Location: Cambridge, MA
Contract: 10 months
This key individual will report directly into the project physician or project head, and will interface directly with the medical, writing, and operational functions to support the development of novel anti-cancer therapeutics. Specifically, he or she will Contribute to (assist the clinical lead in) the clinical development plans for new compounds in collaboration with the project MD or project head, including review of the preclinical package Help author and review protocol and study design, amendments, IB(Investigator's brochure), clinical sections of IND(Investigating New Drugs) OR IMPD (Investigational Medicinal Product Dossier) and CTAs fillings(clinical trial application), annual reports, clinical study reports, and risk-management plans, and regulatory documents (INDs, NDAs New Drug Application ) under the guide of the project physician or project head.
Closely liaise with operational group to ensure study design feasibility
Seek collaboration/input from key line functions
Assist in preparation of regulatory responses
Identify core competencies of potential study sites for all phases of oncology trials from a scientific/strategic perspective (distinct from the evaluation given by clinical operations)
Assist in the conduct of study site initiation visits (preparation, personnel training, etc.) and study start-up + close-up meetings, global investigator meetings (preparation of the scientific and medical communication).
Present and discuss project and study strategy with key internal stakeholders, KOLs (key opinion leaders), advisory boards
Assist study physician / project head with a review of the safety and efficacy data (DDR, PV, coding when appropriate)
Provide operational oversight for:
Clinical data review and interpretation
Study manual/study tools
Routinely interface with discovery, safety sciences, statistics, PK (pharmacokinetics), pharmacovigilance (e.g. SAEs and narratives), regulatory, health economic (studies, planning, questionnaires administration), development operations and clinical operations and other members of the extended project team to deliver studies on time and within budget
Author and review clinical abstracts, presentations for conferences when appropriate and assist with writing and managing manuscripts for completed studies.
Provide feedback to the team with data from the clinical study (contribute to discussions regarding adjustments in the study and/or strategy based on the data
Skills & Qualification:
Ph.D. in a related field or Pharm.D with at least 5 years of post graduate experience, of which at least 3 years include direct involvement with clinical research, is required.
In exceptional circumstances individuals without a PhD or PharmD but with significant relevant experience will also be considered. Oncology experience is requested.
The usual verbiage in terms of teamwork, indirect influencing, working in a matrix, communication skills, etc.