Director, Pharmacovigilance Operations & Quality

Position Purpose:

We are seeking a Sr. Director, PV Operations & Compliance to create, direct and manage the company’s PV infrastructure in support of its first commercial product for a first-in-class antisense oligonucleotide (ASO) therapy in a rare pediatric neurological disease. The Sr. Director, Pharmacovigilance Operations & Compliance is a newly created role and a genuine opportunity to shape the scientific infrastructure of PV department at a critical inflection point.

This position is accountable for PV operations for Stoke which includes oversight of safety operations across the portfolio including case processing, database strategy, vendor oversight & governance, inspection readiness, contracts, training and operational strategies related to safety data exchange agreements for the company’s business partners and alliances. The candidate will work collaboratively with internal staff in defining and implementing operational infrastructure and strategies and must build and maintain effective relationships with key strategic internal and external stakeholders including the hiring and training of PV personnel. The role is best suited for someone who is comfortable operating in a small, fast-paced biotech environment. This position reports to the Vice President, Pharmacovigilance.

Key Responsibilities:

• Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
• Direct the development of the PV quality management system including SOPS, Work Instructions, and other guidance documents, in collaboration with internal PV and Quality personnel.
• Establish and maintain oversight and coordination of PV activities (e.g., contracts, safety data exchange agreements, training, reconciliation related to organized data collection systems used by the company (e.g., Market Research, investigator-run-trials, Compassionate Use/Expanded Use, Patient Support Programs)
• Own the strategic design and implementation of the company’s PV training program, spanning internal staff, field staff and external partners including patient support programs, specialty pharmacy distributors, and market research vendors, with role-specific content. Partner with Legal, Compliance, Commercial and Medical Affairs to embed training requirements into vendor contracts and onboarding, with KPIs to track effectiveness through commercial launch and beyond.
• Lead effective vendor management strategies for PV-related activities. Develop effective business models optimizing internal and contract resources and ensure adequate documentation of vendor oversight.
• Establish and oversee implementation of company standards related to post-marketing surveillance, track productivity and monitor quality /cost of outsourced activities related to AE case processing.
• Lead development and maintenance of compliance monitoring systems including metrics tracking for activities in PV (e.g., submission of individual case safety reports to regulatory authorities and distribution to business partners, aggregate report submission)
• Establish processes, tools and tracking mechanisms for PV department deviations ensuring appropriate corrective and preventative actions are in place with timely resolution of findings.
• Hire, manage and supervise activities of direct reports; conduct ongoing performance reviews and development of staff.
• Ensure compliance with global PV regulations and reporting requirements.
• Oversee operational support for DSURs, PBRERs/PSURs, PADERs, and other safety deliverables.
• Responsible for PV budgets, MSA and SOW with PV vendors.
• Contribute to inspection readiness for Stoke’s pharmacovigilance function.

Required Skills & Experience:

• Bachelor’s degree in life sciences/pharmacy/nursing degree or related field; advanced degree (MS, PharmD or equivalent) preferred.
• Minimum of 12 years of progressive responsible pharmacovigilance experience including a combination of PV operations and PV quality experience; minimum of 5 years in a leadership role
• Significant experience with outsourced operating models and vendor governance.
• Experience in PV processes for vendor oversight, individual case handling, aggregate reports, and audits/inspections
• Experience leading and contributing to process improvements, quality management systems, inspection readiness, Health Authority audits, SDEA negotiations.
• Proven track record building internal PV operations/compliance capabilities in a fast-paced, innovative environment
• Deep knowledge of global PV regulations, GVP, FDA regulations, and ICH guidelines.
• Experience and extensive working knowledge of MedDRA, WHODrug, and safety databases (e.g., Argus, ARISg).
• Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail
• Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

Location(s):

This position has a flexible work arrangement, with regular presence at our Waltham office. At Stoke, we value in-person time together for the work that benefits most from it. Expect to be in the office a couple of days most weeks.

Travel:

This position will require approximately 10% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive, and thoughtfully designed total rewards program.

The anticipated salary range for this role is $230,000 - $265,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance, and participation in our Employee Stock Purchase Program (ESPP).