Associate Director jobs at Regeneron - 3800 jobs

Responsibilities: Archcare is seeking a dynamic forward-thinking Executive Director with a proven track record of a Licensed Home Care Services Agency program growth. The Executive Director is a key member of the homecare team and leads the overall vision of the agency and oversees the daily clinical and financial operations of the agency. Reporting to the Senior Vice President of Home & Community Based Services, this position directs the delivery of quality professional and paraprofessional services and strategizes around the big picture goals. The areas of responsibility for this role include oversight of scheduling/staffing, recruiting of staff including Home Health Aide, Personal Care Aides, Registered Nurses and Licensed Practical Nurses, client management, fiscal integrity and regulatory compliance. This individual will lead the development of strategies to expand programs and services and promote organizational growth. Achievement of annual assigned gross profit goals through retention of assigned clients and achievement of financial goals. Plan, organize, direct, and evaluate operations to ensure the provision of adequate and appropriate care and services. Develop distinctive strategies to achieve competitive advantage; translate broad growth, and other relevant strategies into specific objectives and action plans; align the organization to support strategic priorities. Ensure successful system integration by maximizing internal referrals from other Archcare programs. Direct and monitor the progress of the Archcare Care Transitions Initiative to reduce avoidable hospitalizations. Plan, prepare, and utilize financial records (including budgets, forecasts, payroll data, etc.) and key metrics to analyze and make decisions to meet specific strategic and financial goals. Take timely and appropriate corrective actions when necessary to ensure financial expectations are met. Assist with and coordinate and/or lead marketing activities and business development to increase revenues and reduce costs. Design, implement and maintain processes to maximize quality of operations. Demonstrate strong execution skills by outlining goals and expectations, assigning responsibilities and clearly defining roles; delegate to and empower others, remove obstacles, allow for and contribute needed resources, coordinate work efforts when necessary, and monitor progress. All other duties as assigned. Please Note: This is not a remote position. Qualifications: Current NYS Registered Nurse license Proficient in HHAeXchange 10+ years of experience in a leadership role Strong knowledge of New York State home health care regulations, reimbursement, and quality measures, including familiarity with funding sources. Experience in multi-department team management. Financial literacy and operations expertise. Excellent negotiation and project management abilities. Ability to develop and foster teamwork in a collaborative and collegial environment. Willingness to roll up one's sleeves when necessary. Excellent oral and written communication skills. Excellent organizational and computer skills. Education: BA/BS from an accredited university

Nutrition Services Director Career Opportunity Appreciated for your Nutrition Services skills Are you in search of a career close to home and heart, where your nutrition expertise can make a significant impact? As the Nutrition Services Director at Encompass Health, you will lead the coordination and direction of our Nutrition Services Department. Your responsibilities will include setting and implementing policies and procedures that guide cafeteria management, food preparation, budgeting, purchasing, staff development and safety practices. If you are passionate about having a career close to home and heart, then consider joining us to help patients heal. A Glimpse into Our World At Encompass Health, you'll experience the difference the moment you become a part of our team. Working with us means aligning with a rapidly growing national inpatient rehabilitation leader. Our achievements include being named one of the "World's Most Admired Companies" and receiving the Fortune 100 Best Companies to Work For Award, among other accolades, which is nothing short of amazing. Starting Perks and Benefits At Encompass Health, we are committed to creating a supportive, inclusive, and caring environment where you can thrive. From day one, you will have access to: Affordable medical, dental, and vision plans for both full-time and part-time employees and their families. Generous paid time off that accrues over time. Opportunities for tuition reimbursement and continuous education. Company-matching 401(k) and employee stock purchase plans. Flexible spending and health savings accounts. A vibrant community of individuals passionate about the work they do! Become the Nutrition Services Director you always wanted to be Manage Departmental budget as it relates to position. Perform and document all purchasing, receiving, and inventory control of food and supplies. Maintain proper sanitation, temperature, and food handling techniques to comply with regulations. Determine quality, quantity and portion size of food required and ensure proper handling of food. Ensure adequate staffing and management of the department's employees. Ensure production for both patient meals and cafeteria line are properly coordinated. Develop cafeteria menu as needed. Purchase food, assist with and assign duties for special needs or special occasions. Qualifications Registered Dietitian (RD/RDN) with the Commission of Dietetic Registration (CDR) or Certified Dietary Manager (CDM) with the Certifying Board for Dietary Managers (CBDM) or an executive chef required. Three to five years of healthcare clinical nutrition, or executive chef experience required. Ten plus years healthcare food service experience, or five plus years of healthcare management experience required. Graduate of a Bachelor's degree program in Dietetics, Culinary Arts or related field preferred. Must have thorough knowledge of nutrition and dietetics, administration, and operation of hospital food services, and knowledge of all H.A.C.C.P. guidelines. We're eagerly looking forward to meeting you, and we genuinely mean that. Join us on this remarkable journey! The Encompass Health Way We proudly set the standard in care by leading with empathy, doing what's right, focusing on the positive, and standing stronger together. Encompass Health is a trusted leader in post-acute care with over 150 nationwide locations and a team of 36,000 exceptional individuals and growing! At Encompass Health, we celebrate and welcome diversity in our inclusive culture. We provide equal employment opportunities regardless of race, ethnicity, gender, sexual orientation, gender identity or expression, religion, national origin, color, creed, age, mental or physical disability, or any other protected classification.

