Associate Director, Pharmacovigilance Planning and Innovations

Kailera is seeking an Associate Director, Pharmacovigilance Planning and Innovations to ensure operational effectiveness, project planning, and cross-functional alignment of global patient safety and pharmacovigilance activities. This role involves leading the integration of innovative technologies, driving process optimization, and managing cross-functional initiatives from concept to adoption. The ideal candidate will combine pharmacovigilance expertise with strong project management, stakeholder leadership, and business acumen to advance novel therapies for obesity and related conditions.

Must Have

• Coordinate and lead departmental planning activities for PSPV organization.
• Lead end-to-end project management for PV initiatives, including system implementations and process improvements.
• Develop and maintain project plans, metrics, and dashboards for PSPV strategies.
• Support resource forecasting, alliance management, and vendor oversight.
• Facilitate cross-functional meetings, track actions, and ensure on-time project execution.
• Communicate project updates to internal and external stakeholders.
• Ensure project outcomes align with PV strategy and corporate objectives.
• Build strong relationships with cross-functional leaders to foster a proactive safety culture.
• Manage cross-functional alignment for operational effectiveness and PV system/process evolution.
• Develop and maintain the pharmacovigilance innovation roadmap.
• Assist with developing and implementing innovative technical or procedural solutions.
• Facilitate maintenance of governance structures like the Medical Safety Board.
• Support GCP and GVP inspection readiness and audits.
• 10+ years experience in biotech, pharma, or CRO with pharmacovigilance/drug safety focus.
• 3+ years project/program management experience in a regulated environment.
• Demonstrated project management, analytical, and problem-solving skills.
• Exceptional communication, stakeholder engagement, and change management skills.
• Strong interpersonal, organizational, and strategic planning abilities.
• Experience with outsourced vendors or Contract Research Organizations (CROs).
• Experience leading or supporting process improvement initiatives.
• Adaptable to changing priorities across multiple clinical trials and deliverables.
• Adept at communicating departmental vision and aligning activities with corporate goals.
• Proficient in computer skills including Word, PowerPoint, Excel, Visio, and Power BI.
• Proven ability to work independently with minimal supervision.
• Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP).

Good to Have

• Experience in other drug development areas (regulatory affairs, quality assurance, alliance management).
• Hands-on experience with safety databases (e.g., Argus), PV quality systems, and regulatory inspections.
• Familiarity with AI/ML and NLP in regulated settings.

Perks & Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You Will Do:

Reporting to the Senior Vice President, Patient Safety and Pharmacovigilance, this individual will play a critical role in ensuring the operational effectiveness, project planning, and cross-functional alignment of global patient safety and pharmacovigilance activities. Lead and support the integration of innovative technologies, drive process optimization, and other cross-functional initiatives from concept to adoption. Combine knowledge of pharmacovigilance practices with strong project management, stakeholder leadership, and business acumen.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Coordinate and lead departmental planning activities for the PSPV organization including, e.g., headcount modeling, organizational design, and pharmacovigilance projects
• Lead end-to-end project management for PV initiatives, including system implementations, process improvements, compliance programs, and organizational change efforts
• Develop and maintain project plans, metrics, and dashboards to support PSPV strategies
• Support resource forecasting, alliance management, and vendor oversight
• Facilitate cross functional meetings, track actions, and ensure on-time execution of project deliverables
• Communicate project updates to internal and external stakeholders through clear status reports, presentations, and dashboards
• Ensure project outcomes align with PV strategy and broader corporate objectives
• Build strong working relationships with cross functional leaders to support a proactive and collaborative safety culture
• Manage and coordinate cross functional alignment for operational effectiveness and PV system/process evolution
• Develop and maintain the pharmacovigilance innovation roadmap aligned with cross functional initiatives and compliance requirements
• Assist with the development and implementation of innovative technical or procedural solutions to improve PSPV operational capabilities
• Facilitate the maintenance of governance structures (e.g., Medical Safety Board)
• Support in GCP and GVP inspection readiness and support audits

Required Qualifications:

• 10+ years of experience in biotech, pharma or CRO with a demonstrated focus on pharmacovigilance, drug safety, or related field
• 3+ years of project or program management experience in a regulated environment
• Demonstrated project management skills with strong analytical and problem-solving capabilities
• Exceptional communication, stakeholder engagement, and change management skills
• Strong interpersonal, organizational, and strategic planning skills
• Experience working with outsourced vendors or Contract Research Organizations (CROs)
• Experience leading or supporting process improvement
• Adaptable to changing priorities and across multiple clinical trials and deliverables
• Adept at communicating departmental vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate objectives
• Proficient computer skills, including Word, PowerPoint, Excel, Visio, Power BI or similar.
• Proven experience working independently with minimal supervision
• Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)

Preferred Qualifications:

• Experience in other areas of drug development such as regulatory affairs, quality assurance or alliance management
• Hands-on experience with safety databases (e.g., Argus), PV quality systems, and regulatory inspections
• Familiarity with AI/ML and NLP in regulated settings

Education:

• Bachelor’s degree or equivalent in Life Sciences, Public Health, Business or other related fields is required. MBA, PhD, PharmD, RN or Master’s degree are preferred

Salary Range

$160,000 - $200,000 USD

This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.