Associate Director jobs at Arcus Biosciences

The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally. Acts as a resource to the broader regulatory function, including mentorship of less experienced staff. Note: Regulatory Group works Pacific Time Zone hours. Responsibilities * Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success * Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets * Represents the regulatory function on cross-functional development teams * Plans, prepares, and reviews submissions to regulatory authorities including FDA, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA)/Biologic Licensure Application (BLA), and Marketing Authorization Application (MAA). * Works with regulatory submissions coordinator to develop submission timelines and work with cross-functional teams to planned objectives * Serves as the primary point of contact with FDA and other health authorities as applicable * Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of interaction * Manages all maintenance plans for regulatory investigative and marketing applications for assigned projects * Manage and provide guidance/training for regulatory staff members, including regular feedback and coaching for professional development * Develop relationships with external partners * Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs * Provides regulatory guidance and/or training to external departments * Prepares and revises internal procedures for continuous improvement * Manages activities performed by regulatory Education/Experience/Skills * Bachelor's degree in a life science required, PhD, PharmD or Master's degree preferred * A minimum of 8+ years in regulatory affairs with 12+ years in the biotech/pharma industry relevant to the respective regulatory function with experience in a leadership role. * Experience in oncology drug development a must. * Thorough knowledge of US and international regulations as they apply to pharmaceutical and biologic drug development * Previous experience managing development of INDs and other global clinical trial applications * Experience leading regulatory agency interactions, meetings * Ability to work in a cross-functional team environment and a flexible team-oriented perspective * Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills * Demonstrated problem solving abilities and conflict resolution skills * Proficiency in MS Office applications and internet researching * Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization * Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals * Other duties as assigned This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $215,000 - $275,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: ***************************** EOEArcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets #LI-EW1 #LI-Remote

HCT seeks an experienced nursing professionals to serve as Interim Director of Perioperative Services in California. Responsibilities include, but are not limited to: Manages and provides operational and nursing leadership and guidance, ensuring the quality of nursing care within preoperative, intraoperative, and postoperative areas. Provides patient care and acts as a resource person to the staff and assures patient care needs are met in the department. Demonstrates critical thinking skills and, in collaboration with other disciplines, surgeons, anesthesiologists, is able to coordinate unit activities, staffing plans and contributes to resolving inter and intra departmental problems. Assesses the quality of care delivered and provides input for staff mentoring/evaluation, staffing, hiring, performance management and general daily operation of the unit. Requirements: Education: Bachelor of Science in Nursing (BSN) required Experience: 5+ years of recent perioperative services management experience; Able to prioritize effectively according to department needs and ability to organize a large number of changing variables; Strong communication, diplomacy and persuasiveness, analytical ability, strong judgment and managerial skills License: California RN license required Certifications: AHA BLS, ACLS, PALS Computer Skills: Information systems experience (EPIC) and Microsoft Office suite Expenses covered while on assignment including housing, airfare, and rental car.

HCT seeks an experienced nursing professionals to serve as Interim Director of Perioperative Services in California. Responsibilities include, but are not limited to: Manages and provides operational and nursing leadership and guidance, ensuring the quality of nursing care within preoperative, intraoperative, and postoperative areas. Provides patient care and acts as a resource person to the staff and assures patient care needs are met in the department. Demonstrates critical thinking skills and, in collaboration with other disciplines, surgeons, anesthesiologists, is able to coordinate unit activities, staffing plans and contributes to resolving inter and intra departmental problems. Assesses the quality of care delivered and provides input for staff mentoring/evaluation, staffing, hiring, performance management and general daily operation of the unit. Requirements: Education: Bachelor of Science in Nursing (BSN) required Experience: 5+ years of recent perioperative services management experience; Able to prioritize effectively according to department needs and ability to organize a large number of changing variables; Strong communication, diplomacy and persuasiveness, analytical ability, strong judgment and managerial skills License: California RN license required Certifications: AHA BLS, ACLS, PALS Computer Skills: Information systems experience (EPIC) and Microsoft Office suite Expenses covered while on assignment including housing, airfare, and rental car.

HCT seeks an experienced nursing professionals to serve as Interim Director of Perioperative Services in California. Responsibilities include, but are not limited to: Manages and provides operational and nursing leadership and guidance, ensuring the quality of nursing care within preoperative, intraoperative, and postoperative areas. Provides patient care and acts as a resource person to the staff and assures patient care needs are met in the department. Demonstrates critical thinking skills and, in collaboration with other disciplines, surgeons, anesthesiologists, is able to coordinate unit activities, staffing plans and contributes to resolving inter and intra departmental problems. Assesses the quality of care delivered and provides input for staff mentoring/evaluation, staffing, hiring, performance management and general daily operation of the unit. Requirements: Education: Bachelor of Science in Nursing (BSN) required Experience: 5+ years of recent perioperative services management experience; Able to prioritize effectively according to department needs and ability to organize a large number of changing variables; Strong communication, diplomacy and persuasiveness, analytical ability, strong judgment and managerial skills License: California RN license required Certifications: AHA BLS, ACLS, PALS Computer Skills: Information systems experience (EPIC) and Microsoft Office suite Expenses covered while on assignment including housing, airfare, and rental car.

HCT seeks an experienced nursing professionals to serve as Interim Director of Perioperative Services in California. Responsibilities include, but are not limited to: Manages and provides operational and nursing leadership and guidance, ensuring the quality of nursing care within preoperative, intraoperative, and postoperative areas. Provides patient care and acts as a resource person to the staff and assures patient care needs are met in the department. Demonstrates critical thinking skills and, in collaboration with other disciplines, surgeons, anesthesiologists, is able to coordinate unit activities, staffing plans and contributes to resolving inter and intra departmental problems. Assesses the quality of care delivered and provides input for staff mentoring/evaluation, staffing, hiring, performance management and general daily operation of the unit. Requirements: Education: Bachelor of Science in Nursing (BSN) required Experience: 5+ years of recent perioperative services management experience; Able to prioritize effectively according to department needs and ability to organize a large number of changing variables; Strong communication, diplomacy and persuasiveness, analytical ability, strong judgment and managerial skills License: California RN license required Certifications: AHA BLS, ACLS, PALS Computer Skills: Information systems experience (EPIC) and Microsoft Office suite Expenses covered while on assignment including housing, airfare, and rental car.