Host Healthcare is seeking a travel nurse RN Psychiatric for a travel nursing job in Pasco, Washington. Job Description & Requirements • Specialty: Psychiatric • Discipline: RN • 40 hours per week • Shift: 8 hours, days • Employment Type: Travel Host Healthcare Job ID #a1fVX000002Ywd8YAC. Pay package is based on 8 hour shifts and 40 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: RN - Interim DON About Host Healthcare At Host Healthcare, we provide a truly comfortable experience as you explore your travel nursing, therapy, or allied career. We make your travel healthcare journey easy by taking care of all the details, so you don't have to. We are on a mission to help others live better and we do this by helping the healers of the world be as comfortable as possible. With access to tens of thousands of travel nursing, therapy, and allied jobs in all 50 states, our responsive and friendly recruiters find your dream position based on what's important to you. During your assignment, get access to premium benefits, including Day 1 medical that continues up to 30 days between assignments, 401K matching, travel reimbursements, dedicated housing support, and more. We also offer 24/7 support from our team and access to our on-staff clinicians so you can feel comfortable and confident throughout your entire assignment. Travel comfortably with Host Healthcare. Benefits • Referral bonus • School loan reimbursement • Vision benefits • Wellness and fitness programs • Company provided housing options • License and certification reimbursement • Life insurance • Medical benefits • Mileage reimbursement • Pet insurance • Discount program • Employee assistance programs • Guaranteed Hours • Health savings account • Holiday Pay • 401k retirement plan • Continuing Education • Dental benefits

