• Provide clinical leadership and oversight of all owned PACE programs • Collaborate with a variety of system-level leaders in the departments of Finance, Quality, Compliance, Informatics, Coding, Claims adjudication, Education, Credentialing and Operations • Create and maintain an atmosphere of warmth, propagating a calm environment throughout the office • Promote and maintain collaborative relationships with managers, peers, direct reports and customers • Coordinate communication with Pharmacy Benefit Manager and pharmacy provider(s) as necessary • Participate in Part D audits and development of corrective action plans • Establish expectations for Utilization Management meetings

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Head of Drug Safety will serve as the strategic and operational leader for the company’s pharmacovigilance function. This role combines medical oversight and PV scientist responsibilities with strong team leadership, ensuring robust safety surveillance for marketed products and clinical programs. The ideal candidate is an MD with deep expertise in pharmacovigilance and drug safety, capable of managing both hands-on activities and team leadership in a small, fast-paced biotech environment. Key Responsibilities - Leadership - Lead and mentor a small team of PV professionals (scientist and operational roles). - Foster a culture of compliance, scientific rigor, and continuous improvement. - Reporting to the Chief Medical Officer, contribute as a key member of the MedCORE and Genetix Leadership Teams. - Medical Oversight - Serve as the Medical Director for all marketed and investigational products. - Perform medical review and assessment of adverse event reports, including seriousness, causality, and expectedness. - Author and approve aggregate safety reports (e.g., DSURs, PBRERs, SMP/RMP updates). - Provide medical input into signal detection, risk evaluation, and mitigation strategies. - Act as the primary medical contact for regulatory authorities on safety matters. - PV Operations & Compliance - Oversee case processing activities, including timely submission of ICSRs to regulatory authorities (FAERS, EudraVigilance). - Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA). - Lead signal detection and management processes, including periodic safety reviews and safety committees. - Maintain and update PV SOPs, policies, and governance frameworks. - Manage vendor relationships for PV services and ensure quality oversight. - Cross-Functional Leadership - Collaborate with Clinical Development, Regulatory Science, Quality, and Medical Affairs to ensure integrated safety strategies. - Provide PV input into clinical trial protocols, informed consent forms, and investigator brochures. - Support labeling updates and safety sections of regulatory submissions (IND, BLA, variations). Qualifications - MD degree required; clinical experience in a relevant specialty (e.g., hematology, oncology, cell and gene therapy) preferred. - 10+ years of pharmacovigilance experience, including leadership roles. - Proven experience with post-marketing PV and clinical trial safety; experience in hemoglobinopathies or cell and gene therapy preferred. - Strong knowledge of global PV regulations (FDA, EMA, ICH); experience with interaction with regulatory authorities on safety matters preferred. - Proficiency in using electronic safety databases (i.e., Argus). - Excellent analytical, communication, and decision-making skills. - Ability to thrive in a small biotech environment, balancing strategic and hands-on responsibilities. Requirements - Base Salary Range: $326,485 - $403,382. - This role is eligible for an annual bonus and long-term incentive. - Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law. Benefits - Comprehensive health, life and disability insurance. - Employer-matched 401(k) plan. - Lifestyle spending account. - Flexible time-off + paid holidays and winter shutdown. - Tuition reimbursement & loan repayment assistance. - Paid parental leave. - Generous commuter subsidy. - And much more. Company Description Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Provide integrated support to patients and physicians by providing a "hands-on" approach to improve the quality of patient care. This is accomplished by developing personalized relationships with patients and prescribers of assigned clinics to improve medication adherence and promote evidence-based care expanding into various disease states therapy management. - The Ambulatory Clinical Pharmacist (ACP) will help advance quality pharmacotherapy care by actively assuring the provision of safe, efficacious, and cost-effective drug therapy. - The ACP works remotely and collaborates closely with hybrid ACP team onsite to maximize full suite of therapy management (TM) clinical services within supported clinics. - The pharmacist performs phone, virtual or video-based assessments on disease state management and drug therapy education stratified based on medication risk level and approved clinic protocol. - ACP role will focus to identify, resolve, and prevent medication-related problems. - Additional services will also be offered to overcome identified barriers to medication compliance and any other obstacle related to adherence. SUMMARY: - Provide medication management for individuals, including medication reconciliation, dose optimization, and medication adherence counseling within the stated parameters of the approved protocol/CPA/CDTM. - Collaborate with the interdisciplinary care team to develop individualized care plans that align with