Clinical Project Scientist

Clinical Project Scientist - 6 month - 1 year project with possibility of extension

The Associate Director, Clinical Project Scientist (CPS) acts, in collaboration with NS Medical Affairs leadership to connect therapeutic strategy and the clinical and operational implementation of company-sponsored or investigator-initiated studies conducted through in-sourced, out-sourced or matrixed organizations. The CPS manages project management activities in Phase IIIb - Phase IV clinical trials including Medical-Affairs database analyses, investigator-initiated studies, scientific communications/publications, and research-related activities to ensure timely and compliant execution. The CPS also participates in protocol development, study follow-up during conduction and interpretation of results, and preparation of scientific communications.

Key Responsibilities:

• Responsible for operational oversight of clinical trials, non-interventional research activities, post-marketing research programs, and other activities such as steering committees, data safety monitoring boards, and investigator meetings.
• Provides operational oversight and active contributions to the planning and development of protocols, projects, and other research-related activities. Handles JJAR and ReCAP entries and close-out.
• Provides review of medical publications, commercial materials, and clinical study reports.
• Supports development and management of clinical studies, database analyses and preparation of oral and written communications for internal and external presentations, FDA or health authority submissions and external review bodies. Responsible for management of adverse event data collection for PSUR, PADER and other annual regulatory obligations. Partners with Global Medical Safety and other safety personnel.
• Co-manages and is accountable for financial budgets and contract development for the therapeutic area, and acts as a primary liaison with Director of Department Strategic Operations.
• Strategically aligns and partners with individuals and groups within and outside of department (e.g., GCSO, LSO/GMS, GMA, Regulatory Affairs, QA, Health Care Compliance, Privacy, and the Law Department) around requirements related to research programs and operations, ensures compliance with vendor training requirements, and assists in audits.

Qualifications

Education:

• BA/BS in Science or Healthcare required; MS, MPH, RPh, PharmD, or PhD in Science, Pharmacy or Healthcare preferred

Experience and Skills:

Required:

• Minimum of a bachelor’s degree is required; an advanced degree in healthcare or neuroscience is preferred.
• Neuroscience therapeutic area experience conducting clinical trials
• Minimum of 7 years of experience within the pharmaceutical industry is required, with experience in managing Phase IIIB - IV clinical trial programs and other research activities.
• Must possess technical proficiency, and strong problem-solving skills.
• Strong leadership, interpersonal, partnership, and oral/written communication skills are required.
• Ability to operate in a matrixed environment and experience with cross-functional alliances is required
• Able to think creatively, critically, and proactively, understand diverse viewpoints and partner needs, develop mutually agreeable solutions, and see them through to conclusion at the highest ethical standard.
• Strong work ethic, integrity, and ability to efficiently balance multiple priorities

Preferred:

• Direct experience with operational management of a clinical trial, files in SharePoint, or similar systems
• Ability to collaborate with in-sourced and out-sourced trial execution resources, and with the GCO organization.
• Experience supporting clinical strategy, and goals & objectives within a therapeutic area
• Ability to develop and maintain focus in a changing environment

Other:

Able to travel, including internationally (up to 15% of the time or more); includes travel by air, domestic and international, up to 15% or occasionally more, including overnight and weekends.