Scientist, Clinical Sciences

About Affini-T Therapeutics

Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the ultimate goal of inducing long-term responses in patients with solid tumors.

Position Summary

The Clinical Scientist has a pivotal role within the Clinical Science Line Function. The successful candidate will work collaboratively with a dynamic team while directly contributing to clinical science activities to support clinical development programs. The ideal candidate will be a resourceful and matrix-driven individual able to support multiple clinical studies and relationship building with both internal and external stakeholders.

This opportunity requires a critical thinker who takes independent initiative to support program deliverables. The Clinical Scientist will work internally and externally to drive the development and refinement of clinical and scientific processes to ensure clinical trial data are complete, accurate, comprehensive, and consistent.

Essential Duties and Responsibilities

The major tasks for this position are as follows:

• Manage and execute clinical research activities for multiple trials.
• Serve as a Clinical Trial Lead or Co-Lead
• Represent Clinical Science across functional activities and oversee clinical research activities internally and with CROs.
• Serve as a key cross-functional collaborator/contributor.
• Maintain thorough understanding of all assigned protocols.
• Collaborates with medical directors/Clinical Development physicians, clinical operations, clinical data science, and other groups to conduct clinical review of study data; identify and evaluate study data trends, outliers, protocol violations, etc.
• Support study ad-hoc, interim, and final analyses through data review, including oversight of vendor data resulted and reported outside the electronic data capture (EDC).
• Collaborate with the clinical development team on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting.
• Review and present data and information to external investigators and internal stakeholders
• Identify and liaise with internal and external collaborators as needed.
• Author/review abstracts/publications
• Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start-up/conduct/closure), through activities such as:
• Evaluation of innovative trial designs
• Protocol and ICF development
• Site-facing activities
• Contribute to or develop CRA training materials.
• Investigator Meetings, SIVs, Advisory Boards, and Study committee (e.g., DMC) activities
• Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses)
• Track items for inclusion in protocol/ICF amendment and work with other groups to ensure the timely and appropriate completion of protocol amendments.
• Support Medical Directors/Clinical Development Physicians with ongoing data generation to address unmet medical needs and identify new or extended clinical study opportunities.

Desired and Required Qualifications

Education and Experience:

• Clinical/Science degree required; advanced degree preferred.
• Minimum of 4-6 years of clinical drug development experience.
• Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
• Experience leading clinical research activities and overseeing CROs.
• Proficient project management skills
• Oncology experience preferred.

The successful candidate will have the following attributes:

• Excellent interpersonal and communication skills
• Strong attention to detail and organizational skills
• Engage with members of the team in experimental design, troubleshooting, data analysis, data interpretation.
• Work well independently and in collaboration across various teams in the organization.
• Self-starter, able to contribute effectively in a fast-changing environment.
• The ability to work both independently and in a team-oriented environment.
• Highest integrity and work ethics
• Commitment to quality and timely delivery of results
• Maintain accurate and well-organized laboratory notebooks.
• Respect laboratory safety policies and practices

Physical Requirements

• Sit for extended periods of time (2 or more hours)

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