Senior Director, Legal Counsel page is loaded## Senior Director, Legal Counsellocations: South San Francisco, Californiatime type: Full timeposted on: Posted 30+ Days Agojob requisition id: R274Cytokinetics 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.**Responsibilities*** This role is expected to have critical understanding of complex contracts and strong knowledge of key provisions of such agreements such as indemnities, limitations of liability, intellectual property, warranties and covenants, regulatory, termination and other critical contract negotiation issues.* Agreements will include indentures, lease agreements, clinical trial agreements, pharmaceutical license agreements, master service agreements, software license agreements and supply and wholesaler arrangements.* Lead certain general corporate contracts - drafting, negotiating and reviewing certain corporate contracts, as needed and knowledge of contract-related systems.* Independently provide leadership on cross-functional teams, identify legal issues, provide legal options and analysis of possible legal solutions, and give recommendations for addressing critical issues so that business and legal objectives are met.* May also provide support and advice to G&A departments and investor relations.* Manage outside counsel effectively and efficiently, and consistent with applicable budgets. Work creatively with outside counsel to minimize fees and costs.**Qualifications*** JD degree* Admitted to at least one state bar. Admitted to California bar or admitted as Registered In-House Counsel in California is a plus* Minimum of 10 years of experience as in-house counsel in a biotechnology, pharma or healthcare company or a combination of in-house at large public company and/or nationally recognized law firm specializing in the area of interest* Strong working knowledge of U.S. securities laws and NASDAQ requirements. Experience with securities filings of public companies in the life science industry or strong experience in completing public Merger and Acquisition activities* Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility, combined with strong analytical and problem-solving skills* A sophisticated existing understanding of financial regulations* An ability to operate independently* Excellent communication skills, both oral and written* Intellectual curiosity and a willingness to take responsibility for novel and emerging areas of regulation* Well-organized and hardworking, with the ability to manage numerous projects simultaneously under deadline pressure* Excellent analytical skills, with a strong ability to draft and review legal documents, analyze legal advice and apply legal advice to business needs* Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper legal standards* Team-oriented, sound judgment, self-motivation and willingness to take initiative#LI-HYBRID**Pay Range:**In the U.S., the hiring pay range for fully qualified candidates is $333,000 - $368,000 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 leading biopharmaceutical company in South San Francisco is seeking a Senior Director, Legal Counsel to oversee complex contract negotiations and provide legal guidance for corporate activities. The ideal candidate will have over 10 years of experience, a JD degree, and strong knowledge of U.S. securities laws. This role requires excellent communication and analytical skills, alongside the ability to work independently in a fast-paced environment. #J-18808-Ljbffr

The Home Health Executive Director is responsible for modeling the Compassus values of Compassion, Integrity, Excellence, Teamwork, and Innovation and for promoting the Compassus philosophy, using the 6 Pillars of Success as the foundation. S/he is responsible for upholding the Code of Ethical Conduct and for promoting positive working relationships within the company, among all departments, and all external stakeholders. The Home Health Executive Director oversees and manages the day-to-day operations of the program and is a positive motivator for colleagues, patients, and the community. S/he works in union with the Regional Vice President to ensure a quality business operation. Position Specific Responsibilities Hands on leader who supervises, and provides coaching and education for staff. Fills in for any position in the program as needed. Reviews profit and loss statements, anticipates any risks to the business line, and meets and exceeds budgetary control. Explores resources of revenue improvement and expense reduction. Works in conjunction with the Director of Clinical Services and the Strategic Development team for growth strategies. Works as a community care consultant in conjunction with Strategic Development and/or Home Health Care Consultants. Maintains a positive image in the community. Creates and reviews year strategic plan. Responsible for all day-to-day operations for home health program(s) in a geographic coverage area. Maintains low service failure occurrences and/or handles service failures as a extreme priority. Maintains high patient and team member satisfaction. Partners with Human Resources as appropriate in recruitment, hiring, discipline, and discharges to ensure legality and consistency with policies and procedures. Creates a positive climate in which each team member feels highly valued, involved, and engaged; productivity is fostered; quality and service are promoted; and our “employer-of-choice” reputation is advanced Champions regular, effective communications in one-on-one and group settings, using both listening and speaking skills to promote deeper understanding, collaborative problem solving, and team effort towards a common goal, thereby optimizing team member engagement and retention. Maintains policies, procedures, and licensures in accordance with the company, federal and state requirements. Reviews daily operating reports. Runs daily morning stand up and management meetings. Integrates change management strategy when planning changes. Completes reporting as needed for month end close, or other purposes. Reviews patient satisfaction survey results. Completes program score cards monthly. Makes or delegates post-admissions calls. Education and/or Experience Bachelor's degree in Health Care Administration, Business Administration, or a related Human Services field strongly preferred. At least two (2) years of experience in the healthcare industry required. Total of five (5) years supervisory experience required. Preferred Registered Nurse with Oasis and HCHB experience #LI-KS1

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary We are seeking a talented and motivated Global Regulatory Lead (GRL) to join our growing Research and Development organization at the Associate Director/Director level. As a key member of the core product development team, you will have the opportunity to provide strategic directions to ensure successful product development and approval in alignment with company objectives. In advancing several product candidates into clinical stage, CRISPR Therapeutics will offer the right individuals the opportunity to devise and implement creative global regulatory development strategies to bring novel products to patients as quickly, robustly and efficiently as possible, and to shape the regulatory framework in which we operate. The position provides an excellent opportunity to apply current knowledge and gain experience in the fast growing and advancing field of gene and cellular therapies. As the company grows, you will have the opportunity to contribute to building the organization and further advance your leadership position. Responsibilities Provide strategic vision and innovative scientific and regulatory leadership in defining a comprehensive science-based, solution-oriented global regulatory development strategy for assigned projects to achieve high quality and timely product registration and effective regulatory agencies interactions aligned with stakeholders needs. Pro-actively establish and maintain high-quality working relationships with regulatory agencies as appropriate for assigned therapeutic areas and products. Monitor and assess impact of relevant global regulations and the evolving regulatory, scientific and competitive environment. Represent Global Regulatory Affairs on assigned core product development teams and other relevant teams and/or governance bodies, including external alliances and partnerships. Provide regulatory expertise and guidance to product development teams and other functions of the company as needed, including by applying appropriate competitive decision making. Provide regulatory direction in product development to align medical need with business objectives in the context of available and expected scientific data, and regulatory guidance and precedent. Lead the planning and implementation of global regulatory filings (IND/CTAs, BLAs). Oversee all submission activities and regulatory writing for regulatory documentation including but not limited to meeting briefing packages, requests for special designations, INDs, BLA/MAAs and routine submissions. Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents). Present regulatory plans, risk assessments and strategies, pertaining to the assigned project(s), including innovative strategic options which communicate the associated risks. Minimum Qualifications A bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science. Prior regulatory experience with a demonstrated track record of significant accomplishments: Associate Director: 12+ Years of relevant experience with a bachelor's degree 10+ Years of relevant experience with an advanced degree Director: 15+ Years of relevant experience with a bachelor's degree 12+ Years of relevant experience with an advanced degree Candidates must have a thorough knowledge and understanding of pharmaceutical and/or biological product development and regulatory requirements for product development and approval in more than one key region (i.e. EU, US, New Zealand, or Australia). Experience interfacing with regulatory agencies and proven skill at developing, communicating and implementing successful global regulatory strategies. Demonstrated ability to communicate and write clearly, concisely, and effectively Experience driving documents through from start to finish with tight timelines and cross-functional study teams Strong analytical skills and ability to interpret and present complex data clearly Independently motivated, and good problem-solving ability Preferred Qualifications An advanced degree (MS/MBA, PhD or MD) Current experience developing new product regulatory strategies including submissions and approvals from early development through marketing applications. Working knowledge of cellular and gene therapies or biologics development and manufacture, and relevant global regulatory environment. Detailed knowledge of requirements for preparation of key regulatory documents for INDs, CTAs, BLAs and annual reports. Prior preclinical or clinical regulatory foundation. Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred Experience working in a small biotech environment Detailed knowledge of requirements for preparation of key clinical and regulatory documents for INDs, CTAs, BLAs and annual reports Competencies • Collaborative - Openness, One Team • Undaunted - Fearless, Can-do attitude • Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. • Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Assoicate Director: Base pay range of $180,000 to $205,000+ bonus, equity and benefits Director: Base pay range of $198,000 to $225,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary CRISPR Therapeutics is searching for an Associate Director, Pharmacovigilance Operations to manage global case processing, safety reporting, and vendor oversight for our clinical programs. The Associate Director, Pharmacovigilance (PV) Operations will contribute to a full range of pharmacovigilance activities: overseeing the management of individual case safety reports (ICSRs), supporting PV vendors, and safety governance. The successful candidate will work cross functionally to ensure robust and compliant safety operations. Responsibilities * Ensure that Individual Case Safety Reports (ICSR) for assigned products are triaged, processed and submitted/distributed per global requirements and applicable SOPs * Perform ICSR assessments (seriousness, expectedness, causality) for clinical trial safety reports, including review of Analysis of Similar Events, where applicable * Manage key Pharmacovigilance governance meetings such as Safety Governance Board * Review ICSRs for completeness and accuracy; draft queries and ensure appropriate follow-up * Ensure the continuous oversight of the global safety database activities and any PV vendor with appropriate governance implementation * Review key performance indicators in support of pharmacovigilance quality and vendor oversight * Represent PV/Safety on clinical study teams. collaborate cross-functionally to deliver on PV and study objectives * Lead or contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials * Lead, manage and contribute to preparation and review of periodic reports (e.g. DSUR) * Participate in SAE reconciliation, coding reviews and other study team activities * Participate in protocol development to ensure effective collection of safety data. Review and provide medical content and analysis, as needed, for regulatory documents and key study-related documents (e.g. ICF, SMC/IDMC Charters, clinical study reports) * Develop and deliver PV training materials including for Investigator Meetings or Site Initiation Visits * Support PV-related inspection and audit activities * Lead or contribute to the development of PV processes and procedures to assure completeness and accuracy of safety data collection and ensure compliance with all relevant regulations. * Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed. Minimum Qualifications * Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science. * Prior pharmacovigilance experience with a demonstrated track record of significant accomplishments: * 12+ Years of relevant experience with a bachelor's degree * 10+ Years of relevant experience with an advanced degree * Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments * Knowledge and understanding of global pharmacovigilance regulatory requirements and general regulatory * expectations * Advanced knowledge of common data processing software and safety database systems * Demonstrated knowledge of pharmacovigilance and risk management including development * Excellent written and verbal communication skills, with ability to collaborate cross-functionally Preferred Qualifications * Advanced degree in a scientific field or healthcare professional degree (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent) * Prior experience working for a cell or gene therapy company Competencies * Collaborative - Openness, One Team * Undaunted - Fearless, Can-do attitude * Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. * Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Associate Director: Base pay range of $180,000 to $210,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary CRISPR Therapeutics is searching for an Associate Director, Pharmacovigilance Operations to manage global case processing, safety reporting, and vendor oversight for our clinical programs. The Associate Director, Pharmacovigilance (PV) Operations will contribute to a full range of pharmacovigilance activities: overseeing the management of individual case safety reports (ICSRs), supporting PV vendors, and safety governance. The successful candidate will work cross functionally to ensure robust and compliant safety operations. Responsibilities Ensure that Individual Case Safety Reports (ICSR) for assigned products are triaged, processed and submitted/distributed per global requirements and applicable SOPs Perform ICSR assessments (seriousness, expectedness, causality) for clinical trial safety reports, including review of Analysis of Similar Events, where applicable Manage key Pharmacovigilance governance meetings such as Safety Governance Board Review ICSRs for completeness and accuracy; draft queries and ensure appropriate follow-up Ensure the continuous oversight of the global safety database activities and any PV vendor with appropriate governance implementation Review key performance indicators in support of pharmacovigilance quality and vendor oversight Represent PV/Safety on clinical study teams. collaborate cross-functionally to deliver on PV and study objectives Lead or contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials Lead, manage and contribute to preparation and review of periodic reports (e.g. DSUR) Participate in SAE reconciliation, coding reviews and other study team activities Participate in protocol development to ensure effective collection of safety data. Review and provide medical content and analysis, as needed, for regulatory documents and key study-related documents (e.g. ICF, SMC/IDMC Charters, clinical study reports) Develop and deliver PV training materials including for Investigator Meetings or Site Initiation Visits Support PV-related inspection and audit activities Lead or contribute to the development of PV processes and procedures to assure completeness and accuracy of safety data collection and ensure compliance with all relevant regulations. Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed. Minimum Qualifications Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science. Prior pharmacovigilance experience with a demonstrated track record of significant accomplishments: 12+ Years of relevant experience with a bachelor's degree 10+ Years of relevant experience with an advanced degree Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments Knowledge and understanding of global pharmacovigilance regulatory requirements and general regulatory expectations Advanced knowledge of common data processing software and safety database systems Demonstrated knowledge of pharmacovigilance and risk management including development Excellent written and verbal communication skills, with ability to collaborate cross-functionally Preferred Qualifications Advanced degree in a scientific field or healthcare professional degree (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent) Prior experience working for a cell or gene therapy company Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Associate Director: Base pay range of $180,000 to $210,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

The Our Place Associate Director is a key leadership position responsible for directing the day-to-day operations of Our Place , a multi-service center in West Oakland serving people experiencing homelessness, including co-occurring disorders, within a safe, community focused setting. The site provides integrated services, Monday - Friday, including case management, recovery support, group and individual therapy, medical care, acupuncture, hygiene services, and hot meals. The Associate Director provides strategic and operational leadership to ensure high-quality, trauma-informed, and client-centered services, including individual and group therapy. This role supervises diverse staff, many with lived experience, ensures compliance with program and contract requirements, manages multiple funding sources (including federal, state, and private grants and insurance billing) and fosters strong community partnerships. The Associate Director works collaboratively across LifeLong Medical Care's Homeless Services Department, as well as with LifeLong Medical Care's Behavioral Health Department, to ensure consistency of practice, sustainability of services, a nurturing and supportive work and client environment, and positive client outcomes. About us: As a Federally Qualified Health Center in Northern California with over 45 years of dedicated service to the community, LifeLong serves over 66,000 patients in the East Bay Area's socio-economically underserved regions. We provide medical, dental, behavioral health, and school-based services at more than 15 primary care sites across Oakland, Berkeley, and West Contra Costa County. From opening a residential respite program for homeless persons discharged from hospital to offering free testing to the community, we are innovative and responsive to our times' social and medical needs. We provide an inclusive workplace that promotes and values diversity and with which our patients can identify. To this end, we seek candidates who reflect the diversity of the East Bay communities we serve. Benefits: We offer a competitive annual salary of $105,000-$132,000 for LCSW/LMFT/LPCC, depending on years since licensed, and excellent benefits: medical, dental, vision, Flexible Spending Accounts, dependent and domestic partner coverage, 403(b) retirement savings plan, and loan repayment programs. LifeLong is a qualified site for federal and state loan repayment programs (HPSA score is 16). Acceptance rates may vary year to year based on funding levels and the number of applicants. Responsibilities Essential Duties and Responsibilities Program Leadership & Oversight Direct the daily operations of Our Place to ensure safe, welcoming, and effective service delivery recognizing the importance a sense of community and belonging plays for both clients and staff Lead recruitment, onboarding, training, and professional development efforts for Our Place staff. Develop, implement, and evaluate policies, procedures, and workflows to support efficient, high-quality operations. Ensure services are aligned with best practices in homeless services, harm reduction, behavioral health, and recovery support. Lead site-based strategic planning efforts and contribute to the broader Homeless Services Department's goals. Service Provision Provides comprehensive psychosocial assessments, mental health diagnoses, treatment plans and implements short and longer-term counseling using appropriate modalities for patients with issues such as depression, anxiety, trauma, grief/loss, addiction, domestic violence, behavioral health problems, and psychosocial stressors. Provide individual and group therapy to a small number of clients Staff Leadership & Development Provide regular direct administrative supervision to program/operations managers, clinical supervisors, and front-line staff. Support staff development through training, coaching, mentoring, and performance evaluations. Foster a culture of accountability, equity, collaboration, and professional growth. Ensure adequate staffing levels and support staff wellness in a high-volume, high-need environment. Fiscal & Contract Management Oversee site budgets and staff productivity to ensure effective stewardship of financial resources. Support management of federal, state, county, and private contracts, ensuring timely reporting, invoicing, grant activities/deliverables, and compliance with regulations, in coordination with LMC Grants staff. Track and monitor program performance metrics to meet funder and organizational requirements in collaboration with the Homeless Services Quality Director. Community & Stakeholder Engagement Cultivate and maintain strong relationships with community partners, funders, government agencies, and referral sources. Represent Our Place and LifeLong Medical Care in collaborative meetings, advisory groups, and public forums. Advocate for the needs of people experiencing homelessness and contribute to system-level improvement efforts. Quality Improvement & Compliance Ensure compliance with federal, state, and local laws, as well as internal policies and procedures. Implement quality improvement initiatives that advance equity, client outcomes, and staff satisfaction. Monitor program fidelity, data collection, and documentation standards across all service areas. Qualifications Required Licensed Clinical Social Worker (LCSW), Licensed Marriage and Family Therapist (LMFT), or Licensed Professional Clinical Counselor (LPCC). Minimum of 5 years of progressively responsible experience in nonprofit or human -services leadership roles, with at least 1 year in program or operations management. Experience working with people experiencing homelessness, behavioral health challenges, and substance use disorders. Demonstrated experience managing budgets, contracts, and compliance with complex funding sources (federal, state, county, and private). Strong staff supervision skills with experience managing multidisciplinary teams, including people with lived experience. Commitment to trauma-informed, harm reduction, and equity-focused practices. Preferred Experience leading services in a high-volume drop-in center, homeless shelter, or recovery program. Knowledge of Alameda County's homeless and behavioral health service systems.