Affini-T
Senior Director, Clinical Sciences
Affini-T, Watertown, Massachusetts, us, 02472
About Affini-T TherapeuticsAffini-T Therapeutics is a clinical stage biotechnology company focused on building a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop solid tumor therapies. Through the application of gene editing and synthetic biology, we focus on enhanced T-cell fitness to overcome the immunosuppressive tumor microenvironment.
Job SummaryIn a highly collaborative environment, the (Sr) 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. They 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. They 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. They will ensure effective alignment of clinical-scientific approaches with other business processes and regulatory requirements for inspection readiness.
Essential Duties and ResponsibilitiesManage and execute clinical research activities for multiple trialsServe as a Clinical Trial Lead or Co-LeadRepresent Clinical Science across functional activities and oversee clinical research activities internally and with CROsServe as a key cross-functional collaborator/contributorSupport authoring of the clinical development plan (CDP) and target product profile (TPP)Lead implementation of assigned clinical development plansMaintain an advanced understanding of all protocols within assigned programProvide scientific and clinical leadership to support all activities to advance the assigned plans; provide program/study/therapeutic area/skills training to team membersKey stakeholder for clinical data analysis including but not limited to ad-hoc, interim, and final analysesSupport resourcing and budget planning activities for teamCollaborates 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 inquiriesReview and present data and information to external investigators and internal stakeholdersLead execution for, or key contributor to relevant clinical advisory board interactions, safety monitoring committee meetings, DSMB meetings, etc.Identify and liaise with internal and external collaborators and oversee collaboration between clinical scientist and external partners for scientific adviceLead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. ManagementAuthor/review abstracts and publicationsOversee, 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; ensuring consistent quality data review across trial teams, investigator meetings, SIVs, advisory boards, 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 amendmentsSupport PD Medical Directors/Clinical Development Physicians with ongoing data generation to address unmet medical needs and identify new or extended clinical study opportunitiesConduct literature searches and track trends in cell therapies and provide competitive intelligence to the program team
Desired and Required QualificationsAdvanced clinical/scientific degree (e.g., PharmD, PhD, MSN, MPH)Minimum 5 years of global experience in clinical drug developmentSound 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 regulationsExperience leading clinical research activities and overseeing CROsProficient project management skillsOncology experience preferredCell therapy experience preferred
The successful candidate will have the following attributes:Excellent interpersonal and communication skillsStrong attention to detail and organizational skillsDemonstrated ability to partner with members of the team in experimental design, troubleshooting, data analysis and data interpretationSelf-starter, able to contribute effectively in a fast-changing environmentThe ability to work both independently and in a collaborative environmentHighest integrity and work ethicCommitment to quality and timely delivery of resultsProven ability to maintain accurate and well-organized laboratory notebooksSkilled at ensuring laboratory safety policies and practices are being adhered to
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Job SummaryIn a highly collaborative environment, the (Sr) 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. They 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. They 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. They will ensure effective alignment of clinical-scientific approaches with other business processes and regulatory requirements for inspection readiness.
Essential Duties and ResponsibilitiesManage and execute clinical research activities for multiple trialsServe as a Clinical Trial Lead or Co-LeadRepresent Clinical Science across functional activities and oversee clinical research activities internally and with CROsServe as a key cross-functional collaborator/contributorSupport authoring of the clinical development plan (CDP) and target product profile (TPP)Lead implementation of assigned clinical development plansMaintain an advanced understanding of all protocols within assigned programProvide scientific and clinical leadership to support all activities to advance the assigned plans; provide program/study/therapeutic area/skills training to team membersKey stakeholder for clinical data analysis including but not limited to ad-hoc, interim, and final analysesSupport resourcing and budget planning activities for teamCollaborates 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 inquiriesReview and present data and information to external investigators and internal stakeholdersLead execution for, or key contributor to relevant clinical advisory board interactions, safety monitoring committee meetings, DSMB meetings, etc.Identify and liaise with internal and external collaborators and oversee collaboration between clinical scientist and external partners for scientific adviceLead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. ManagementAuthor/review abstracts and publicationsOversee, 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; ensuring consistent quality data review across trial teams, investigator meetings, SIVs, advisory boards, 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 amendmentsSupport PD Medical Directors/Clinical Development Physicians with ongoing data generation to address unmet medical needs and identify new or extended clinical study opportunitiesConduct literature searches and track trends in cell therapies and provide competitive intelligence to the program team
Desired and Required QualificationsAdvanced clinical/scientific degree (e.g., PharmD, PhD, MSN, MPH)Minimum 5 years of global experience in clinical drug developmentSound 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 regulationsExperience leading clinical research activities and overseeing CROsProficient project management skillsOncology experience preferredCell therapy experience preferred
The successful candidate will have the following attributes:Excellent interpersonal and communication skillsStrong attention to detail and organizational skillsDemonstrated ability to partner with members of the team in experimental design, troubleshooting, data analysis and data interpretationSelf-starter, able to contribute effectively in a fast-changing environmentThe ability to work both independently and in a collaborative environmentHighest integrity and work ethicCommitment to quality and timely delivery of resultsProven ability to maintain accurate and well-organized laboratory notebooksSkilled at ensuring laboratory safety policies and practices are being adhered to
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