evidence-based guidelines and best practices for therapy management. - Monitor and evaluate medication regimens to ensure clinical criteria are met, including therapeutic goals, adverse effects, and drug interactions. - Identify opportunities for drug therapy optimization and provide recommendations for medication cost savings initiatives when applicable. - Participate in quality improvement initiatives by actively participating in clinical outcome studies, REMs compliance/reporting, and ACP-related process improvement projects. - Optimize resources and workflows with supporting roles handling complex prior authorizations/appeals by providing clinical justification for medication approval, including supporting literature and rationale. - Collaborate with healthcare providers, including assigned clinic physicians, specialists, and onsite clinic pharmacists, to ensure seamless medication management and coordination of care. - Support occasional peer-to-peer requests upon demand. - Perform clinical assessments/educational counseling at drug-level for all patients within high priority clinics on qualified on a targeted medication(s). - Ensure all clinical criteria is in clinical compliance with guidance from FDA, clinical guidelines, and appropriate evidence-based literature. - Assist with workflow optimization initiatives, including identifying areas for improvement and implementing strategies to enhance efficiency, productivity, and quality of care. - Collaborate with other departments and stakeholders to identify operational changes and recommend strategies that enhance productivity, quality, and standards of excellence. - Advocate for and promote patient safety and medication literacy through patient education and counseling. - Protects organization's value by keeping information confidential. - Updates job knowledge by participating in educational opportunities; professional publications; maintaining personal networks; participating in professional organizations to promote new line of services. - Attend and participate in team meetings, conferences, and other professional development activities to stay abreast of current clinical practices and emerging trends. - Stay updated with the latest advancements in therapy management and incorporate them into clinical practice. - Willing to do whatever is necessary for the betterment of the Company. - Other duties as assigned by Senior Director of Clinical Services and Manager of Clinical Services. Qualifications - Applicant must hold a Doctor of Pharmacy (PharmD) and be a licensed pharmacist in CA. - Applicant must be an advanced practice pharmacist in CA, by meeting two of these three criteria listed below: - A. Possession of a current certification in relevant area of practice (certified by ACPE as outlined in the California Business & Professions Code): 4210(a)(2)(A). - B. Completed a postgraduate residency earned in the United States through an accredited postgraduate institution. - C. Provided 1,500 hours of clinical experience under a collaborative practice agreement or protocol to patients within 10 years of application, where clinical experience includes initiating, adjusting, modifying or discontinuing drug therapy of patients. - Completion of PGY1/PGY2 residency is preferred, but not required. - Required 3+ years' experience as a clinical pharmacist. Requirements - Ability to analyze information, exercise good judgment, possess strong verbal communication skills, have deep knowledge of pharmacology developments and FDA health regulations. - Ability to manage processes, exhibit strong technical and clinical skills, maintain constant focus on legal compliance, while being highly productive with a focus on quality and details. - Strong clinical knowledge and validated expertise with focus on disease state management and treatment guidelines. Traits - Organized, high-integrity, attention to detail, dependable, quality focus, empathetic, good listener/communicator. - Energetic, highly motivated, team player with strong personal and communication skills; discretion and confidentiality essential as position deals with highly sensitive and private data. Salary - An employee in this position who performs the job duties in California can expect a salary rate between $127,000 and $155,000 plus bonus pursuant to the terms of any bonus plan if applicable. The actual salary will depend on experience, geographic location, and other factors permitted by law. - An employee in this position who performs the job duties in any other state can expect a salary rate between $127,000 and $133,000 plus bonus pursuant to the terms of any bonus plan if applicable. The actual salary will depend on experience, geographic location, and other factors permitted by law.

• Lead and oversee all psychiatric teams providing telehealth care to older adults with SMI, SUD and dementia. • Design, refine, and scale a nationally consistent model of value-based geriatric psychiatry. • Drive quality improvement, compliance, and performance metrics. • Monitor and track key quality and outcome indicators, making necessary adjustments to the organization's plan. • Collaborate with product and technology teams to translate clinical workflows into the technology platform. • Lead clinical recruitment, onboarding, training and education programs. • Develop and implement online learning platform and supervision processes. • Drive and cultivate excellence in patient care across clinical teams. • Support primary care providers through training and consultation. • Build and maintain relationships with key stakeholders.