What are the responsibilities and job description for the VP/SVP, Clinical Development Operations position at Kiniksa Pharmaceuticals?
The VP/SVP of Clinical Development Operations will lead the strategic and operational execution of Kiniksa’s clinical development programs across all phases. Reporting directly to the EVP, Chief Operating Officer, this role is critical in bridging clinical strategy with operational excellence and commercial readiness. The VP/SVP will oversee clinical operations, program management, and vendor partnerships, while fostering cross-functional collaboration across R&D, Regulatory, Medical Affairs, and Commercial.
This role is based in our Lexington, MA headquarters, five days in the office.
Responsibilities (including, but not limited to):
- Lead the strategic and operational execution of global clinical development programs across all phases, including registrational and post-marketing studies
- Align clinical operations strategy with corporate objectives, ensuring readiness for regulatory submissions and commercial launch activities
- Oversee clinical operations, program management, and vendor partnerships to ensure timely, compliant, and cost-effective delivery of trials
- Collaborate cross-functionally with Clinical Development, Regulatory, Medical Affairs, and Commercial to integrate scientific and operational plans
- Build and mentor a high-performing clinical operations and program management team, fostering a culture of accountability and innovation
- Develop and implement scalable processes, systems, and SOPs to support clinical growth and regulatory compliance
- Select, negotiate, and manage relationships with CROs, central labs, and other external partners; establish governance models and performance metrics
- Manage clinical development budgets, forecasts, and resource allocation; provide executive-level reporting on program status, risks, and milestones
- Serve as a key contributor to portfolio-level planning and strategic decision-making within the R&D and operational leadership teams
Qualifications:
- Advanced degree (PhD, MD, PharmD, or MS) in life sciences or related field preferred
- Minimum 15 years of experience in clinical development, with at least 5 years in a senior leadership role
- Proven success in leading global clinical programs through regulatory milestones and commercialization
- Deep knowledge of GCP, ICH guidelines, and global regulatory environments
- Experience in rare disease
- Strong leadership, communication, and strategic planning skills
- Demonstrated ability to manage complex cross-functional initiatives and external partnerships
- Comfortable operating in a fast-paced, growth-oriented environment with a high degree of autonomy
- Inspirational people leader with excellent communication, decision-making, and change management skills
- Mission-driven, solutions-oriented, and thrives in a fast-paced biotech setting
- Ability to travel up to 10%
- Salary is commensurate with experience
- Kiniksa Benefits Summary - USA
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
