Responsible for the planning, implementation, execution and management of multiple clinical studies and/or global studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations (CRO) if applicable.

Job Duties and Responsibilities

• Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
• Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
• Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
• Provides oversight and management of CROs, 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 when required.
• Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
• Participates in the 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 team members.
• Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
• 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.
• 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.
• Provides input as the subject matter expert for the assigned studies during regulatory inspections.
• Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
• 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.
• Participate in the preparation, review, updating and training of SOPs.
• Maintain knowledge of oncology 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.

Key Core Competencies

• Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
• Demonstrated skills working within a matrix environment.
• Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan.
• Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
• Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
• Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
• Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
• Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
• Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
• Strong analytical skills with a data driven approach to planning, executing, and problem solving
• Working knowledge of current global regulatory requirements and guidelines for clinical trials.

Education and Experience

• Bachelor’s degree in a related field required.
• M.S./Ph.D. in a related life science discipline is preferred.
• Thorough understanding of the oncology arena.
• Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.

The base salary range for this role is $137,100 to $171,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.