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Associate Director, Principal Scientist, Toxicology will play a critical role in driving the nonclinical safety assessment of small and large molecule therapeutics within Denali's pipeline. This position involves conducting and managing toxicology studies, analyzing and interpreting safety data, and collaborating with cross-functional teams to advance drug candidates through various stages of development. This role serves as a functional leader for the Toxicology team and includes people leadership accountability for one or more Toxicologists. Key Accountabilities/Core Job Responsibilities: Nonclinical Toxicology Support: Design and implement nonclinical toxicology programs and strategies to evaluate the safety of Denali's therapeutic candidates. Conduct and oversee non-GLP and GLP toxicology studies, ensuring adherence to regulatory standards. Data Analysis and Reporting: Analyze, interpret, and summarize toxicology data to support safety evaluations. Prepare and present safety data to internal project teams and senior management, contributing to informed decision-making. Regulatory Support: Assist in the preparation and authoring of regulatory documents related to nonclinical safety assessments. Ensure compliance with relevant regulatory guidelines and standards throughout all stages of toxicology studies. Collaboration and Cross-Functional Work: Work closely with colleagues in Research and Development, providing toxicology expertise to support cross-functional project teams. Participate in project meetings, offering insights and recommendations to advance safety assessment strategies. Investigative Efforts: Support investigative efforts into mechanisms of toxicity and contribute to the development of safer therapeutic candidates. Assist in developing and implementing de-risking strategies for drug discovery and development projects. People Leadership: Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications/Skills: PhD OR Advanced Degree in Toxicology, Biology, Pharmacology or related scientific discipline. At or near 7 plus years of relevant work experience inclusive of postdoctoral work; OR MS with 10+ years of relevant work experience. Experience with biologics and oligonucleotides preferred Strong scientific background and scientific aptitude Excellent critical thinking and scientific skills Ability to work effectively and collaboratively on cross-functional projects teams, and demonstrated can-do attitude Ability to work in a fast-paced environment Excellent oral, presentation, and written communication skills Salary Range: $203,000.00 to $240,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Associate Director, Principal Scientist, Toxicology will play a critical role in driving the nonclinical safety assessment of small and large molecule therapeutics within Denali's pipeline. This position involves conducting and managing toxicology studies, analyzing and interpreting safety data, and collaborating with cross-functional teams to advance drug candidates through various stages of development. This role serves as a functional leader for the Toxicology team and includes people leadership accountability for one or more Toxicologists. Key Accountabilities/Core Job Responsibilities: Nonclinical Toxicology Support: * Design and implement nonclinical toxicology programs and strategies to evaluate the safety of Denali's therapeutic candidates. * Conduct and oversee non-GLP and GLP toxicology studies, ensuring adherence to regulatory standards. Data Analysis and Reporting: * Analyze, interpret, and summarize toxicology data to support safety evaluations. * Prepare and present safety data to internal project teams and senior management, contributing to informed decision-making. Regulatory Support: * Assist in the preparation and authoring of regulatory documents related to nonclinical safety assessments. * Ensure compliance with relevant regulatory guidelines and standards throughout all stages of toxicology studies. Collaboration and Cross-Functional Work: * Work closely with colleagues in Research and Development, providing toxicology expertise to support cross-functional project teams. * Participate in project meetings, offering insights and recommendations to advance safety assessment strategies. Investigative Efforts: * Support investigative efforts into mechanisms of toxicity and contribute to the development of safer therapeutic candidates. * Assist in developing and implementing de-risking strategies for drug discovery and development projects. People Leadership: * Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications/Skills: * PhD OR Advanced Degree in Toxicology, Biology, Pharmacology or related scientific discipline. * At or near 7 plus years of relevant work experience inclusive of postdoctoral work; OR MS with 10+ years of relevant work experience. * Experience with biologics and oligonucleotides preferred * Strong scientific background and scientific aptitude * Excellent critical thinking and scientific skills * Ability to work effectively and collaboratively on cross-functional projects teams, and demonstrated can-do attitude * Ability to work in a fast-paced environment * Excellent oral, presentation, and written communication skills Salary Range: $203,000.00 to $240,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director, Device Engineering is a detail-oriented and results-driven individual with a strong understanding of product design, pharmaceutical device regulations, GMP standards and workload management. This individual is responsible for driving commercial readiness and managing the life cycle of drug device combination products. This role will work closely with Global Operations, Development, Quality, Procurement, Regulatory, Packaging Engineering, consultants and outside vendors. Responsibilities Develop and oversee design control system and business strategies to support commercial device/combination drug development. Create and execute project plans and schedules. Develop, execute, and manage documents for product design, specifications, development plans, characterization plans, verification/validation plans, risk management, human factors and other related product development documents. Author or Review/Approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Participate in design reviews, provide critical design for manufacturing input to ensure product designs are robust for manufacturing. Support site and vendor risk assessments, develop and maintain pFMEAs, and develop control plans to mitigate risks. Ensure that all product functional requirements are translated into manufacturing requirements and process controls. Provide technical support for CMO/vendor sourcing activities. Sponsor and/or lead projects, initiatives, and process improvements falling under device engineering business systems scope to build for the future. Requirements Bachelor's Degree in Engineering or other field related to the essential duties of this role and 10+ years of increasing responsibility in medical