• Support the program’s medical monitor/director in the design, conduct, and assessment of the clinical studies including assessment of safety signals as required
• Work closely with the clinical sites, CROs, and internal clinical team (medical monitor; clinical operations team; data manager; and statistician) on the delivery of clinical data; interpretation of the data and overall data cleaning with the internal team
• 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
• Work closely with the medical writers in the evaluation of the clinical data and drafting of the clinical study reports (CSRs)
• 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
• 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
• Key point person with the clinical sites, CRO and medical monitor on the execution of the clinical trials; data delivery; data cleaning activities; and data interpretation
• 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
• 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.
• 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, MS)
• Clinical trial experience in clinical development within pharmaceutical industry is a must have (at least 1 year); experience working on cross-functional teams, closing a clinical study and authoring a clinical study report preferred
• Strong communication skills and ability to work effectively across multiple multidisciplinary teams.
• Excellent oral and written communication skills.
EEO & Employment Eligibility
Turning Point 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. Turning Point 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. Turning Point Therapeutics is an E-Verify employer.
To apply, please submit your resume to email@example.com