Director, Clinical Science

Position Summary At Affini-T, we are passionate about bringing transformative cell therapies to patients with incurable cancers by unlocking the power of T cells against oncogenic driver mutations.

We are focused on patients and driven by science and innovation.

In a highly collaborative environment, the Director, Clinical Science, is an essential role that assumes leadership, ownership, and accountability for all clinical science activities to support clinical development programs.

The ideal candidate will be responsible for clinical documentation of clinical trials.

He/she will represent clinical development on various sub-teams or other appropriate forums, support training of study site personnel, and act as a primary point-of-contact for questions and inquiries about clinical studies or programs.

He/she will assess and oversee the scientific capabilities of clinical CROs, conduct ongoing medical/safety data reviews, and provide clinical science input into study reporting.

The ideal candidate will provide the necessary expertise to design and deliver clinical studies and programs, as well as build the overall clinical trial readiness in close collaboration with other functions.

He/she will ensure effective alignment of clinical-scientific approaches with other business processes and regulatory requirements for inspection readiness.

This role reports to the VP, Clinical Development.

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 Support authoring of the clinical development plan (CDP) and target product profile (TPP) Lead implementation of assigned clinical development plans Maintain an advanced understanding of all protocols within assigned Program Provide scientific and clinical leadership to support all activities to advance the assigned plans; provide program/study/therapeutic area/skills training to team members Support resourcing and budget planning activities for team 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 violators; develop and communicate relevant medical inquiries Review and present data and information to external investigators and internal stakeholders Identify and liaise with internal and external collaborators and oversee collaboration between clinical scientist and external partners for scientific advice Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr.

Management 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 CRA training materials Data quality activities; ensure consistent, quality data review across trial teams 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 PD Medical Directors/Clinical Development Physicians with ongoing data generation to address unmet medical needs and identify new or extended clinical study opportunities Conduct literature searches and track trends in cell therapies and provide competitive intelligence to the program team Desired And Required Qualifications Education and Experience: Advanced clinical/scientific degree (e.g., PharmD, PhD, MSN, MPH) Minimum 5 years of global experience in clinical drug development 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) Occasionally lift or carry up to 20 kg Powered by JazzHR m5AY3akP6x SDL2017