Cleave BioSciences is a clinical development stage biotech company focused on disrupting protein homeostasis for the treatment of specific cancers. Cleave is seeking a highly motivated Clinical Science/Medical Monitor to be a key member of a fast-paced and dynamic organization.
The candidate will work in a highly dynamic and fast-paced environment. Candidate must have excellent record keeping skills as well as written and verbal communication skills, organizational skills, flexibility and the ability to work in a team environment.
• Translate preclinical discoveries into viable oncology therapeutics by overseeing and supporting appropriate clinical development trials and programs within Cleave’s portfolio
• Support corporate strategy and clinical development department deliverables for clinical trials and programs by designing scientifically and medically 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
• Assume or support the role of 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
• Medical monitor (for MD hires): Be accountable for overall subject safety on clinical trial protocols by designing appropriate studies, ensuring subjects that meet criteria are enrolled and monitoring for emerging safety signals. Participate in periodic safety reviews to define the safety profile of study drugs.
• Scientific writing: Author or contribute to production of high-quality documents or sections thereof that are scientifically and medically 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 by partnering closely with study’s biometrics team to ensure clinical data is clean with an appropriate statistical analysis plan
• In conjunction with or as the 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)
• MD degree preferred; and required for medical monitor roles
• 3-5+ years of clinical trial experience in industry preferred; experience working on cross-functional teams, closing a clinical study and authoring a clinical study report preferred; title based on experience
• Familiarity with GCP, ICH and FDA guidelines requirements for drug development
• IND/CTA, NDA/MAA submission experience preferred
• Strong communication skills and ability to work effectively across multiple multidisciplinary teams.
• Excellent oral and written communication skills.