[Hiring] Senior Medical Director, Pharmacovigilance and Safety @Taysha Gene Therapies

Role Description

The Senior Medical Director, Pharmacovigilance and Safety, will provide clinical/scientific/pharmacovigilance expertise to lead signal detection, benefit-risk evaluation, and risk management activities in support of Taysha’s products throughout their lifecycle. This includes the development of processes to support the proactive identification, evaluation, and management of safety risks for assigned Taysha products. In addition, she/he will function in a cross-functional and collaborative environment partnering with various departments.

Essential Duties

• Lead safety assessments, signal detection, and risk management activities for assigned products.
• Perform individual case safety report (ICSR) medical review to ensure accurate medical coding, seriousness, expectedness, and company causality assessment.
• Collaborate with cross-functional teams to design, evaluate, implement, and oversee safety risk mitigation strategies.
• Address internal/external safety-related information requests.
• Author and/or review pre- and post-marketing aggregate safety reports.
• Lead and/or contribute to the development and maintenance of Reference Safety Information (RSI).
• Support the development of standard operating procedures (SOPs) and/or other process-related documents.
• Active participant in inspection readiness activities, internal audits, and external inspections.
• Maintain knowledge of new PV/safety regulations and guidance from regulatory authorities.
• Maintain knowledge of disease indications for assigned investigational and/or marketed products.

Qualifications

• MD, DO, or equivalent required; additional postgraduate training in neurology, pediatrics, and/or rare disease preferred.
• 10+ years of pharmacovigilance experience within the biopharmaceutical industry.
• Experience as safety lead for development asset.
• Oversight experience of global medical safety activities.
• Demonstrated knowledge of global PV regulatory environment.
• Working knowledge of industry standard safety databases and coding activities.
• Excellent knowledge of drug development process.
• Experience reviewing cumulative safety data and developing risk management strategies.
• Ability to navigate fast-paced and dynamic work environment.
• Demonstrate leadership and interact collaboratively in a team environment.
• Excellent organizational and communication skills.
• International/domestic travel may be required.
• Natural fit with Taysha’s Values of Integrity, Accountability and Teamwork.

Requirements

• This is a remotely based position in the U.S.

Benefits

• Expected base compensation range: $325,000 – 375,000 target annual salary, depending on experience and qualifications.
• Comprehensive compensation and benefits program 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.
• A generous vacation/holiday schedule.