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Senior Director, Clinical Sciences

2 months ago

Watertown, United States Affini-T Full time
Job DescriptionJob DescriptionAbout Affini-T Therapeutics
Affini-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 Summary
In 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 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
  • Key stakeholder for clinical data analysis including but not limited to ad-hoc, interim, and final analyses
  • 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
  • Lead 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 advice
  • Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management
  • Author/review abstracts and 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; 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 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
  • Cell therapy experience preferred
The successful candidate will have the following attributes:
  • Excellent interpersonal and communication skills
  • Strong attention to detail and organizational skills
  • Demonstrated ability to partner with members of the team in experimental design, troubleshooting, data analysis and data interpretation
  • Self-starter, able to contribute effectively in a fast-changing environment
  • The ability to work both independently and in a collaborative environment
  • Highest integrity and work ethic
  • Commitment to quality and timely delivery of results
  • Proven ability to maintain accurate and well-organized laboratory notebooks
  • Skilled at ensuring laboratory safety policies and practices are being adhered to

 

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