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: Associate Director, Regulatory Affairs Project Manager
Reports to: Director, Regulatory Affairs and Program Management Team Lead
Location: Dallas, TX; Durham, NC or Remote
Overview of Position
The Associate Director, Regulatory Affairs Project Management will be responsible for supporting the development and implementation of program strategy. The individual will be a key member of the organization and will partner with internal cross functional team leads to provide direction and program management toward regulatory milestones. The ideal candidate is one who is experienced in drug development, has a demonstrated track record of collaborating with cross-functional development teams across the product lifecycle, is an excellent communicator and understands development process interdependencies.
To be successful in this role, you must be able to create highly integrated program plans, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills.
Essential Duties-
Key responsibilities include collaborating with multi-functional teams, facilitating and documenting project team meetings, driving cross-functional planning, communication and decision making, and ensuring alignment with internal functional groups and program leadership.
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Develop, track, and maintain functionally integrated detailed project timelines and deliverables to enable accurate project analyses, identification of critical path activities, and areas of resource constraint.
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Manage risk mitigation strategies, assessment of project risks and support mitigation planning and tracking.
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Escalate critical issues and delays to program leadership with a plan-of-action to address.
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Manage the program team collaboration site and program information materials.
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Communicate effectively and build a positive working relationship with internal and external key stakeholders on assigned programs.
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Track progress against plans and communicate timely and accurate status updates both formally and informally.
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Manage and organize regulatory and cross functional team meetings.
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Develop, maintain, track, high-quality program timelines, and dashboards to enable accurate team reporting and decision making.
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Use project and regulatory knowledge and facilitation to enable effective team meetings.
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Contributes to the functional excellence of Regulatory project management in the development of continuous improvement of processes, procedures, and tools related to program and portfolio management practices.
Skill & Education Requirements-
Bachelor’s degree in life science or other relevant field required; advanced degree strongly preferred.
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Advanced understanding of program management and associated deliverables, tools, and expectations; PMP or similar certification highly preferred
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A minimum of 5 years drug development experience in the pharmaceutical industry including a minimum of 2 years project management or equivalent experience
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Strong understanding of the drug development process including strategic and operational aspects
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Strong knowledge of clinical, non-clinical, CMC and regulatory requirements
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Exceptional interpersonal, organizational, analytical, and problem-solving skills
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Excellent oral and written communication skills
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Proven ability to think strategically but work tactically throughout the project management lifecycle.
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Highly proficient in Word, Excel, PowerPoint, Microsoft Project, and SharePoint
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Experience in other project management tools or software applications a plus; experience with Smartsheet desired.
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Ability and passion to work in demanding, dynamic, fluid, and fast-paced environment.
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Clear understanding of the critical path and a drive to find solutions to meet or exceed timelines.
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Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines.
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Demonstrates sound judgment and leadership skills.
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Good culture fit with Taysha’s Values:
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Integrity
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Accountability
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Teamwork
Base compensation range at time of posting: $150,000 – 200,000
The actual base salary depends, in part, on the successful candidate’s qualifications for the role, including education and experience. Tysha 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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