| Location | Boston, MA |
Overview
The Director Clinical Scientist is an important and visible member of the Clinical Development team, working collaboratively with the Clinical operations lead and medical director. The Director Clinical Scientist will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Early- stage portfolio. The role is the primary contact for internal and external stakeholders for clinical aspects of the protocol, supporting strategic development, providing final recommendations to senior management.
Responsibilities
Supports the clinical lead or in some instances serve as clinical lead of early phase program(s)
Independently leads clinical execution of one or more studies. May be accountable for program level clinical deliverables.
Leads development of the protocol, and associated amendment(s) ensuring high level of quality, and operational delivery. Partners with or support from Clinical Lead in governance review and approval process.
Leads development, review or approval of key documents such as the Informed Consent Documents (ICD), Investigator Brochure, Investigators Letters, and safety documents.
Leads the development of recommendations on strategies to internal committees
Provides scientific/medical guidance to the study team, including the CRO team
Reviews safety data, serious adverse events (SAE) reports, and authors or reviews safety or regulatory documents and updates them as required. Tracks SAE and leads presentation of data during Safety Review Team meetings.
Collaborates with research scientists and translational scientists to provide clinical input in crafting and evaluating data to support development of pre-clinical compound(s)
Leads the development and review of content and quality of publications and inputs to development of the publication strategy
Leads the examination and interpretation of clinical data at the study and program level. Author or reviews the Clinical Study Report including the review of narratives.
Attends (in person or by TC) the Site Initiation Visits, to present the study design and key aspects of the protocol
Leads the compilation and analysis of the data for and from the dose critical issue committee/safety review committee, in collaboration with the program physician
Develops, builds and maintains investigator and site relationships to support site selection and study start up activities
Represents the project internally and supports drug development externally as a medical scientific expert with key external experts. Supports development of alliances as appropriate.
Qualifications
Ph.D., PharmD or a Masters degree in a relevant Clinical or Biomedical field.
8 plus years of clinical drug development or medical research experience within a pharmaceutical/biotech or academic environment
Oncology or immunology experience
Advanced understanding of clinical practice across tumor types and how clinical practice is evolving with the introduction of new therapies.
Understanding of cancer cell biology.
Experience leading delivery and influencing at senior leadership levels both internally and externally
Experience in working and leading in matrix teams
Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and lead through conflict
Proven ability in problem solving and issues management that is solution focused
Experience in collaborating externally in terms of clear requirements for collaborative contracts, influencing delivery and scientific engagement.
Effective communication, presentation and organizational skills to ensure coordinated and timely delivery of projects
Demonstrated scientific writing skills
Embraces Artificial Intelligence and other evolving technologies and adopts best practices aimed at improving efficiency and quality of clinical practice
Proven team leadership experience in a clinical setting (2-3 years)
Ability to work proactively and independently, organizational skills, prioritizes self and others.
Ability to support and mentor junior team members