device industry, focused on engineering processes and procedures. (or a Master's Degree with 8+ years of experience, or a Doctorate Degree with 5+ years of experience.) Strong MS Office skills (Outlook, Excel, PowerPoint, and Word) Excellent verbal and written communication skills A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead Ability to work prolonged periods at a desk and working on a computer. Aptitude for independently resolving competing priorities in a fast-paced environment Preferred: Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. Experience with product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements. Wisconsin pay range $170,000-$190,000 USDCalifornia pay range $180,000-$200,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director, Packaging Engineering is responsible for the technical aspects of commercial packaging for drug substance, drug product, primary container/closure, and final product presentations including secondary/tertiary packaging/configuration for shipment. This position will lead the design and development of packaging for commercialization of new products through the design transfer process, as well as manage changes to existing products. This role will work closely with Global Operations, Development, Quality, Procurement, Regulatory, Device Engineering, and outside vendors. Responsibilities Create and implement long-term packaging development strategy. Create and execute project plans and schedules. Lead and execute packaging strategies on projects, working with internal and external stakeholders to develop packaging designs, materials, and processes for new products. Create and maintain packaging design and packaging validation programs compliant with packaging laws, industry-recognized standards, and test methods. Develop, execute, and manage documents for packaging specifications, development plans, testing protocols, qualification/validation plans, risk management, and other related packaging development documents. Initiate/review change controls, deviations, CAPAs, and risk assessments related to packaging components/configuration within QMS in collaboration with Quality. Support root cause analysis activities. Drive continuous improvement in the packaging processes from project initiation through launch as well as life cycle management in alignment with regulatory and commercial manufacturing requirements. Provide technical support for commercial packaging vendor sourcing activities. Sponsor and/or lead projects, initiatives, and process improvements falling under packaging engineering business systems scope to build for the future. All other duties as assigned. Requirements Bachelor's Degree in Engineering or other field related to the essential duties of this role and 10+ years of increasing responsibility in pharmaceutical industry, focused on packaging processes and procedures. (or a Master's Degree with 8+ years of experience, or a Doctorate Degree with 5+ years of experience.) Strong problem solving, risk assessment, and risk management skills and capable of working on multiple projects in a deadline driven environment. Exhibits excellent interpersonal communication, project management, collaboration, and analytical skills. Strong MS Excel, PowerPoint, and Word skills. Experience using Smartsheet or other work management software. Exhibits creativity in adapting to changing situations, development of contingency plans and comfortable with making decisions. Preferred: Expertise in testing, validation, packaging laws, industry-recognized standards and test methods (e.g., ASTM, ISTA, ISO, USP), regulations (e.g., ISO 11607, 21 CFR 820), and risk management to identify and recommend design improvements that address deficiencies. Experience developing and commercializing new products on cross-functional teams. Experience with cold chain products. Wisconsin pay range $170,000-$190,000 USDCalifornia pay range $180,000-$200,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

100% employer health plan for employees and their eligible dependents Unique benefit offerings that are partially or 100% employer-paid Rich and varied retirement plans and the ability to participate in multiple plans. Generous paid time off plans Role Overview: Alameda Health System is hiring! The Director of Utilization Management holds a critical role encompassing operational oversight, strategic planning, compliance, and collaboration. Their responsibilities span from managing admissions to ensuring clean claims, identifying trends, and optimizing resource utilization. This role supports patient care coordination, fosters physician collaboration, and aligns with organizational objectives while adapting to ad hoc duties as needed. In essence, they orchestrate efficient utilization management to deliver high-quality patient care. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: Following are the duties performed by employees in this classification. However, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Lead and manage a team of utilization review professionals providing guidance, training, and performance evaluations. Monitor and evaluate the utilization of healthcare services, including appropriateness, efficiency, and medical necessity of treatments and procedures. Analyze data and generate reports on utilization trends, outcomes and quality indicators to support decision-making and process improvement initiatives. Reports to appropriate committees. Manage quality of performance criteria, policies and procedures, and service standards for the utilization management operations. Evaluate utilization reviews and determine program improvements. Develop and implement utilization review policies and procedures in accordance with industry standards and regulatory requirements. Direct and coordinate data gathering and record keeping legally required by federal and state agencies, the Joint Commission, and hospital policies; participates in the risk mitigation, process of implementing new or revised processes, and projects Foster effective communication and collaboration with internal departments, external agencies, and insurance providers to facilitate the utilization review process. Participate in interdisciplinary committees and meetings to contribute to the development and implementation of quality improvement initiatives. Oversees the secondary review process; actively appeals denied cases when necessary and assists physicians with appeals. Maintains minimal denial rates by Medicare, MediCal, private and contracted payers through appropriate direction of utilization practices; assists physicians and hospital personnel in understanding UM matters. Perform all other duties as assigned. Prepares cost analysis reports and other data needed for the preparation of the departmental budget. Provides in-house educational programs as needed for both staff and physicians. Responsible for the recruitment, orientation, evaluation, counseling and disciplinary action of UM and administrative staff. Serves as a content expert to staff and internal departments and external partners; networks with other hospitals, nursing organizations, and professional organizations to keep abreast of changes within the profession. MINIMUM QUALIFICATIONS: Required Education: Bachelor's degree in Nursing Preferred Education: Master's degree in Nursing Required Experience: Three years of utilization review experience. Health insurance company and/or acute care hospital, post-acute and psych; three years of InterQual and/or MCG. Strong clinical nursing background. Required Licenses/Certifications: Valid license to practice as a Registered Nurse in the State of California. Preferred Licenses/Certifications: UM / CM certifications Highland General Hospital SYS Utilization Management Full Time Day Nursing FTE: 1

