Clinical Scientist

Role Summary

The Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects’ data in these studies. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology, Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs.

Responsibilities

• Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings.
• Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations.
• Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) for discussion with the clinical team.
• Perform regular trend analysis in ongoing clinical trials.
• Lead periodic Medical Review meetings.
• Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings.
• Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions.
• Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents.
• Collaborate in cross-functional meetings to develop clinical development plans.
• Support Clinical Operations, CROs, and site staff on study protocol related questions.
• Support preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations.
• Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates.
• Participate in research site identification and relationship building with CROs in this space.
• Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions).
• Other duties as assigned.

Qualifications

• MD, Ph.D., Pharm. D., MPH, MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company.
• Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
• Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters).
• Great analytical skills and a passion for ‚Äúsearch and find‚Äù among complex data generated in clinical studies.
• Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization.
• Ability to thrive in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, flexible and decisive.
• Ability to inspire and earn respect from the leadership team, colleagues, and staff; respectful of the ideas and experience of all members of the team.
• Ethical, with high integrity; commitment to patient care and responsible stewardship of resources.
• Desire to develop personal and communication skills through complex tasks and challenges.

Physical Demands

• On a continuous basis, sit at a desk for long periods; may require lifting up to 25 lbs; walking occasionally; moderate noise level.
• Laboratory activities may be applicable; biology and chemical laboratory environment experience may be needed.

Travel

You may be required to travel up to 5% of your time.