Clinical Scientist, Director Clinical Development

Role Summary

The Clinical Scientist (CS), Director provides scientific expertise necessary to design and deliver clinical studies and is responsible for clinical activities of assigned program. This role partners closely with the disease area heads, clinical trial physician, and clinical lead, in developing the scientific and clinical strategy of assigned trials and/or programs. As part of the clinical development team, the CS will use methodological, analytical and scientific expertise to develop study designs in different phases of clinical development. The CS ensures the collection, analysis, review, and reporting of high-quality trial data in accordance with Clinical Development plans. The role requires a well—organized operationally focused individual with analytic skills and ability to deliver multiple tasks that can collaborate closely with cross-functional teams. The CS is a member of the study team and CDT.

Responsibilities

• Provide scientific expertise to the clinical studies (e.g. protocol, Key Results, Clinical Study Report)
• Leads, plans and executes study level activities for one or more trials with minimal supervision
• Support other clinical development activities (e.g. medical review and validation of clinical data, study risk assessment)
• Contribute to the Protocol concept sheet, final protocol and protocol amendments and the clinical study report for their study(ies)
• Contribute to the clinical part of regulatory documents for their projects: Common Technical Document for FDA & EMA submission, PMDA, CA, etc and answers to questions from health authorities
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, clinical development team, and Investigators
• Be the clinical reference in the Clinical Study team related to clinical data

Qualifications

• Advanced Degree required preferably in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred). Strong scientific background is required.
• A minimum of 5 years of experience in clinical development within pharmaceutical industry or CRO, specifically in clinical study design, data analysis, data review and interpretation is required.

Functional Knowledge

• Understanding of phase I-III drug development including knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development processes.
• Demonstrates knowledge and application of statistical analysis methodology and can identify data trends and interpret data effectively through the continuum of a study.
• Knowledge of Therapeutic Area (TA) preferred, with the capability to interpret, discuss and present trial or program level data.
• Maintain knowledge of the TA, disease state and potential drug effects

Job-Specific Competencies

• Excellent scientific communication skills, both verbal and in writing (English).
• Ability to communicate effectively with senior management and colleagues.
• Strong negotiation and conflict resolution skills.
• Strong presentation skills.
• Ability to work in a matrix organization environment.
• Highly self-motivated and proactive.
• Team player.

Travel

Travel for the role is expected to be less than 20%