*Employment Type:* Full time *Shift:* Day Shift *Description:* The Executive Director of Clinical Operations, Maternal Child and Inpatient Services at Saint Joseph's Health System partners with the Medical Director of the service line to strategically plan and lead in the development and continuous quality improvement of the service line and/or achieving key outcomes. They provide oversight of the overall quality, service, operations and financial performance of the service line and assume integration of the service line with the organization. Position responsibilities: * Uses solid advanced leadership skills to assure that quality patient care and services are delivered through the Service Line, resulting in positive clinical performance. * Assures that key clinical indicators are identified; appropriate targets are set: clinical results meet organizational targets. * Uses national, regional, and internal result databases/research to assist in identifying the service line's opportunities, as well as methods, for improving clinical results. * Assures that effective written and oral communication methods and processes are in place involving the Director, Medical Director, other leaders, and direct care staff to discuss patient care issues. * Assures that care and services are rendered and documented so as to meet all organizational and service line objectives. * Is visible on clinical area on a regular basis to assess and promote culture of service excellence. * Assures the identification, development, and retention of key employees throughout the service area. * Uses innovation in achieving and maintaining organizational targets for patient perception of care, physician perception of care, and associate perception of SJHS as a workplace. * Integrates services within the organization contributing to a seamless delivery of care/products. * Assures that patient care guidelines used within the service line include the continuum of care. * Serves as a resource across departmental lines for assistance in resolution and /or clarification of issues involving the service line. * Assures that support departments, such as finance, outcomes management, marketing, patient financial services, etc. are integrated into the planning, execution and evaluation of all Service Line activities as appropriate. * Assures that direct care staff, all relevant clinical disciplines, including physicians, are included in PI activities and strategic planning. * Actively seeks opportunities to contribute expertise in a variety of activities including community involvement (ie committees, projects) to assist the organization to achieve its strategic initiatives. * Assures that service line financial targets are met. * Participates in annual forecasting and determining Service Line financial targets. * Approves annual budgets prepared by managers/directors; assists when necessary. * Plans and advocates for capital needs during the annual budget process. * Reviews dashboards of key targets, identifies variances and trends; works with Medical Director and managers/directors as appropriate to resolve variances. * Is knowledgeable regarding reimbursements by payor class for services rendered; partners with Patient Financial Services to assure that appropriate reimbursements are being received. * Uses and encourages innovation in resource utilization; assures fiscally efficient operations. * Prepares concise review of service line. * Uses innovation and expert knowledge of industry trends and market opportunities to strategically plan for service line enhancements/expansion or alterations in focus. * Annually updates the service line business plan and strategic initiatives assuring the plan is aligned with the organization. * Regularly assesses market and technological opportunities for application at SJHS. Identifies those opportunities that would contribute to strategic initiatives; develops and implements plans for maximizing identified opportunities for growth. * Develops and regularly reviews succession plans for expected and unexpected vacancies in key service line positions. * Functions as the expert in service line products and services; enhances expertise with readings, networking, site visits, and seminars. * Duties & responsibilities include accuracy of documenting services and supplies provided to patients, including those that may produce patient charges. If designated as a “Revenue Lead”, additional responsibilities will include revenue reconciliation and charge-error correction as specified by departmental process and hospital policy. * Manages subordinates in respective department(s). Is responsible for the overall direction, coordination, and evaluation of these department(s). * Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. * Actively demonstrates the organization's mission and core values and conducts oneself at all times in a manner consistent with these values. * Knows and adheres to all laws and regulations pertaining to patient health, safety and medical information. What's required: * A minimum of 5-10 years of experience in service line management in an organization of comparable size, range and scope of product lines and services. * Master's degree in Nursing, Healthcare Administration, or related field. * A current RN License in the State of Indiana. * Must have a general knowledge of diagnostic treatment and aftercare, methodologies and programs. * National Certification preferred. * Assigned hours within your shift, starting time, or days of work are subject to change based on departmental and/or organizational needs. *Why Saint Joseph Health System?* At Saint Joseph Health System, our values give us strength. That character guides every decision we make - even when those decisions are complicated, costly or hard. We honor our mission to care for every man, woman and child who needs us by investing in technology, people and capabilities that allow us to set the standard for quality care. *What we offer:* * Tuition reimbursement for all full and part-time colleagues effective first day of employment * Benefits day one (Including: Medical, Dental, Vision, PTO, Life, STD/LTD, etc.) * Retirement savings account with employer match * Generous paid time off program + 7 paid holidays * Colleague well-being resources * Employee referral incentive program *Our Commitment * Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. This individual will be responsible for providing strategic regulatory direction and managing CMC related activities in close partnership with cross‑functional development teams, ensuring compliance with global regulatory standards and alignment with internal program goals. This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work. Key Responsibilities Lead regulatory CMC strategy and execution for assigned development programs. Provide regulatory and scientific expertise to shape CMC strategies for development programs. Collaborate cross-functionally with technical and regulatory teams to support product development and lifecycle management. Oversee preparation, review and submission of high-quality CMC sections for investigational and registration submission (INDs, IMPDs, NDAs, MAAs, and amendments) in alignment with Health Authority requirements. Work within the department and cross-functionally to establish regulatory CMC strategies for product development and commercialization. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Lead teams in preparation of responses to Health authority related queries through cross functional collaboration. Develop strategies and lead teams in the preparation of key CMC related Health Authority meetings, including development of meeting information packages. Foster relationships and proactively communicate with key stakeholders. Develop and implement best practices based on current/emerging industry trends and relevant Health Authority guidance and regulations. Skills and Abilities In-depth understanding of relevant Health Authority regulations, guidelines and regulatory trends (FDA, EMA, TGA, Health Canada, ICH, WHO). In-depth knowledge of drug development process within pharmaceutical and/or biopharmaceutical industries. Monitor global developments in CMC regulations, guidelines, and industry trends, to evaluate their potential impact on Alkermes' products. Good judgement in identifying risks and elevating issues to Regulatory Management. Advanced writing skills with ability to deliver high quality regulatory documents. Ability to influence decisions and help develop solutions. Excellent oral communication skills. Commitment to continuous improvement and best practices. Ability to manage multiple priorities in a fast‑paced environment. Basic Qualifications Bachelor of Science in a scientific discipline; post graduate #J-18808-Ljbffr

A leading biopharmaceutical company is seeking an experienced Associate Director for Regulatory Affairs CMC to provide strategic regulatory direction and manage various CMC activities related to a late-stage development program. The role requires expertise in regulatory compliance and the ability to collaborate with cross-functional teams. This position supports a hybrid workplace model located in Waltham, MA. #J-18808-Ljbffr

Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now - JobsAI. The Associate Director, Field Operations & Reimbursement supports operational excellence for Vertex's US Market Access customer engagement teams. They support the USMA Field reimbursement team, collaborating with internal partners to support field activities and the field account reimbursement lead (ARL) program for current and future CGT products. They report to the Vice President, US Market Access Field teams, and work closely with the Head of Field Reimbursement to support day-to-day ARL priorities. Location: Hybrid in-office at least 3 days per week. Responsibilities Lead for field internal meeting support (Plan of Action meetings (POA), launch meetings, manager meetings) to support ARL field team including development of meeting agendas and align with cross-functional colleagues to ensure focus on key priorities and goals across all therapeutic areas. This individual will work closely with market access strategy, brand teams, payer, trade and HEOR field teams, field training, Heme and Diabetes commercial business units, and marketing operations for these activities. Serves as project manager for all above activities and aligns internal stakeholders on milestones, dates, deliverables well in advance of deadlines. Coordinate and update ways of working across multiple internal teams including access and trade escalations Market access lead for CGT field reimbursement and access conferences, memberships, and sponsorships including coordination of customer meetings, strategic planning, and sponsorship activities as well as budget support. Coordinate with field training to ensure effective roll-out of field training resources. Collects, summarizes, and provides market access field training needs related to the current issues and trends to the extended team and leadership. Support goal setting process, strategic planning, and activities including business planning for accounts. Spearhead the MBO process and coordinate field level contests for the ARL team Collaborate with HQ cross-functional and ARL teams to identify market opportunities and develop and evolve comprehensive strategies and tactics across USMA customer segments. Contributes to the development of market access field scorecards to track customer-specific critical success factors, strategic imperatives, key tactical programs, performance metrics and KPIs. Leverages internal and external data including feedback via CRM dashboards and insights to enhance understanding for reporting, dashboards, and consolidated insights to inform field and HQ stakeholders. Coordinate field alignment structure and future re-alignments Supports Head of field reimbursement in assisting slide creation and editing for leadership and cross-functional meetings. Qualifications Bachelor's Degree 5 years' relevant experience in life sciences organization or healthcare industry, including 2 years' experience in market access/managed care or patient services, or equivalent education and experience. Field reimbursement and/or hospital experience preferred. Strong project management experience Understanding of the pharmaceutical regulatory environment Outstanding oral and written communication skills PowerPoint and Excel knowledge and experience Excellent interpersonal, communication, organizational and facilitation skills Able to perform in a fast-paced environment, manage multiple priorities simultaneously, and communicate complex information clearly. Independent worker with demonstrated troubleshooting and critical thinking skills. #J-18808-Ljbffr

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: This position is responsible for developing and implementing CMC regulatory strategies. The role involves coordinating and preparing CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of RevMed's pipeline compounds/products. Responsibilities: Develop, lead, and implement global CMC regulatory strategies to support the clinical development through registration and post-marketing activities. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs. Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are appropriately met. Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives. Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle. Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed's products. Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders. Required Skills, Experience, and Education: BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field. 10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs. Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM). Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues. Demonstrated experience in effective collaboration with internal and external stakeholders. Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment. Effective written and verbal communication skills and excellent interpersonal skills. Preferred Skills: Advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable. Working experience and content knowledge in CMC development of NCEs / small molecules or equivalent. Self-driven, proactive, and able to operate independently while fostering collaboration across departments. Ability and desire to coach and mentor junior regulatory CMC RA staff. #LI-Hybrid #LI-CT1 #J-18808-Ljbffr

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity The Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes. Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks. Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence. Help drive operational decision making and planning within the department, overseeing workflow, assignments, and staff development with minimal direction. Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives. Able to proactively identify risks and devise mitigation strategies. Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams. Perform regulatory research to inform business strategy. Assess and communicate risks. Assure that there are no significant interruptions to the business due to regulatory compliance issues. Collaborates across the organization at all levels, across functional groups, and with executive management. Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. Required Skills, Experience and Education Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs. Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities. Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management. Excellent communicator. Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines. Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred. Preferred Skills Direct experience with oncology drug development highly preferred. Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred. Direct experience with FDA expedited programs highly preferred. #J-18808-Ljbffr

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Playing a critical role within the Pharmaceutical Development and Manufacturing (PDM) organization, the position will be responsible for planning and delivering clinical supplies to support RevMed's clinical development programs. Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan. Plan and deliver on-time, compliant clinical supply per the clinical development plan. Collaborate with cross-functional teams (i.e. Clinical Operations, QA, PDM, and Regulatory) to ensure continued advancement of the clinical programs. Lead and manage clinical supply and logistics activities, including but not limited to: demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management. Author, review, and/or approve related clinical and technical documents, including but not limited to: clinical label text, clinical/master batch record, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA. Support vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution. Conduct necessary training and develop/improve required SOPs. Required Skills, Experience and Education: B.S. or M.S. in scientific fields with 8+ years of experience in clinical supply chain and logistics. Working knowledge of import and export laws and processes. Working knowledge of pharmaceutical drug product development and manufacturing. Solid organizational and time management skills. Effective, open, and transparent communication skills (verbal and written). Capable of working on multiple projects/tasks and able to meet timelines. Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment. Preferred Skills: Strong experience managing clinical supply activities for global phase 3, randomized, oncology clinical trials. Experience managing a team, directly or in a matrix setting. #J-18808-Ljbffr

