Vice President, Drug Safety and Pharmacovigilance (EDG-2025065)

Vice President, Drug Safety and Pharmacovigilance (EDG-2025065)

About Edgewise Therapeutics:

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position:

The Vice President, Drug Safety and Pharmacovigilance will lead the development and execution of the company's safety strategy across all stages of product development and commercialization. This executive role requires a dynamic leader capable of overseeing pharmacovigilance operations, safety surveillance and risk management, ensuring regulatory compliance, and providing safety leadership across clinical development programs and post-marketing.

Essential Job Duties and Functions:

• Strategic Leadership: Develop and execute a comprehensive drug safety and pharmacovigilance strategy aligned with the company's objectives and regulatory requirements.
• Safety Surveillance: Oversee safety signal detection, evaluation, and risk mitigation strategies for all products in the clinical and commercial pipeline.
• Regulatory Compliance: Ensure compliance with global safety regulations, including those from the FDA, EMA, and ICH guidelines.
• Team Building: Build and lead a high-performing pharmacovigilance and drug safety team, fostering a collaborative and high-performance culture.
• Cross-Functional Collaboration: Work closely with Clinical Development, Regulatory Affairs, and Medical Affairs to embed patient safety throughout the product lifecycle.
• Risk Management: Oversee the development, implementation, and maintain risk management plans, safety monitoring plans, and safety data exchange agreements for clinical programs and marketed products.
• Medical Oversight: Provide medical oversight for safety activities, including the review and assessment of individual case safety reports and aggregate safety data.
• Regulatory Interactions: Serve as the primary point of contact for pharmacovigilance interactions with regulatory authorities and external partners. Provide strategic oversight for safety sections of regulatory filings, including INDs, BLAs, NDAs, and MAA.
• Transition processes and create new infrastructure into a post marketing landscape, when applicable.
• Work with senior leaders to establish and/or optimize a strategy for organizational build, process improvement initiatives and operational efficiency as our product portfolio grows.
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.

Required Education, Experience and Skills:

• Education: MD/PharmD or equivalent with relevant clinical experience.
• Experience: Minimum of 10 years in pharmacovigilance and drug safety roles within the biotech or pharmaceutical industry, with at least 5 years in a leadership position.
• Therapeutic Area Expertise: Experience in gene editing or rare diseases is highly desirable.
• Regulatory Knowledge: Strong understanding of global safety regulations and industry standards.
• Proven experience: with successful BLA and MAA regulatory submission and interactions that have led to approvals and product launch.
• Leadership Skills: Proven track record of building, managing, developing, and motivating high-performing teams and leading in a matrixed environment.
• Communication Skills: Excellent verbal and written communication skills, with the ability to present complex information to diverse audiences.

Salary range: $325,000 - $400,000, title and salary commensurate with experience.

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.