• Provides strategic clinical oversight and support of the day-to-day clinical community operations to Executive Directors, Health and Wellness Directors and clinical associates, as well as district and regional team leaders above assigned communities. • Supports the company goals and strategies and optimizes resources to ensure quality care and service delivery, training and development of staff, and management of risk and regulatory compliance. • Responsible for the successful implementation and maintenance of community support center clinical policies and procedures. • Conducts regular clinical quality audits through community site visits and audits of all health care areas to ensure compliance with Brookdale standards and state regulations, appropriate resident assessments, appropriate staffing, staff training, and quality assurance. Provides a written report of findings and ensures action planning is in place for areas of risk. • Analyzes specific community models to support staffing of clinical positions based on community size and residents receiving services. • Supports the implementation of quality care and services, and encourages the development of medical professional relationships within the community. Encourages alignment with value-based provider groups focused care delivery outcomes. • Oversight of community survey readiness for regulatory compliance. • Monitors compliance and assists communities in root cause and corrective action of community quality metrics and clinical outcomes related to falls, elopements, medication administration and reduction of psychotropic drugs as well as skin integrity. Supports community infection control measures and risk in partnership with Executive Director. • Analyzes resident incident reports and supports the community in corrective action plans as appropriate. • Verifies that a Community Care Conference and Collaborative Care Process is in place in accordance with policy, and makes plans to attend virtually or in person as needed. • Reviews resident clinical assessments to validate accuracy of resident’s physical, emotional and mental functioning, and validates that clinical services provided to residents are documented in appropriate system/record. • Ensures the CARE process is being executed appropriately to address controllable resident move outs. • Provides clinical guidance to field staff, when necessary, to determine appropriate level of care for resident move-ins. • Supports the community’s overall resident/family satisfaction level as related to clinical care and impact to the overall community. • Promotes the community preferred pharmacy relationship and supports 80% or greater resident participation. Supports any innovative projects or implementations that drive resident wellbeing or satisfaction. • Supports the community-based Personal Solutions program, ensures a community leader is identified, endorses resident participation and actively assists community with managing the affiliated budgeted goal. • Participates in hiring, training, and mentoring of Health and Wellness Directors and other field level clinical associates. Actively supports onboarding of these associates, coaching and providing them an exceptional experience in the first ninety days. • Analyzes resident and medication incident reports and assesses trends and assists with process improvement plans. Reviews various healthcare reports, trends, and move-outs to assist in process improvement efforts.

• Compliance: Act as the primary physician of record for Georgia-based aesthetic practices, ensuring all delegation follows the specific Georgia Composite Medical Board rules. • Protocol Approval: Approve and oversee clinical protocols for treatments including botulinum toxin, dermal fillers, IV therapy, and laser services. • Multi-Site Oversight: Supervise and delegate medical procedures to qualified staff (RNs, NPs, aestheticians) across multiple locations in compliance with state laws. • Operational Partnership: Support the Ops team by providing timely signatures and mandatory training certifications to get member supplier accounts active. • Chart Auditing: Log into the EMR to review a randomized 10% of patient charts monthly to ensure documentation standards are met. • Adverse Event (AE) Management: Leverage Fresh’s centralized clinical team as the primary resource for complication management, and provide clinical support or guidance when needed, rather than acting as the sole complication manager. • Clinical Community: Attend ongoing webinars and the monthly USA Doctors’ “Morbidity and Most-Excellent-cases” meeting.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. - Lead and execute the clinical development strategy for gene therapy programs across early- and late-stage development (Phase 1–3) - Provide medical and scientific input into clinical trial design, protocol development, dose escalation strategies, and endpoint selection, particularly for CNS and movement disorders - Oversee all clinical trials from initiation through completion, ensuring data integrity, patient safety, and regulatory compliance - Collaborate with internal cross-functional teams and external partners, including CROs, investigators, vendors, and regulatory agencies - Conduct clinical risk assessments and implement appropriate mitigation strategies, including safety monitoring and benefit–risk evaluations - Contribute to regulatory interactions, including briefing documents, investigator brochures, and responses to health authority questions - Present clinical data and development updates to senior management, governance committees, and external stakeholders - Supervise, mentor, and support clinical team members and contribute to a high-performing development organization - Establish and maintain oversight of clinical monitoring activities across studies in a highly regulated environment, ensuring compliance with ICH-GCP, regulatory requirements, and internal quality standards - Author and review key clinical and regulatory documents, including clinical protocols, investigator brochures, clinical study reports, and regulatory submissions, ensuring