Senior/Executive Medical Director, Pharmacovigilance (Information Technology)

Job Description:

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California,

Position Summary

This position is responsible for providing oversight and management of all activities pertaining to product safety and pharmacovigilance in clinical development and post-marketing surveillance. The Senior Medical Director/ Executive Medical Director, Pharmacovigilance ensures that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and

communication of safety information for CRISPR Therapeutics products, are globally completed. This includes oversight of all safety activities, including those performed by external suppliers, for CRISPR Therapeutics.  The successful candidate will translate a safety mindset into the organization more broadly and will tailor safety solutions to the specific needs of the company.

Responsibilities

• Establish and maintain safety governance oversight for all CRISPR Therapeutics products
• Provide hands-on leadership and expertise for the company in all PV matters and drive a safety mindset across teams
• Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including clinical study protocols, development plans, INDs/CTAs/ BLAs and all other PV issues, as appropriate.
• Successfully plan and forecast for global resources and PV budget and partner with other groups on resource needs (e.g., medical writing for regulatory document writing, biometrics for biostatistical needs; clinical development for call center activities and epidemiology project needs)
• Interact with internal and external colleagues to develop PV related programs and processes to meet regulatory reporting requirements
• Manage PV Operations, providing strategic direction for our PV operations efforts
• Lead process improvement within global pharmacovigilance – including technology assessment and implementation
• Oversee PV consultant activities related to aggregate reporting, management of risk-benefit profiles, signal detection and risk management and mitigation plans for clinical and post-marketing compounds
• Ensure compliance of operations with governing regulatory requirements
• Lead and support audits with health authorities and development partners
• Implement global process standardization and improvement.

Minimum Qualifications

• MD degree or equivalent required
• 3+ years of clinical practice experience
• At least 6 years of direct pharmaceutical industry experience

Preferred Qualifications

• Experience in both biotech and pharmaceutical companies
• Cross-functional development experience and problem-solving orientation to find optimal compliant business solutions tailored to company needs
• Strength in relationship building and partnership focus in collaborating with colleagues across teams 

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy