Intensity Therapeutics, Inc. a clinical-stage biotechnology company, is focused on the discovery and development of proprietary, novel immune-based intra-tumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers.
We are seeking a highly motivated and experienced Clinical Project Manager with proven skills working in a fast-paced, publicly traded biotechnology company. Selected candidate will be responsible for cross-functional planning and execution of Intensity’s clinical projects, including, managing timelines, cost, quality, risk assessment and mitigation. Incumbent is expected to bring high attention to detail, a collaborative positive work style, and experience in immuno-oncology drug development. Must have proven expertise and experience with successfully resolving problems while also being thoughtful and proactive about risk mitigation. This position reports to the VP, Clinical Operations.
Position responsibilities include:
- Represents and leads the Study Team to design, develop and deliver the study to agreed-upon timelines.
- Provides project coordination and communication in support of cross-functional experts (internally and externally).
- Facilitates decision-making, collaboration, and problem-solving with all levels of the organization to accomplish shared program goals.
- Provides oversight and management of CROs and vendors.
- Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with agreed-upon study plans through regular CRO and/or investigator site contact.
- Monitors progress of clinical activity and reports on progress of assigned clinical trials including budget and timelines.
- Anticipates bottlenecks, clears barriers to progress, conducts project level scenario planning & risk management.
- Coordinates and leads all aspects of internal project meetings, including agenda drafting and clear documentation of key discussion points, decisions, and action items.
- Communicates project information and develops project presentations for senior leadership, and other key stakeholders. Presents on-going study updates to Clinical Leadership.
- Champions best practices in Project Management, including use of agendas, minutes, maintaining document repository, establishing, and implementing templates, tools, and processes to drive efficiency, alignment, communication, and effective planning.
- As needed, supports oversight of contracts and outsourced activities with vendors and business partners.
- Monitors status of clinical data collection of assigned clinical trials.
- Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
- Develops study-related documents.
- Reviews and approves study-related plans generated by CROs/vendors. Ensures documentation is in accordance with GCP, regulatory requirements and consistent with the protocol.
- Assists study team with preparation for audits/inspections.
- Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, and CSRs.
- Prepares and delivers program/study updates.
- Manages escalation of study-related issues and communicates as appropriate to management.
- Evaluates issues found in clinical studies. Communicates effectively and provides oversight of CROs/vendors. Suggests and implements solutions and mitigations as required.
- Anticipates bottlenecks, potential study issues and clears barriers to progress project level scenario planning and risk management.
- Contributes to development of RFPs and participates in selection of CROs/vendors.
- Provides oversight for setup, maintenance, and close out of the Trial Master File and ensures its completion and inspection readiness.
- Assures compliance with internal SOPs, FDA regulations and GCP.
- Provides input as the subject matter expert for assigned studies during regulatory inspections.
- May simultaneously lead/manage more than one clinical trial.
Qualifications and Education Requirements:
- Bachelor’s degree in Life Sciences, Chemical Sciences, Physical Sciences or other relevant discipline or equivalent experience. Advanced degree welcome.
- Minimum of 5 years of experience in biotech/pharmaceutical industry,
- Oncology drug development experience preferred.
- Managerial experience preferred.
- Excellent project management skills – drives execution while balancing speed, quality, and cost.
- Excellent interpersonal skills, including ability to successfully influence individuals in a matrix environment.
- Experience with commonly used project management tools including but not limited to Microsoft Project.
- Understanding of Good Clinical Practice (GCP) guidelines and FDA regulations.