scientific rigor, clarity, and compliance with applicable regulatory requirements and internal standards - Drive innovation in clinical trial execution, particularly in rare disease, CNS, and gene therapy settings Qualifications - MD from an accredited U.S. medical school or equivalent international medical degree with 6+ years’ relevant work experience - Completion of clinical training with demonstrated clinical experience; board certification or eligibility in Neurology or a closely related specialty - Minimum of 3 years of industry experience or related experience in clinical research or clinical development within the pharmaceutical, biotechnology, medical device, CRO/CDMO, or closely related academic or translational research setting - Direct experience contributing to the design and execution of clinical trials, including protocol development and clinical data review - Demonstrated working knowledge of Good Clinical Practice (GCP), including clinical monitoring, safety oversight, and data quality standards - Experience supporting inspection readiness activities, including preparation for or participation in FDA or other health authority inspections, audits, or internal quality reviews - Ability to independently perform the core duties of a Medical Director in a regulated drug development environment - Ability to provide medical oversight for FDA inspection readiness, including review of key trial documentation, monitoring outputs, and safety narratives - Experience reviewing and interpreting monitoring reports, audit findings, protocol deviations, and CAPAs - Strategic oversight of risk-based monitoring and trial quality management approaches - Understanding of gene therapy–specific safety risks, including delayed adverse events and durability considerations requiring extended follow-up - Strong analytical and problem-solving skills applied to clinical, safety, and compliance issues - Excellent written and verbal communication skills, including interaction with senior leadership and regulatory agencies Preferred Education, Experience and Skills - Prior experience in CNS, neurology, or movement disorders clinical development - Experience with gene therapy, cell therapy, or other advanced therapeutic modalities - Experience supporting or leading early Phase development programs including Phase 1 and 2 and/or Phase 3 trials, including registrational strategies - Experience with long-term follow-up (LTFU) studies, including post-treatment safety monitoring required for gene therapy products - Direct experience partnering with CROs and CRAs on monitoring strategy, risk-based monitoring, and vendor oversight - Experience working in rare disease or small patient population studies

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We’re looking for a Senior Director, Medical Affairs - Respiratory to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Global Medical Strategy & Communications, the Senior Director will develop, implement, and lead therapy strategy and planning for Medical Affairs across all geographic regions ensuring a cohesive approach. - Develop and lead medical affairs activities ensuring partnership within the team (medical strategy, scientific communications and publications). - Maintain high-level cross-functional collaboration across the organization to ensure alignment and One Insmed approach. - Drive the development and execution of Medical Affairs plans ensuring strategy is reflected in medical plans. - Provide medical leadership input for cross-functional partners including clinical, operations, HEOR, and commercial. - Build an external relationship network across therapy area (respiratory) to support the franchise and gain advice. - Develop data generation strategy including gap analysis to evolve product data generation plans. - Review publications, help create medical backgrounders, FAQs, and standard responses, and develop internal training approach. - Develop full thought leader engagement strategic approach and ensuing plan. - Partner with Medical Strategy, Regions, and Finance to plan and manage annual budget for medical activities. - Ensure a comprehensive and synergistic approach by collaborating across Medical Affairs, Regions, and other functions. - Partner with stakeholders to identify and integrate innovative ideas and best practices into strategies, plans, and activities. Qualifications - MD with previous experience in pulmonology. - Leadership experience across Medical Affairs. - 8+ years of overall pharmaceutical or biotech experience. - Strong knowledge of Medical Affairs and a robust understanding of medical affairs planning with previous launch experience. - Demonstrated ability to develop innovative approaches within Medical Affairs. - Ability to work independently and thrive as the Medical Affairs representation within cross-functional teams. - Previous leadership experience in medical affairs and ability to lead by influence within a matrixed team. - Proven track record of leading process and operational excellence and developing planning standards. - Ability to collaborate with multiple stakeholders and functions. - Strong attention to detail; strategic thinker with ability to connect multiple components. - Proven history of effectively driving change. - Strong communication skills (written and verbal). - Passion for and demonstrated experience in enabling creative problem solving and encouraging unique solutions. Requirements - Board Certified Pulmonologist is strongly preferred. - Global experience or experience in multiple regions including the US is an advantage. Benefits - Comprehensive medical, dental, and vision coverage and mental health support. - Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP). - Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules. - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP). - Company-paid life and disability insurance. - Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities. - Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back. Travel Requirements - This position involves frequent domestic and international travel (up to 25%).