A biopharmaceutical company located in Redwood City is seeking a dynamic Vice President of Commercial Operations to lead all operational aspects supporting the launch of its first rare disease therapy. The role involves managing sales operations, analytics, and market access operations. Candidates should have extensive experience in commercial operations within the biopharmaceutical sector, especially in rare diseases. This position offers a competitive salary range of $330,000 to $360,000 along with comprehensive benefits. #J-18808-Ljbffr

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI) We are seeking a dynamic and experienced Vice President of Commercial Operations to establish and lead all operational aspects of our commercial strategy in support of the launch of our first rare disease therapy. This includes managing commercial operations functions ensuring the infrastructure, processes, and strategies necessary for successful product launch. This individual will be a strategic and hands‑on leader responsible for building and managing critical commercial infrastructure, including sales operations, analytics, forecasting, market access operations, and commercial systems. This role oversees sales operations, forecasting and analytics, incentive compensation, market research, data management, CRM systems, field effectiveness, and commercial training. The ideal candidate has experience in rare disease or specialty pharmaceutical markets and thrives in an entrepreneurial, fast‑paced environment. The ideal candidate has experience in rare disease or specialty pharmaceutical markets and thrives in an entrepreneurial, fast‑paced environment. Key Responsibilities Serve as a key member of the Commercial Leadership Team, developing and executing commercial strategy and operations plans. Develop and execute the commercial operations infrastructure to support a successful rare disease product launch. Lead commercial planning processes, including sales forecasting, demand planning, incentive compensation design, and territory alignment. Build and oversee a high‑functioning sales operations team and associated systems (CRM, data warehousing, reporting dashboards). Establish data governance processes and manage third‑party vendors providing data (claims, specialty pharmacy, distribution). Partner cross‑functionally with Market Access, Marketing, Medical Affairs, Finance, and IT to ensure alignment of commercial operations with overall corporate goals. Design and manage KPIs and reporting frameworks to track performance and inform commercial decision‑making. Lead field force enablement efforts, including CRM configuration, targeting, call planning, and field reporting. Support the development of compliant policies and processes for commercial activities in collaboration with Legal and Compliance teams. Manage operational budgets, contracts, and vendor relationships for commercial functions. Qualifications Bachelor's degree required; MBA or advanced degree preferred. 12+ years of progressive experience in commercial operations within the biopharmaceutical industry, including at least 5 years in a leadership role. Direct experience supporting launch planning and execution for rare disease or specialty products. Deep understanding of commercial data sources (e.g., specialty pharmacy, HUB services, patient services, claims data). Demonstrated success in building commercial infrastructure in a high‑growth or startup environment. Strong project management skills, attention to detail, and ability to lead cross‑functional initiatives. Excellent communication and leadership skills with a collaborative approach. Familiarity with compliance regulations in the rare disease space. Preferred Attributes Experience in both pre‑commercial and commercial‑stage biotech organizations. Entrepreneurial mindset and comfort operating in a fast‑paced, evolving environment. Ability to work in a lean organization with a hands‑on, roll‑up‑your‑sleeves style. Passion for serving patients with serious or underserved diseases. Benefits Health Insurance (Medical / Dental / Vision) Disability, Life & Long‑Term Care Insurance Holiday Pay Tracking Free Vacation Program 401(k) Plan Match Educational Assistance Benefit Fitness Center Reimbursement Rezolute (RZLT) currently anticipates the base salary for the Vice President of Commercial Operations role could range from $330,000 to $360,000 and will depend, in part, on the successful candidate's geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Qualifying employees are eligible to participate in benefit programs such as: We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. #J-18808-Ljbffr

