Senior Clinical Project Manager, Medical Affairs

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website *** (***+) or follow us on LinkedIn (/c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2F%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Clinical Project Manager, Medical Affair. The Senior Clinical Project Manager will be responsible for the execution and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations (CRO) if applicable. This includes oversight of Investigator Initiated Studies (IIS), Collaborative Research and Expanded Access Programs.

Job Duties and Responsibilities

• Cross functional collaboration with Clinical Operations

• Administers the IIS/Collaborative Research/Expanded Access program and ensure applicable documentation is filed and retained

• Collaborates with Clinical Business Operations to negotiate and finalize the Clinical Trial Agreement and budget with Investigator including documenting milestones

• Monitors the progress of IIS/Collaborative Research/Expanded Access program by obtaining updates from the Investigator including milestone achievements, study drug accountability and patient enrollment data

• Presents IIS/Collaborative Research/Expanded Access program status at applicable Medical Affairs meetings

• Confirms completion of all deliverables per study contract

• Obtains manuscripts, abstract or presentations from Investigator for internal review for legal and IP interests and safety statements

• Represents and leads the study team to design, develop and deliver the clinical study according to timelines.

• Supports the CyberGrants Portal submissions and serves as back up for the Administrator.

• 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.

• 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.

• Monitors progress of clinical study 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 to ensure best practice across all activities.

• May Mentor other team members.

• Perform other duties as requested by 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.

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.