About Provention Bio, Inc:
Provention Bio, Inc. (Nasdaq: PRVB) is a commercial-stage biopharmaceutical company focused on advancing the development and commercialization of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.Position Summary:
The successful candidate will be a member of the clinical development team, working closely with internal and external members of the clinical development group (medical monitor, statistician, clinical pharmacologist, translational research) to support investigations that deliver the development strategies for clinical assets in the pipeline. The individual contributes to the trial development strategy assisting with protocol development and study design and clinical study execution. The key responsibilities are as follows:Responsibilities Include:
- Working with the clinical and regulatory teams, to create key strategic documents including clinical development plans, protocol summary sheets and full protocols for defined product(s) along with amendments and related documents.
- Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/CTA/BLA/MAA submission documents, responses to Health Authorities questions, and contribute to Clinical Development Plans
- Performing medical data review during study execution to ensure integrity of accruing study data and appropriate SAE follow-up. Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
- Assist in setting up and contribute to study-related Advisory Boards.
- Assist in investigators meetings and protocol training meetings.
- Assist in analyzing and interpreting study data from an individual study and translating study level clinical data across the program of studies for a particular drug, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.
- Assist the clinical team in coordinating the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for regulatory or investigator meetings.
- Assist Clinical Operations team in study execution as requested.
- Master's Degree, R.N., PhD, PharmD with clinical trial/drug development Phase 1-3 expertise highly desirable
- The ideal candidate will have 5+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company and/or contract research organization
- Possess scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize
- Proven experience in developing effective relationships with key investigators
- Must have excellent interpersonal, written and verbal communication skills, administrative skills
- Embraces open communication and debate in service of making informed and insightful decisions. Highly approachable and flexible, the successful candidate knows how to break down barriers and promote sharing of information.
- Thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are necessary
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel
- Ability to "roll up your sleeves" and individually contribute results to a development effort
- Ability to travel domestically and internationally as needed.
- Ability to work independently in a virtual home-based position
Provention Bio is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment is decided based on qualifications, merit, and business need.