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Vice President, Clinical Development - Durham, United States - Taysha Gene Therapies
Description
Company OverviewTaysha 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:
Vice President, Clinical Development
Reports to:
Chief Medical Officer
Location:
Dallas, TX; Durham, NC; Remote
Overview of Position
Reporting to the Chief Medical Officer (CMO), t he Vice President, Clinical Development will apply high level strategic planning as well as hands-on responsibilities to support clinical development activities across the Taysha pipeline.
.
This role will manage and lead a clinical development team for the Taysha portfolio, including programs at various stages in the development pipeline.
This role will serve as the primary clinical lead for one or more clinical trials from protocol development through study execution to completion of study reports, working closely with cross-functional areas towards product registration.
The Vice President, Clinical Development will own the risk benefit assessment for the program(s), and is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements, and market access.
Essential Duties & ResponsibilitiesProvide dynamic leadership, strategic direction and governance of the clinical development team and clinical activities across Taysha's portfolio.
Hire, develop and manage clinical development resources in accordance with program budget and timelines.
Partner with relevant functional leaders and team members to develop and execute the clinical strategy for assets across Taysha's portfolio.
Developand own
the Clinical Development Plan sections of an endorsed Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval and market access for one or multiple indications.
Lead the creation of clinical components of key documents (e.g., Clinical Trial Protocols,Investigator's Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with IDP and TPP.
Contribute to the development and review of clinical, regulatory, and scientific documents including manuscripts/journal articles, case report forms, statistical analysis plans, integrated summaries of safety (ISS), New Drug or Biologic License Applications (NDA/BLA), and/or other documents as needed, ensuring clinical content is harmonized.
Partner with Clinical Operations to provide oversight of trial execution to reach clinical milestones on time.Partner with Medical Safety Monitor to ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post- marketing surveillance.
Serve as a core member of the Safety Management Team (SMT).Provide proactive and ongoing assessment of pre-clinical, clinical, scientific literature, and other data to inform clinical strategy and ensure positive benefit-risk profile for assigned programs in collaboration with key stakeholders.
Minimum QualificationsMust thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to identify issues and raise to key stakeholders to develop relevant and realistic plans, programs, and recommendations.
MD or equivalent is preferred, but PhD, PharmD, or DVM with extensive clinical development experience and a documented track record of achievements will be considered.
Advanced clinical training/knowledge or clinical research experience in a medical/scientificarea, preferably aligned with Taysha's focused therapeutic areas (Epilepsy, PediatricNeurology, CNS).
Minimum 5 years of clinical development experience in an industry environment spanning clinical activities in Phases I through III/IV, including IND and NDA submission dossiers.
Considerable knowledge of ICH-GCP, clinical trial design, statistics, and regulatory/clinical development process.Experience with regulatory submissions and health authorities.
Demonstrated ability to establish strong scientific partnerships with internal and external key stakeholders.
Demonstrated leadership and strong communication skills with a documented track recordof delivering high quality projects/submissions/trials in a global/matrix environment in pharmaceutical or biotech industry or academia or clinical CRO.
Good culture fit with Taysha'sCore Values:
Integrity
Accountability
Teamwork
The level of this position will be based on the final candidate's qualifications.
Please 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.
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 ethnicorigin, 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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