- Translate preclinical discoveries into viable oncology therapeutics by supporting clinical development trials and programs within TP Therapeutics’ portfolio
- Support corporate strategy and clinical development department deliverables for clinical trials and programs by helping with design of scientifically sound clinical protocols and ensuring decision quality clinical data is being generated on an ongoing and timely basis
- Support clinical development deliverables of determining and measuring optimal pharmacodynamic outputs and enhancing science based patient selection strategies
- Support the program’s medical monitor/director in the design, conduct, and assessment of the clinical studies including assessment of safety signals as required
- Develop and maintain strong working relationships with investigators and KOL’s and conduct thorough analyses of current standard of care in focused therapeutic areas to support advisory boards and development plans
- Conduct literature searches, draft regulated clinical documents, publication abstracts, presentations and publications
- Support the execution of clinical trials on time by working in a multi-disciplinary team setting with members from within company, CROs and consultants
- This job role does not require individual to be medically qualified.
- Scientific writing: Author or contribute to production of high-quality documents or sections thereof that are scientifically sound:
- Clinical protocols and amendments
- Clinical study reports
- Investigator brochure
- Documents to support health authority interactions including DSURs
- Publications including abstracts and congress presentations
- Translational medicine: Support development of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support development of stratification biomarkers.
- Decision quality data generation:
- Partner with data management and study medical monitor/ director for CRF design, instructions, data review plan and conduct frequent clinical data listing review
- Partner with biostatistics and study medical monitor/director for statistical analysis plan review and finalization
- In conjunction with study medical monitor create and/or review slides for internal and external meetings such as investigator meetings, SIVs, company-wide meetings
- Participate in long-term clinical development and planning a pathway to regulatory registration for assigned therapeutic area(s)
- Serve as clinical science representative on cross-function teams as assigned
- Be able to multi-task, prioritize and be a self-starter
- This is an important, high profile role in a fast growing clinical development organization.
- An advanced science degree (eg. PhD, PharmD)
- 0-3 years of clinical trial experience in industry; experience working on cross-functional teams, closing a clinical study and authoring a clinical study report preferred
- Highly motivated entry-level candidates will be considered with commensurate experience in working in industry in cross-functional teams, working on research protocols in industry setting and adhering to tight timelines; course-work covering fundamentals of GVP, ICH and familiarity with FDA guidelines preferred
- Strong communication skills and ability to work effectively across multiple multidisciplinary teams.
- Excellent oral and written communication skills.
EEO & Employment Eligibility
- TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
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