The Director of Field Operations is responsible for the execution of the field operations team, primarily located in the mid to southern CA and Portland, OR. The Director will be tasked with identifying goals, enabling tactics, and tracking metrics that lead to the optimization of achieved profitability, safety/compliance, customer satisfaction and associate acquisition, growth and retention. This individual must possess a strong leadership presence, with an operational acumen and analytical approach. Major Duties & Responsibilities Essential Functions Execution of tactical plans in line with the Corporate Vision that achieve the growth objectives of the business, Ability to thrive in a fast-moving environment (Pace setter for rapid development and growth) Key contributor to all field operations decision-making processes Direct the day-to-day operations of a geographically remote and broad-based team Participate in the implementation of business strategies to effectively achieve service fulfillment, inventory and financial objectives. Refine and develop the Logistics, Inventory and Field Service capability, infrastructure, policies, procedures, and processes and ensuring they are maintained and adhered to in accordance with Company and regulatory & quality systems, policies, and guidelines. Reconcile financial and operational results to ensure all information is correct. Take corrective action, as necessary. Provide management information reports. Act in a collaborative capacity with all departments. Establish priorities and make workflow decisions. Assure that our contractual commitments are met. Lead warehouse flow/set-up/RFI and other initiatives Analyze business patterns to ensure optimal location and type of resources (staffing, facilities, inventory, vehicles, etc.) to meet shifting customer demand. Perform and ensure quality completion of People Management strategy and systems. Understand, manage, and direct the effective implementation of new equipment and technologies. Ensure effective utilization of existing equipment and systems. Routine travel and visits to Equip Tech Centers, along with frequent customer communication and visits to assess customer satisfaction and staff competency. Perform assigned stretch assignments to develop professionally. Supervisory Responsibilities: Lead Service Fulfillment function, including staffing, processes and procedures. Working in team environment with the Joerns executive members, Company's Business Units and third parties, to implement the go-to-market strategies for services and rental products. Develop annual operating budgets for Logistics, Inventory and Field Service groups Contribute to the develop cost optimized strategies, which meet customer and, quality requirements which both maintain existing business and support growth activities. Contribute to the develop and execute strategies to meet financial goals and objectives. Develop, implement, review, and adjust a robust management process for Logistics, Inventory and Field Service to ensure successful attainment of Joerns Service Group relevant goals and objectives Direct and Monitor core Logistics, Inventory and Field Service performance, including delivery against service level agreements and cost objectives. Skilled in management development, employee development and talent identification to create an associate resource to fuel growth. Set and execute on a clearly stated vision, direction & goals for the function as well as to lead people for delivery of team/individual performance goals Establish and use metrics that tie to Joerns Service Group priorities to drive behavior change and achieve goals. Implement and maintain appropriate systems for measuring necessary aspects of operational management and development. Monitor, and act on operational issues, opportunities and development plans and achievements within agreed formats and timescales Direct and develop direct reporting staff Manage and control departmental expenditure within agreed budgets Develop active Customer Fulfillment and Logistics processes and systems which efficiently dispatch and execute activities ensuring Service Delivery performance goals are achieved and maintained. Liaise with other functional/departmental managers to understand all necessary aspects and needs of operational and management development, and to ensure they are fully informed of objectives, purposes and achievements Maintain awareness and knowledge of contemporary operational and management development theory and methods and provide suitable interpretation to directors, managers, and staff within the organization Contribute to the evaluation and development of operational and management strategy and performance in cooperation with the management and executive teams Ensure activities meet organizational requirements for quality management, health and safety, legal stipulations, environmental policies, and general duty of care. Perform in a lawful and ethical manner, as referenced in the corporate ethics policy Evaluate and upgrade the Company's Service Logistics, Inventory and Field Service (LIFS) function, which includes the people, operational and financial processes, technical systems, and internal and external relations. LIFS Strategy - Develop the right Logistics, Inventory and Field Service strategy that supports and meets Services Logistics Group's performance objectives, and customer expectations. LIFS Technology - Evaluate, determine, and deploy the required technology strategy for optimal Services performance and metrics Required Education 4-year degree in Management or relevant business background Required Skills & Experience At least 5 years operations management experience Must have excellent leadership, communication, and management skills, in a fast-paced high growth environment with expertise in allocation, distribution, inventory and logistics. Ability to organize, lead, motivate, and care for all personnel and customer issues. Must have experience managing and/or leading multisite field/logistic operations with a strong background in budgets and cost management. Ability to travel and manage seamlessly from a remote site; Travel requirement 65-75% Ability to manage customer expectations, lead direct reports and be flexible with both while meeting objectives. Ability to work independently, exercise sound business judgment, and elicit support, and influence cross departmentally. Presents a positive image of Joerns Healthcare through adherence to account protocol and presentation of professional behavior Ability to work after hours, overtime and weekends as required Must have valid driver's license. Preferred Skills, Experience & Education At least 7 years in allocation, distribution, inventory and logistics experience Proficiency in Excel, Word, PowerPoint, Outlook and Windows OS and ability to learn proprietary software systems. Ten (10) years' experience in the Inventory/Logistics field Experience with multi-location management Service experience in medical equipment rental markets Joerns Healthcare LLC is an Equal Opportunity Employer, including Disability/Veterans About Joerns Joerns Healthcare is a leading manufacturer of healthcare bed systems, patient lifting and repositioning solutions, therapeutic support surfaces, and complementary services. We enable the care and comfort of chronically ill patients in both institutional and home care settings. We continually strive to provide exceptional product and service solutions that deliver positive clinical, operational, and financial outcomes for our customers. We are currently seeking skilled, motivated, and dedicated professionals to join our team. We offer hands-on training, a comprehensive benefits package, and a rewarding work environment. Benefits At Joerns Healthcare LLC, each eligible employee receives a competitive total compensation package including Medical, Dental, Vision, Life Insurance and Short Term Disability. In addition, the company offers a 401K program with a company match, and Flexible Spending Accounts. Our employees also receive Paid Vacation and Holidays. Min USD $140,000.00/Yr. Max USD $160,000.00/Yr.

