Medical Director, Clinical Development
Remote
Full Time
Experienced
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: Medical Director, Clinical Development
Reports to: VP, Clinical Development
Overview of Position
Reporting to the Vice President, Clinical Development, the Medical Director, Clinical Development will have hands-on responsibilities to support clinical development activities across the Taysha pipeline with a focus on lead clinical program TSHA-102, an AAV gene therapy designed to treat Rett Syndrome. This role will serve as a key clinician on the clinical development team for one or more clinical trials from protocol development through study execution to completion of study reports, working closely with cross-functional areas toward product registration.
Essential Duties
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills with the ability to develop important relationships with key stakeholders, quickly identify issues and develop realistic plans, programs, and recommendations.
Base compensation range at time of posting: $200,000 – 300,000
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.
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: Medical Director, Clinical Development
Reports to: VP, Clinical Development
Overview of Position
Reporting to the Vice President, Clinical Development, the Medical Director, Clinical Development will have hands-on responsibilities to support clinical development activities across the Taysha pipeline with a focus on lead clinical program TSHA-102, an AAV gene therapy designed to treat Rett Syndrome. This role will serve as a key clinician on the clinical development team for one or more clinical trials from protocol development through study execution to completion of study reports, working closely with cross-functional areas toward product registration.
Essential Duties
- Serve as a key clinical development team member in cross-functional forums and program team meetings.
- Support development activities across the spectrum of drug development and execute against the clinical strategy, including interpretation of early-mid stage clinical data and designing late-stage and registrational clinical trials.
- Support building Clinical Development Plan (CDP) in line with critical program milestones and cross-functional plans, including collaborating with Regulatory, Operations, Safey, Medical Affairs and Commercial teams.
- Serve as a lead on the creation of clinical components for key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports (CSRs), relevant regulatory documents and interactions) with high quality and consistency with the CDP.
- Partner with Clinical Operations to provide oversight of trial execution to reach clinical milestones.
- Work closely with the Translational and Research teams to support initiation, execution, and interpretation of data from translational studies, as needed.
- As a medical expert on the clinical development team, participate in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy).
- Develop and present CRO/CRA/site training materials and present at Investigator Meetings/site initiation visits as required.
- Support the VP, Clinical Development with strategic planning and execution of a development program under the guidance of the Chief Medical Officer (CMO).
- Collaborate with the team to author/review abstracts, posters, and manuscripts for publication.
- Partner with the VP Clinical Development, CMO, VP Safety and 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.
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills with the ability to develop important relationships with key stakeholders, quickly identify issues and develop realistic plans, programs, and recommendations.
- MD, DO, or equivalent required, with extensive clinical development experience and a documented track record of achievements.
- Advanced clinical training/knowledge or clinical research experience in a medical/scientific area, preferably aligned with Taysha’s focused therapeutic areas (Rare Disease, Pediatric Neurology, Neurodevelopment, Neurogenetics).
- 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 – multiple jurisdictions preferred.
- Demonstrated ability to establish strong scientific partnerships with internal and external key stakeholders.
- Demonstrated leadership and strong communication skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment in pharmaceutical or biotech industry or academia or clinical CRO.
- Natural fit and role model for Taysha Values of Integrity, Accountability and Teamwork.
Base compensation range at time of posting: $200,000 – 300,000
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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