Associate Director, Toxicology page is loaded## Associate Director, Toxicologylocations: South San Francisco, Californiatime type: Full timeposted on: Posted 30+ Days Agojob requisition id: R67Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.**Job purpose**As the Associate Director of Toxicology, you will play a critical role in advancing our innovative drug discovery and development programs by providing expert guidance and hands-on toxicology and safety pharmacology support. In this highly impactful position, you will have the opportunity to apply your deep toxicology knowledge and industry experience to design and manage non-clinical safety studies, provide strategic input to project teams, and ensure the highest standards of scientific and ethical conduct. You will be an integral member of cross-functional teams, collaborating closely with colleagues in Discovery Biology, Pharmacology, Medicinal Chemistry, DMPK, CMC and Clinical to drive our programs forward.Your strong analytical skills, decisiveness, and goal-oriented approach will be key to meeting timelines while upholding scientific excellence. In this role, you will also oversee contracts, budgets and CRO relationships for outsourced toxicology studies. Your regulatory expertise will be leveraged to provide high-quality, submission-ready documentation for regulatory filings.**Responsibilities*** Apply your extensive toxicology expertise to design, manage, analyze, interpret and report on safety pharmacology and toxicology studies, including general toxicology, genetic toxicology, developmental & reproductive toxicology (DART), as well as toxicokinetics.* Draft, review and approve toxicology study protocols, reports, associated nonclinical summaries, regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication* Provide strategic toxicological assessments and preclinical guidance to project teams and senior management to inform key program decisions and clinical/regulatory strategies* Oversee contracts, budgets and CRO relationships for outsourced toxicology/safety pharmacology studies to ensure the highest standards of scientific and ethical conduct* Maintain up-to-date toxicology plans for all IND and NDA enabling projects/programs including listings of studies, timelines, status, and costs; update and refine as necessary.* Assess the risk of drug candidates on reproductive health, particularly in relation to exposure levels and durations* Leverage your regulatory expertise to provide high-quality, submission-ready documentation for interactions with health authorities**Qualifications*** PhD in Toxicology or related health discipline with 7+ years of industry-related experience in regulatory toxicology in the conduct of regulatory submissions; DABT certification a plus* Extensive hands-on experience in all facets of toxicology study conduct with a proven track record of conducting preclinical drug safety assessments; an emphasis on developmental and reproductive toxicology is a plus* Experience in outsourcing and external oversight of nonclinical toxicology studies conducted by qualified CROs* Deep knowledge of global regulatory requirements for non-clinical safety packages across all phases of development; Experience in working with U.S. and European regulatory authorities* Excellent communication skills to present complex scientific information to diverse audiences and author regulatory documents and scientific publications* Ability to make risk assessments and represent toxicology perspectives on project teams and with external partners If you are passionate about applying your toxicology expertise to develop life-changing therapies across Muscle Biology research and development, we encourage you to apply for this exciting opportunity to make an impact as a key member of the Cytokinetics team.**Pay Range:**In the U.S., the hiring pay range for fully qualified candidates is $200,000-$221,000 USD Annual per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.*Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.***Please review our PRIOR to applying.**Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.Here are some ways to check for authenticity:* We do not conduct job interviews through non-standard text messaging applications* We will never request personal information such as banking details until after an official offer has been accepted and verified* We will never request that you purchase equipment or other items when interviewing or hiring* If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ************************************Please visit our website at:****Cytokinetics is an Equal Opportunity Employer** #J-18808-Ljbffr

A biopharmaceutical company in South San Francisco is seeking an Associate Director of Toxicology to manage and design non-clinical safety studies. This role involves collaborating across multi-functional teams and ensuring compliance with regulatory standards. The ideal candidate has a PhD in Toxicology, over 7 years of experience, and strong leadership skills. This position offers a competitive salary between $200,000 and $221,000 annually. #J-18808-Ljbffr

A global biotechnology company in San Rafael seeks a Director, Global CRM Business Lead to shape and execute its CRM strategy. The role requires a strong background in CRM systems, particularly Veeva and Salesforce, and at least 10 years of experience in the biotech or pharmaceutical industry. Key responsibilities include leading CRM initiatives across business units, enhancing customer engagement, and ensuring seamless integration. This position offers a competitive salary range of $178,900 to $245,960 plus additional benefits. #J-18808-Ljbffr

A leading biotech company in California is looking for a Director, Global CRM Business Lead to shape and execute the enterprise CRM strategy. Candidates should have over 10 years of CRM experience, particularly in the biotech or pharmaceutical sector, and be familiar with tools like Veeva and Salesforce. The role focuses on enhancing customer engagement through strategic leadership and effective data analysis. Competitive salary and a comprehensive benefits package included. #J-18808-Ljbffr

