Website Johnson & Johnson
The Director, Clinical Project Scientist develops and drives the goals and activities of Clinical Research department such as designing, planning, developing and monitoring of clinical evaluation projects. Interprets research results and evaluates the safety, marketability and medical usefulness of drug and product candidates. Responsible for the compliance of department, company and regulatory standards and procedures.
- Executes clinical research strategies and contributes to the development and execution of clinical research programs.
- Directs study design, protocol development and implementation of clinical studies.
- Defines clinical study parameters, supports deliverables, policy compliance and resource needs.
- Serves as a clinical representative for cross functional workstreams.
- Reviews and evaluates results of clinical trial data in preparation for new drug application to the regulatory agencies.
- Acts as a liaison between company and clinical investigators.
- Develops credible relationships with opinion leaders, medical directors, and key regulatory officials.
- Performs medical monitoring/reporting, evaluates ongoing clinical trial data.
- Manages and provides oversight on trial results;
- Assists with development of clinical research protocols, study case report forms, informed consent and drug projections;
- Organizes documentation needed for data collection, analysis;
- Reviews and maintains correct standard operations, procedures and protocol;
- Can interpret results of clinical trial data in preparing new drug applications to the appropriate governmental body;
- Guides and mentors less experienced team members in adherence to clinical research guidelines and safety procedures;
- Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies;
- Crafts essential conditions that are necessary to determine the safety, efficacy, medical usefulness, and marketability of drug and product candidates;
- Communicates detailed outcomes and results of research findings to relevant partners;
- Provides input in managing project budgets and projections;
- Completes relevant registration, submissions and reports;
- Serves as liaison to clinical sites and other vendors, as well as internal/external customers;
- Presents research status at internal/external meetings, including investigator meetings and company sponsored events
- Assists with interactions with health authorities
- Bachelor’s degree required. An advanced degree (MS, MSN, RN, PharmD, PhD) preferred.
- A minimum of 6 years of progressively responsible experience in clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.
- Experience in oncology therapeutic area is required.
- Significant experience with clinical trials including development of protocols, case report forms, informed consent, study initiation, protocol training, and clinical data monitoring required.
- Excellent written communication, oral communication, and presentation skills are required.
- The individual must have demonstrated ability to work and lead in a cross-functional team environment and be flexible and adaptable.
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Glasgow, Scotland, UK
Application Deadline: N/A