The Director of Field Operations is responsible for the execution of the field operations team, primarily located in the mid to southern CA and Portland, OR. The Director will be tasked with identifying goals, enabling tactics, and tracking metrics that lead to the optimization of achieved profitability, safety/compliance, customer satisfaction and associate acquisition, growth and retention. This individual must possess a strong leadership presence, with an operational acumen and analytical approach. Major Duties & Responsibilities Essential Functions * Execution of tactical plans in line with the Corporate Vision that achieve the growth objectives of the business, Ability to thrive in a fast-moving environment (Pace setter for rapid development and growth) * Key contributor to all field operations decision-making processes * Direct the day-to-day operations of a geographically remote and broad-based team * Participate in the implementation of business strategies to effectively achieve service fulfillment, inventory and financial objectives. * Refine and develop the Logistics, Inventory and Field Service capability, infrastructure, policies, procedures, and processes and ensuring they are maintained and adhered to in accordance with Company and regulatory & quality systems, policies, and guidelines. * Reconcile financial and operational results to ensure all information is correct. Take corrective action, as necessary. Provide management information reports. * Act in a collaborative capacity with all departments. Establish priorities and make workflow decisions. Assure that our contractual commitments are met. * Lead warehouse flow/set-up/RFI and other initiatives * Analyze business patterns to ensure optimal location and type of resources (staffing, facilities, inventory, vehicles, etc.) to meet shifting customer demand. * Perform and ensure quality completion of People Management strategy and systems. * Understand, manage, and direct the effective implementation of new equipment and technologies. Ensure effective utilization of existing equipment and systems. * Routine travel and visits to Equip Tech Centers, along with frequent customer communication and visits to assess customer satisfaction and staff competency. * Perform assigned stretch assignments to develop professionally. Supervisory Responsibilities: * Lead Service Fulfillment function, including staffing, processes and procedures. * Working in team environment with the Joerns executive members, Company's Business Units and third parties, to implement the go-to-market strategies for services and rental products. * Develop annual operating budgets for Logistics, Inventory and Field Service groups * Contribute to the develop cost optimized strategies, which meet customer and, quality requirements which both maintain existing business and support growth activities. * Contribute to the develop and execute strategies to meet financial goals and objectives. * Develop, implement, review, and adjust a robust management process for Logistics, Inventory and Field Service to ensure successful attainment of Joerns Service Group relevant goals and objectives * Direct and Monitor core Logistics, Inventory and Field Service performance, including delivery against service level agreements and cost objectives. * Skilled in management development, employee development and talent identification to create an associate resource to fuel growth. * Set and execute on a clearly stated vision, direction & goals for the function as well as to lead people for delivery of team/individual performance goals * Establish and use metrics that tie to Joerns Service Group priorities to drive behavior change and achieve goals. * Implement and maintain appropriate systems for measuring necessary aspects of operational management and development. * Monitor, and act on operational issues, opportunities and development plans and achievements within agreed formats and timescales * Direct and develop direct reporting staff * Manage and control departmental expenditure within agreed budgets * Develop active Customer Fulfillment and Logistics processes and systems which efficiently dispatch and execute activities ensuring Service Delivery performance goals are achieved and maintained. * Liaise with other functional/departmental managers to understand all necessary aspects and needs of operational and management development, and to ensure they are fully informed of objectives, purposes and achievements * Maintain awareness and knowledge of contemporary operational and management development theory and methods and provide suitable interpretation to directors, managers, and staff within the organization * Contribute to the evaluation and development of operational and management strategy and performance in cooperation with the management and executive teams * Ensure activities meet organizational requirements for quality management, health and safety, legal stipulations, environmental policies, and general duty of care. * Perform in a lawful and ethical manner, as referenced in the corporate ethics policy * Evaluate and upgrade the Company's Service Logistics, Inventory and Field Service (LIFS) function, which includes the people, operational and financial processes, technical systems, and internal and external relations. * LIFS Strategy - Develop the right Logistics, Inventory and Field Service strategy that supports and meets Services Logistics Group's performance objectives, and customer expectations. * LIFS Technology - Evaluate, determine, and deploy the required technology strategy for optimal Services performance and metrics Required Education 4-year degree in Management or relevant business background Required Skills & Experience * At least 5 years operations management experience * Must have excellent leadership, communication, and management skills, in a fast-paced high growth environment with expertise in allocation, distribution, inventory and logistics. * Ability to organize, lead, motivate, and care for all personnel and customer issues. * Must have experience managing and/or leading multisite field/logistic operations with a strong background in budgets and cost management. * Ability to travel and manage seamlessly from a remote site; Travel requirement 65-75% * Ability to manage customer expectations, lead direct reports and be flexible with both while meeting objectives. * Ability to work independently, exercise sound business judgment, and elicit support, and influence cross departmentally. * Presents a positive image of Joerns Healthcare through adherence to account protocol and presentation of professional behavior * Ability to work after hours, overtime and weekends as required * Must have valid driver's license. Preferred Skills, Experience & Education * At least 7 years in allocation, distribution, inventory and logistics experience * Proficiency in Excel, Word, PowerPoint, Outlook and Windows OS and ability to learn proprietary software systems. * Ten (10) years' experience in the Inventory/Logistics field * Experience with multi-location management * Service experience in medical equipment rental markets Joerns Healthcare LLC is an Equal Opportunity Employer, including Disability/Veterans About Joerns Joerns Healthcare is a leading manufacturer of healthcare bed systems, patient lifting and repositioning solutions, therapeutic support surfaces, and complementary services. We enable the care and comfort of chronically ill patients in both institutional and home care settings. We continually strive to provide exceptional product and service solutions that deliver positive clinical, operational, and financial outcomes for our customers. We are currently seeking skilled, motivated, and dedicated professionals to join our team. We offer hands-on training, a comprehensive benefits package, and a rewarding work environment. Benefits At Joerns Healthcare LLC, each eligible employee receives a competitive total compensation package including Medical, Dental, Vision, Life Insurance and Short Term Disability. In addition, the company offers a 401K program with a company match, and Flexible Spending Accounts. Our employees also receive Paid Vacation and Holidays. Min USD $140,000.00/Yr. Max USD $160,000.00/Yr.