aligns home-based services with organizational goals and participant care needs. Oversees resolution of complaints, grievances, and service concerns related to home care , home health , and hospice . Ensures timely follow-up, root cause analysis, and implementation of sustainable improvements. Develops and maintains policies, procedures, and protocols for all service areas. Participates in organizational committees, QI programs, and leadership meetings. Maintains confidentiality and compliance with all CEI policies and regulatory requirements. Performs other duties as assigned. Qualifications and Licensure Education & Experience Bachelor of Science in Nursing (BSN) required . Master’s degree in N ursing , Public Health, Healthcare Administration, or related field preferred . Minimum of five (5) years of nursing experience across home health, acute, or community-based care . Minimum of five (5) years of progressive leadership experience in clinical operations, home car e, or home health . Experience working with frail or elderly populations required; PACE experience strongly preferred . Licensure & Certification Active Registered Nurse (RN) license in California, in good standing . Current CPR/BLS certification required . Valid California driver’s license, insurance, and reliable transportation . Skills & Competencies Strong clinical, operational, and financial management expertise Deep understanding of care coordination, transitions of care, and population health management Demonstrated ability to lead interdisciplinary teams in complex healthcare environments Experience with regulatory compliance and quality improvement programs Proficiency in EMR/EHR systems, data analytics, and Microsoft Office tools Excellent communication, leadership, and problem-solving skills Ability to manage multiple priorities in a fast-paced environment Physical, Functional, and Environmental Requirements The physical and mental demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. Physical Requirements Ability to sit for extended periods—up to 6–8 hours per day—at a computer workstation in a typical office environment. Occasional walking, standing, and light physical activity while attending meetings or conducting site visits at CEI centers or participant homes. Occasional lifting, carrying, or handling of materials or equipment weighing up to 20–30 pounds (e.g., laptops, binders, or small office equipment). Manual dexterity and fine motor skills required for computer use, phone operation, and other standard office tasks. Visual and auditory acuity sufficient to use a computer, participate in virtual and in-person meetings, and communicate clearly. Ability to travel between CEI locations and community sites as needed. Functional Requirements Ability to prioritize and manage multiple complex tasks and projects simultaneously. Sound clinical judgment and decision-making skills in high-pressure situations. Strong attention to detail and accuracy in assessment, documentation, and follow-up. Ability to problem-solve and implement effective solutions using critical thinking and evidence-based practices. Capacity to supervise and evaluate staff, interpret policy and regulation, and participate in strategic planning. Environmental Requirements Work is performed in various settings including CEI offices, centers, and community environments. May be exposed to noise, odors, varying temperatures, and potentially hazardous conditions or equipment when visiting participant residences. Occasional exposure to infectious materials or environments requiring adherence to universal precautions and PPE protocols. Must be able to adapt to changing priorities and needs of a dynamic healthcare environment. The above job description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required. CEI reserves the right to change job descriptions, site assignments, and or work hours as required by the needs of the program. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management. Center for Elders’ Independence is a PACE (Program of All- Inclusive Care for the Elderly) organization that uses an interdisciplinary team approach to care planning and care implementation for the purpose of providing high quality, affordable, integrated health care services to the elderly, including an Adult Day Health Center, and promoting autonomy, quality of life and the ability of individuals to live in their communities. Unlike other healthcare plans, CEI is not a "fee-for-service" plan. It is a “capitation” healthcare plan. CEI is paid a set amount for each person enrolled in our program, whether or not that individual seeks care. We are a growing company that offers stability and continues to thrive.