Job details
Job type full-time
Not provided by employer
Full job description
Overview: the senior clinical scientist, reporting to the vice president clinical development, ensures the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partnersThe senior clinical scientist works closely in a matrix with the medical director and other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelinesThe individual in this position supports the establishment and growth of clinical development functions to assure best-in-class global capabilities and execution responsibilities:
Key responsibilities:
Facilitate and execute the creation, update, and/or review of key clinical and regulatory documents, including, but not limited to:
Protocol concepts, synopses, protocols, and amendments
Informed consent documents
Investigator brochures
Clinical study reports
Abstracts, posters, and manuscripts
Clinical sections of inds (and equivalent applications), annual reports, and developmental safety update reports
Clinical study supporting documentations and processes, e.g.: charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, sops, etc.
Supports all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical studiesPartner with relevant functional areas for the successful implementation and execution of clinical studiesSpecific tasks will include but are not limited to the following:
Provide clinical and scientific expertise for selection of investigator and vendors
Train internal colleagues, cro staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, irbs/iecs, health authorities, and cros
Review, query, and analyze clinical trial data
Partner with medical director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the cro or directly with study investigator
Present clinical trial data, both internally and externally
Create clinical study or program-related slide decks for internal and external use
Represent a clinical study or development program on one or more teams or sub teams
In collaboration with the medical director/medical monitor, build and maintain kol/investigator networks; organize and present at kol advisory boards and investigator meetings, engage advocacy groups
Contribute to or perform therapeutic area/indication research and competitor analysis
Build strong relationships with internal experts.
Develop, track, execute and report on goals and objectives.
Be accountable for compliant business practices qualifications:
Educational requirements:
Advanced degree (e.g.: pharmd, phd, or md) within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
Experience and skill requirement:
Minimum of 5+ years of experience and success within the function in other biotech / pharmaceutical companies, with 2-3 years in the oncology therapeutic area.
Previous participation in an early/late clinical development program is essential.
Clinical oncology experience preferred (early phase)/required (late phase).
High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
Knowledge of gcp and ich guidelines
Flexibility to work with colleagues in a global setting
Able to engage in work-related travel approximately 25%
Demonstrated success in working in a global cross-functional environment is a plus
Experience with the development and support of related sops and policies is a plus
Knowledge of industry standard clinical development it solutions expected.
Problem solving and risk-mitigation skills.
Confident, positive attitude, and enthusiastic
Strategic and creative thinker.
Ability to work independently and build working relations throughout the organization and with business partners to achieve business goals.
Strong time management and organizational skills.
Ability to manage multiple projects in a fast-paced environment.
Skilled in multiple computer-based tools, in addition to software programs such as word, powerpoint, excel, etc
Please note: candidates must be local or open to relocating as remote is not an option for some rolesLocal candidates are expected to be on-site 2 days per weekNon-local candidates open to 10-25% travel to woburn office
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Posted 7 days ago
