Job Description

SUMMARY:

The Senior Director, Clinical Science will report to the Chief Medical Officer. The Head of Clinical Science will be responsible for the design and interpretation of Xilio clinical studies. This work supports the progression of therapies from IND through registration. The Head, Clinical Science will be responsible for the clinical development strategy including protocol development and oversight. The successful candidate will have wide-ranging responsibilities and the ability to work within a highly collaborative, dynamic, and interdisciplinary team.

Responsibilities

Responsible for the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents (eg. SAP, eCRFs)
Responsible for the oversight of study execution in collaboration with Clinical Operations lead and internal/external study team members (ie. biostatistics/programming, data management, pharmacovigilance, medical writing, clinical pharmacology, and translational research)
Responsible to review, analyze, and interpret study results and ensure appropriate data review and accurate data reporting
Responsible to identify study/program issues by reviewing and monitoring emerging clinical safety and efficacy data; Develop sound, strategic solutions to issues and lead issue resolution
Lead preparation of advisory board meetings, and KOL interactions; lead development of clinical publications (eg. presentations at scientific meetings)
Responsible to support regulatory interactions including contributing to briefing documents, presentations, addressing questions and responses
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and XILIO SOPs, for all products and services delivered for their designated studies
Responsible for cultivating strong relationships and robust communication among the clinical study/project team and XILIO’s Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials
Serves as a product, protocol and project subject matter expert to support internal and external customers
Work with external experts to develop abstracts, manuscripts and study design presentations
Work in a strategic and facilitative role by leveraging clinical development expertise in providing support to the CMO
Serve as clinical representative on product development team
Lead Clinical Scientist function and oversee multiple functional groups in accordance to corporate objectives and LRP
Contribute to the development of corporate infrastructure, SOPs, and processes that are reflective of the size and scale of the organization

Qualifications

Advanced degree (e.g. MS, PhD, PharmD)
Experience in a pharmaceutical industry or CRO environment in clinical development operations
Oncology clinical development experience
In depth knowledge of regulatory guidelines and ICH/GCP
Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
Clinical development experience across all phases of development (I-IV)
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams
Experience in managing external vendors
Excellent verbal and written communication skills with ability to function within cross functional teams

Valid through: 3/22/2021