Taysha Gene Therapies
VP/SVP, Clinical Operations
Taysha Gene Therapies, Dallas, Texas, United States, 75215
Company Overview
Taysha Gene Therapies is a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations.
Position Title:
VP/SVP, Clinical Operations Reports to:
Chief Medical Officer Location:
Remote
Overview of Position The Senior Vice President, Clinical Operations will lead all clinical trial activities globally, ensuring high standards of execution and compliance with local and global regulatory requirements. This role involves managing relationships with vendors, CROs, PIs, and other key stakeholders, acting as the primary liaison between external stakeholders and internal cross-functional teams. The position requires a strong blend of leadership, operational expertise, vendor management, and cross-functional collaboration.
Essential Duties Ensure that resources, personnel, and expertise are appropriately prioritized and deployed to meet study timelines and budgets successfully and efficiently. Present clinical operation strategy and program status updates to executive leadership weekly and JIT when required. Lead all aspects of study progress from planning to close-out in accordance with ICH-GCP guidelines, local regulations, patient safety standards and compliance with internal Standard Operating Procedures (SOPs). Establish key performance indicators (KPIs) and oversee vendor performance metrics, managing any issues or escalations as needed. Provide support and oversight to staff for development and optimization of global clinical strategy and processes, including effective delegation to direct reports to meet program goals. Proactively work with cross-functional teams to develop and implement study plans. Facilitate problem-solving and conflict resolution with internal and external stakeholders to reduce issues/remove roadblocks and keep teams on track with key deliverables. Accountable for ensuring accurate and up-to-date study and program information within relevant tracking systems and providing regular updates; proactively identify, risk-manage, and resolve issues that arise during study and program conduct; manage escalation of study and program-related issues. Oversee the development of budgets and timelines for program(s). Work with study team(s) to ensure accurate forecasting, tracking, and timely review of study budgets. Facilitate timely escalation of variances within established processes. Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO, and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Work very closely with study investigators to ensure timely and high-quality execution of clinical studies. Lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, inspection readiness plans, and CSRs. Translate corporate and department goals into relevant, tangible, and measurable objectives for the operations team. Hire, coach, and manage a high performing clinical operations team. Drive and manage their individual and collective performance. Serve as a role model to Clinical Operations and cross-functional teams, in problem identification, cross-functional collaboration, and implementation of planned resolutions. Skill & Education Requirements Bachelor’s degree with 15+ years’ progressive clinical operations experience with minimum 5+ years leading the clinical operations function. Demonstrated knowledge of operational aspects of managing phase I-III international clinical studies from initiation to BLA. Demonstrated excellence in complex project management and effective management of multiple projects/priorities. Comfort with presenting and interacting at the executive and Board levels. Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Must be flexible and able to change direction quickly. Excellent written and verbal communication skills. Experience with regulatory filings (e.g., NDA, BLA, MAA). Previous involvement in the oversight and management of GCP regulatory inspections. Excellent knowledge of ICH-GCP. Ability to travel approximately 20%, as needed (domestic and international). Ability to communicate at the highest level in a cross-functional executive setting. Experience with rare disease required. Knowledge of AAV gene therapy a plus. Natural fit with Taysha values of Integrity, Accountability, and Teamwork. Compensation and Benefits Base compensation range at time of posting: $300 – 400,000. The actual base salary depends, in part, on the successful candidate’s qualifications for the role, including education and experience. Taysha offers a comprehensive compensation and benefits program to eligible employees, including Individual Stock Option awards; ESPP program; eligibility to participate in performance bonus program; company-sponsored 401(k) with matching contribution; eligibility for medical, dental, vision, and prescription drug benefits and a generous vacation/holiday schedule. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Taysha is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Taysha are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
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Position Title:
VP/SVP, Clinical Operations Reports to:
Chief Medical Officer Location:
Remote
Overview of Position The Senior Vice President, Clinical Operations will lead all clinical trial activities globally, ensuring high standards of execution and compliance with local and global regulatory requirements. This role involves managing relationships with vendors, CROs, PIs, and other key stakeholders, acting as the primary liaison between external stakeholders and internal cross-functional teams. The position requires a strong blend of leadership, operational expertise, vendor management, and cross-functional collaboration.
Essential Duties Ensure that resources, personnel, and expertise are appropriately prioritized and deployed to meet study timelines and budgets successfully and efficiently. Present clinical operation strategy and program status updates to executive leadership weekly and JIT when required. Lead all aspects of study progress from planning to close-out in accordance with ICH-GCP guidelines, local regulations, patient safety standards and compliance with internal Standard Operating Procedures (SOPs). Establish key performance indicators (KPIs) and oversee vendor performance metrics, managing any issues or escalations as needed. Provide support and oversight to staff for development and optimization of global clinical strategy and processes, including effective delegation to direct reports to meet program goals. Proactively work with cross-functional teams to develop and implement study plans. Facilitate problem-solving and conflict resolution with internal and external stakeholders to reduce issues/remove roadblocks and keep teams on track with key deliverables. Accountable for ensuring accurate and up-to-date study and program information within relevant tracking systems and providing regular updates; proactively identify, risk-manage, and resolve issues that arise during study and program conduct; manage escalation of study and program-related issues. Oversee the development of budgets and timelines for program(s). Work with study team(s) to ensure accurate forecasting, tracking, and timely review of study budgets. Facilitate timely escalation of variances within established processes. Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO, and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Work very closely with study investigators to ensure timely and high-quality execution of clinical studies. Lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, inspection readiness plans, and CSRs. Translate corporate and department goals into relevant, tangible, and measurable objectives for the operations team. Hire, coach, and manage a high performing clinical operations team. Drive and manage their individual and collective performance. Serve as a role model to Clinical Operations and cross-functional teams, in problem identification, cross-functional collaboration, and implementation of planned resolutions. Skill & Education Requirements Bachelor’s degree with 15+ years’ progressive clinical operations experience with minimum 5+ years leading the clinical operations function. Demonstrated knowledge of operational aspects of managing phase I-III international clinical studies from initiation to BLA. Demonstrated excellence in complex project management and effective management of multiple projects/priorities. Comfort with presenting and interacting at the executive and Board levels. Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Must be flexible and able to change direction quickly. Excellent written and verbal communication skills. Experience with regulatory filings (e.g., NDA, BLA, MAA). Previous involvement in the oversight and management of GCP regulatory inspections. Excellent knowledge of ICH-GCP. Ability to travel approximately 20%, as needed (domestic and international). Ability to communicate at the highest level in a cross-functional executive setting. Experience with rare disease required. Knowledge of AAV gene therapy a plus. Natural fit with Taysha values of Integrity, Accountability, and Teamwork. Compensation and Benefits Base compensation range at time of posting: $300 – 400,000. The actual base salary depends, in part, on the successful candidate’s qualifications for the role, including education and experience. Taysha offers a comprehensive compensation and benefits program to eligible employees, including Individual Stock Option awards; ESPP program; eligibility to participate in performance bonus program; company-sponsored 401(k) with matching contribution; eligibility for medical, dental, vision, and prescription drug benefits and a generous vacation/holiday schedule. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Taysha is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Taysha are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
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