What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

This newly created position of VP Pharmacovigilance will lead the safety and pharmacovigilance (PV) activities for Editas’ expanding clinical portfolio supported by our unique gene editing platform. The position represents a key partner in establishing and driving forward tactical plans to enable Editas to deliver on its mission to translate the power and potential of genome editing into a broad class of in-vivo and cellular treatments that transform lives of people living with serious diseases.

The qualified candidate will lead PV team responsible for safety of clinical studies of all therapeutic area in the pipeline, participate clinical development plan, clinical study design and execution and regulatory submission. The PV team will lead safety data analyses, the identification and investigation of potential safety signals, development of risk management and pharmacovigilance plans, safety related regulatory reporting to ensure compliance and timely reporting of adverse events in accordance with the regulatory requirements of the applicable Regulatory Agencies.

The individual will report to the Chief Medical Officer and will operate in a matrixed role interfacing closely with Clinical Development, Biometrics, Clinical Operations, and Regulatory, with support from external CROs.

The successful candidate will:

• Be the leader of pharmacovigilance for Editas’ clinical programs in partnership with Clinical Development, Biometrics, Clinical Operations and Regulatory Functions.
• Lead the safety and risk management of the clinical studies; monitor and analyze the safety data
• Lead the development of risk management plans and associated documents to ensure that study-specific and health authority reporting requirements are met and that workflow between contract research organizations (CROs) and Editas is delineated
• Ensures timely submission of expedited safety reports to Regulatory Authorities in conjunction with Regulatory Affairs and/or Contract Service Provider
• Oversee and manage PV vendor(s) to ensure regulatory compliance and contractual obligations are met
• Reviews the safety sections of clinical documents, including protocols, annual reports, investigational brochures, and other documents
• Oversees SAE database reconciliation in collaboration with Data Management
• Ensures compliance with global regulations and ICH guidelines to meet all drug safety and pharmacovigilance reporting requirements
• Oversee preparation, development, implementation and maintenance of company SOPS and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements.
• Knowledge of current US and international regulatory requirements; Maintain current with applicable PV global regulations, and industry guidelines. Responsible for all processes and operating procedures to ensure compliance with appropriate regulations and quality standards
• Serve as the Pharmacovigilance subject matter expert for internal audits and FDA and global regulatory inspections and remediate any pharmacovigilance deficiencies found during regulatory or internal audits. Identify and follow-up on corrective action plans arising from audits and inspections
• Implements PV quality management system including the identification and authoring of required procedural documents
• Collect, analyze metric reports related to ICSRs, aggregate reports to ensure the systems and processes are compliant with the study specific plans, SOP and PV regulations
• Author, review and approve SOPs as required
• Escalate critical and major PV gaps to the management to ensure appropriate action
• Support and participate in PV training of employees as needed
• Demonstrated experience in communicating across several cross functional groups managing business process outsourcing vendors and relationships.

• Previous experience in collection and handling metrics related to PV operations
• Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
• Excellent written and verbal communication skills to a variety of levels and teams, internally and externally.
• Demonstrated persuasion, influencing and negotiation skills.
• Ability to operate objectively and independently as a leader and as a member of matrix teams, as required
• Effective team player, with proven ability to effectively lead projects and teams to successful conclusion

Knowledge, Skills & Capabilities:

• Hands on and motivated leader to drive the risk management and the clinical programs
• Demonstrated ability to influence across a matrix structure, and to collaborate in a cross-functional environment
• Highly organized and proficient in working in matrix team to support business and clinical program needs
• Provides motivational leadership to the organization and improve its performance
• Strong problem-solver and business acumen.

• Strong interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously

Education & Relevant Work Experience:

• Demonstrated ability as a line function manager
• Exposure to and management of significant accelerations and challenges in clinical programs.

• MD or MD PHD with 15 years or more in industry with majority in Pharmacovigilance with prior experience of leading Pharmacovigilance for multiple clinical development programs
• Experience or high comfort level in supporting clinical programs across multiple therapeutic areas, and bridging late to early development, familiarity with gene and/or cell therapy a plus
• Ability to work with the Senior Executive Team and other external audiences such KOLs, regulatory bodies
• Solid knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments
• Strong knowledge of MedDRA and common safety database.
• Demonstrated leadership and technical capabilities with the ability to simultaneously manage multiple different projects.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.