Opportunity Revolution Medicines is a clinical‑stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS‑addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. Key Responsibilities Operate as an ambassador of the company, establishing the organization as a trusted member of the healthcare community to all relevant stakeholders. Lead the development of effective strategic and promotional plans, shape launch strategy to align with full brand and portfolio strategy. Leverage deep understanding of oncology healthcare customers, including providers, key opinion leaders, patients, and market access stakeholders, to inform the brand strategic approach that drives customer behavior change and market performance. Lead implementation of brand/launch strategies through development of effective promotional materials for key customer segments and across multiple channels. Lead critical cross‑functional workstreams to support launch readiness and success. Leverage insights to inform stakeholder segmentation, channel mix, and targeting of customer segments. Ensure tactical execution is aligned to brand/launch strategies and stakeholder insights. Maintain deep knowledge of disease state, competitive, and market dynamics, informing potential pivots in strategic and executional approach as needed. Partner with internal stakeholders to develop and deliver impactful customer‑facing content. Partner with Analytics & Insights to shape market research, inform key performance metrics, and measure the effectiveness of marketing initiatives. Ensure management of agency of record relationships, workflow, and budgets. Ensure strategic and tactical plans meet compliance and regulatory guidelines and company policies. Deliver marketing operating expenses within budget. Travel as needed to home office and external meetings and conferences. Required Skills, Experience and Education Bachelor's degree required with at least 10 years of progressive commercial experience in a biotechnology and/or pharmaceutical company including strategic marketing and omnichannel marketing. Strong leadership skills, with the ability to work well cross‑functionally and influence across an organization at all levels. Proven track record of developing and executing effective marketing initiatives. Demonstrated analytical and problem‑solving skills, leading to the development of innovative marketing initiatives. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Strong interpersonal skills, with demonstrated ability to lead and influence cross‑functional partners. Exceptional communication skills, including excellent written and verbal communication skills; possesses a professional, proactive demeanor. Entrepreneurial mindset, with a tolerance for ambiguity, and a passion for helping cancer patients. Ability to represent Revolution Medicines well externally. Preferred Skills MBA Launch and customer‑facing experience Experience with targeted oncology products Experience in a smaller, rapidly growing company (#LI‑Hybrid #LI‑SS2) Base Pay and Benefits The base pay salary range for this full‑time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job‑related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Equal Opportunity Employer Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Privacy Statement Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by e‑mail or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. #J-18808-Ljbffr

Reporting to the Vice President of Operations, the Regional Director of Operations is accountable for driving operational consistency, efficiency, and performance across multiple ENT care centers within a defined market. This leader translates enterprise strategy into regional execution by managing performance outcomes, coaching managers, ensuring regulatory compliance, and sustaining a culture of excellence across all locations. Scope & Focus Scope: Multi-site management (5-15+ care centers or service lines) Focus Areas: Operational standardization, performance management, growth enablement, and people leadership Reports To: Vice President of Operations Direct Reports: Practice Managers, Supervisors, and select administrative leaders Key Responsibilities Operational & Financial Performance Implement standard workflows, SOPs, and policies consistently across all assigned sites in alignment with enterprise initiatives. Monitor KPIs including visit volumes, slot utilization, conversion rates, revenue per visit, patient satisfaction, and controllable expenses. Partner with Finance to develop and manage annual regional budgets; identify cost optimization and efficiency opportunities. Ensure accurate and timely reporting of operational performance through collaboration with the Data Analytics and Decision Support team. Conduct monthly site audits for compliance, facility standards, and patient safety readiness. Leadership & People Development Recruit, train, and coach Practice Managers to ensure accountability, empowerment, and leadership readiness. Establish clear management rhythms: Daily: Site-level huddles driven by Practice Managers Weekly: Regional review meetings focused on performance metrics and issue resolution Monthly: Regional scorecard reviews with VP of Operations Partner with HR and the VP of Operations on performance management, succession planning, and culture initiatives. Physician Relationship Management Serve as primary liaison between operational leadership and physicians. Lead regular physician alignment meetings to discuss performance metrics, service opportunities, and satisfaction drivers. Collaborate with physician leaders to implement growth programs (e.g., Allergy, Audiology, Vestibular, Sleep) and address workflow barriers. Support recruitment and onboarding of new providers, ensuring smooth operational integration and acclimation to MSO standards. Strategic Execution & Growth Lead operational rollout of new services, technologies, and acquisitions within assigned region. Partner with Business Development on due diligence, onboarding, and implementation phases of new practices. Oversee local market marketing efforts in collaboration with Marketing and Physician Relations to grow referral base and service adoption. Compliance, Risk & Quality Ensure compliance with all federal, state, and payer regulations; partner with Compliance Department for audits and follow-up. Enforce safety, facility, and quality standards through structured checklists and site visit programs. Lead remediation of audit findings and maintain readiness for internal or external inspections. MSO & Cross-Functional Collaboration Act as operational point person for rollout of MSO initiatives (e.g., new software, patient access changes, clinical integrations). Coordinate with centralized departments (Revenue Cycle, Credentialing, IT, Procurement, etc.). Cascade enterprise communications and ensure field readiness for new initiatives. Key Skills & Competencies Category Competencies Driving Results Accountability, prioritization, decision-making, problem-solving Operational Leadership Workflow design, resource allocation, data interpretation, standardization Interpersonal Relationship building, communication, conflict resolution, negotiation Change Leadership Adaptability, implementation discipline, continuous improvement mindset Cultural Leadership Modeling values, fostering engagement, developing people Qualifications • Bachelor's Degree required; Master's preferred. • 5-7 years in multi-site healthcare management (ENT, specialty, or ambulatory practice preferred). • Proven record of operational performance improvement and leadership of multi-location teams. • Strong analytical, communication, and organizational skills.

Astera is a nonprofit research organization pioneering unconventional scientific frontiers. Its latest initiative, Obelisk, is a large-scale, $50-100M/year research program aiming to engineer consciousness by integrating neuroscience, AI, and bioengineering to understand and digitally model the architecture of the human mind. Unlike traditional nonprofit research, Obelisk is structured and resourced to operate like a high-velocity, venture-backed research company with a clear engineering goal, attracting top talent from AI frontier labs (e.g., OpenAI, Neuralink) and leading academic institutions. With strong central operational support from Astera, Obelisk is positioned to scale rapidly, expanding from ~20 to 100+ interdisciplinary scientists and engineers over the next several years. Obelisk is led by Astera Co-founder Jed McCalebandDr. Doris Tsao, Chief Scientist. The new executive will partner closely with both to operationalize Obelisk's ambitious mission. Mission Hire a founding operational leader (COO) to architect, operationalize, and scale Astera Neuro -building the lab space, infrastructure, talent, and systems required to advance Astera's mission to explore the boundaries of human consciousness through neuroscience and AI. This leader will establish corporate-grade research operations, manage complex, cross-disciplinary programs, and ensure research is goal-oriented and well-directed. They will serve as both strategic integrator and organizational builder, transforming an early research vision into a world‑class scientific enterprise. Measures & Signals of Success Operational Readiness: Astera Neuro labs, vivarium, and facilities operational and compliant within 6-12 months. Team Scale‑Up: 50-100 top‑tier hires successfully recruited and integrated over the next 2‑3 years. Cross‑Functional Synergy: Coordinated progress between engineering and neuroscience groups; shared milestones achieved. Key Outcomes (12-24 Months) Operationalization & Scale‑Up Stand up the foundational operational systems for Astera Neuro, including lab infrastructure, regulatory compliance, and cross‑functional workflows. Establish and oversee a vivarium program (primate research), navigating local regulations, permitting, and community engagement. Define and execute a clear roadmap for facility buildout in Emeryville, CA. Recruitment & Organizational Growth Lead recruitment effort and onboard 50-100 world‑class neuroscientists, engineers, and supporting personnel across research and operations. Build an ambitious, mission‑driven culture that blends startup agility with scientific rigor to go after a challenging moonshot. Develop scalable processes for hiring, onboarding, and performance management tailored to Obelisk's interdisciplinary model. Cross‑Disciplinary Coordination Oversee Project Management function to create the connective tissue between neuroscience and engineering teams, ensuring rapid iteration and effective collaboration. Translate technical and scientific priorities into actionable operational plans and execute. Serve as the key communication hub across scientific, technical, and foundation leadership. Ensure seamless integration with Astera's central foundation teams (HR, Legal, Finance, Comms). Competencies Functional Expertise Helped build a startup as a founder or as part of the leadership team. 6+ years of leadership in complex research or technology organizations (AI, neuroscience, biotech, or advanced R&D). Proven success in rapidly scaling an organization from concept through multi‑lab operations. Skilled in program and project management, budget oversight, and operational design for hybrid scientific teams. Deep understanding of R&D infrastructure, lab buildouts, and vivarium setup and compliance is a plus. Leadership Attributes Visionary operational thinker who thrives in ambiguity and builds structure where none exists. Skilled technical communicator able to translate between scientific, engineering, and organizational contexts. Hands‑on builder-comfortable oscillating between strategic and tactical execution. Strong bias toward action. Cultural Alignment Deep belief in the existential importance of the mission; committed to ethical advancement of AI and neuroscience research. Thrives in unconventional, experimental environments blending tech and biology. Fast and nimble. Location: This role is in‑person in Emeryville, CA. Compensation: The successful candidate will receive a competitive compensation package commensurate with their experience. As a nonprofit organization, we're exempt from the H‑1B cap; visa sponsorship may be available for qualified candidates. #J-18808-Ljbffr