Boston, MA

Position: Clinical Operations (Associate Director – Director)

Position Summary

Karuna is seeking an experienced and motivated Associate Director - Director, Clinical Operations, to join our rapidly growing organization. Reporting to the Senior Director, of Clinical Operations, this critical position will be responsible for the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations. Leading global studies and CROs, including in Asian markets, will be a critical component of the job. This role provides the opportunity for the right candidate with the chance to truly make an impact on the lives of patients and future success at Karuna.

Responsibilities

• While working closely with the Senior Director of Clinical Operations, plans and communicates with cross-functional areas to ensure proper execution and conduct of assigned clinical trials, generating quality clinical data.
• Serves as primary study contact and resource for alliance partners, CRO and vendor personnel in overarching functions as well as team members in Karuna.
• Provides oversight and management of CROs, alliance partners, consultants, and vendors.
• Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
• Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
• Monitors the status of clinical data collection of assigned clinical trials.
• Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
• Prepares and reviews study-related documents as required.
• Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
• Participates in the creation, review, and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
• Participates in meetings – i.e., Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
• Reviews correspondences and monitoring reports relating to the studies.
• Prepare and deliver program/study updates.
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other Karuna team members.
• Monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team members.
• Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
• Provides input into contracts, work orders and/or change orders.
• Provides input into clinical resource requirements to deliver the work.
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
• Ensures assigned studies adhere to all applicable regulations and requirements.
• May perform periodic visits to sites and/or vendors to assess progress and compliance.
• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.
• Provides input as the subject matter expert for the assigned studies during regulatory inspections.
• Establish collaborative and productive relationships with internal/external partners.
• Evaluates issues found in clinical studies, communication, and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
• Evaluate CRO and vendor performance and support the improvement initiatives.
• Maintain knowledge of neuroscience therapeutic area, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities.
• May mentor other team members.
• Perform other duties as requested by the senior management.

Required Qualifications

• Requires a BA/BS preferably in nursing, biology, biochemistry, or life sciences (advanced degrees desirable).
• At least 12 years of experience in direct project management of studies within clinical research operations.
• Leading cross-functional teams for a minimum of 3-5 years.
• Experience with agency submissions and inspections highly preferred.
• Experience in phase I-III clinical studies.
• Global experience, including studies conducted in China, desired.
• Understands and ensures adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations, with strong understanding of and experience in agency inspection readiness.
• Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions.
• Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs.
• Demonstrated project and study management expertise, including the leadership of cross functional study teams and alliance partners.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Attention to detail and quality are critical to success.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
• Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
• Forward thinking mindset with an aptitude and willingness to work in new platforms.
• Proven ability to manage multiple projects, and ability to identify and analyze complex issues and develop relevant and realistic plans and recommendations for resolution.
• Broad experience in an emerging, publicly traded company environment is a plus.

The successful candidate will also embody our values:

Our purpose is to create value for those we have the privilege to serve:

• We take pride in our work
• We keep our promises and deliver
• We are driven to meaningfully innovate
• We succeed through inclusion and teamwork

Karuna Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Karuna Therapeutics requires all employees be fully vaccinated by an approved vaccine against COVID-19, including a booster dose if it has been more than eight months since the employee’s original vaccination, unless you need an exemption due to disability, pregnancy or conditions related to pregnancy or religion or unless otherwise provided by law; in the case of exemption, weekly testing will be required.