- Analyze and interrogate clinical data from active clinical studies on an ongoing basis.
- Provide continual critical evaluation of ongoing clinical data.
- Interpret data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Review key technical and clinical documents, including but not limited to, clinical study protocols, clinical study reports, investigator's brochures, annual reports, and clinical sections of regulatory submissions.
- In conjunction with the medical director/monitor, be accountable for the scientific aspects of the implementation and conduct of a clinical trial with both internal and external stakeholders (e.g., investigator meeting presentations, data review and summary, protocol deviation review, etc.)
- Assist and collaborate with stakeholders to create and maintain clinical development plans to be aligned with key strategic documents (eg target product profile)
- Assist in the preparation of abstracts, posters, manuscripts, slides for oral presentation for internal and external deliverables.
- Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow efficient execution of clinical studies.
- Work independently as well as contribute as part of an interdisciplinary team.
- Maintain flexibility to meet deadlines and to respond to frequent and/or unexpected changes.
- BSN, MS, PhD, PharmD, MD or equivalent with clinical research experience. (3-5 years minimum. Advanced degree candidates preferred with strong scientific knowledge and skillset.
- Prior industry experience required; oncology experience preferred.
- Broad and solid understanding of functional areas of drug development, including but not limited to the following: preclinical discovery and mechanisms of action, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management)
- Possess highly effective communication skills and be fluent in the English language, both written and verbal.
- Understand, interpret, and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge to support a robust overall clinical development strategy.
- Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness, and the ability to perform as a respected team member and leader.
- Able to work independently and organize priorities and deliverables.
- The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
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Clinical Scientist/Senior Clinical Scientist - Cambridge, United States - LEAP THERAPEUTICS, INC.
Description
Clinical Scientist/Senior Clinical ScientistShare to LinkedIn Apply Now Apply Now
Company Summary:
Leap Therapeutics (Nasdaq:
LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit
General Responsibilities:
Reporting to the VP, Clinical Development, the Clinical Scientist/Senior Clinical Scientist is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies.
The successful candidate will work independently in conjunction with the Medical Director/Medical Monitor and other functional teams in the execution of protocols, analysis of clinical trial data, review of regulatory documents, and summary of key data for internal and external presentations.
Specific responsibilities include:
Education / Experience / Skills:
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.
