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Senior Clinical Research Scientist
777 Scudders Mill Road Building 2, Plainsboro, NJ 8536 Plainsboro, NJ 8536 US
Job Description
Responsibilities:
- Contribute to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds
in various stages of clinical development (e.g. clinical trial implementation), and oversight of all aspects of clinical development working closely with the
Medical Director and other cross-functions to provide high-quality and timely deliverables
-Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
- In collaboration with the Medical Director, contribute to the development of clinical and regulatory documents,
annual safety updates, and registration dossiers (i.e., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions) to support registration and commercialization of the compound(s)
- Participate in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities)
- Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
- Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
- Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
- Participate in the development and review of study plans and serve as a liaison to project teams and CROs
- Provide input for the development of publications in coordination with Scientific Communications
- Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
- Mentor junior level Clinical Research Scientists as required
Qualifications:
- PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
- Minimum requirement: 6+ years of experience in clinical research with at least 3 or more years of drug development experience (preferably in oncology/hematology)
- Experience working in a project-oriented matrixed team environment
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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