<p>Working within a matrixed environment, the Senior Clinical Scientist will be a cross-functional influencer in the maturation of the global product development plan, including the clinical development plan, clinical trial design, study protocol, and clinical study execution. The Senior Clinical Scientist will be fully conversant with the fundamental stages and principles of drug development, the principles of pharmacologic action, the design and execution of well-controlled clinical trials, and the fulfillment of regulatory requirements while observing Good Clinical Practice (GCP); and will apply this expertise within a matrixed clinical research and development setting, to include the following: Work with the Therapeutic Area Head as well as Medical Director(s), to create key strategic documents, including the clinical development plan, protocol concept and full protocol for one or more products in early stage development, while also contributing to product(s) in later stages of development, including NDA filings Contribute to the key documents describing products in development, such as the Investigators' Brochure and safety updates Contribute to correspondence with the health authorities approached by the assigned programs, such as the briefing book, IND, NDA, as well as responses to health authority questions Develop a working knowledge of the operational characteristics of the clinical endpoints relevant to the assigned clinical trial indication, the study population represented by various inclusion/exclusion criteria or diagnoses, and their use in previous clinical trials, to enable informed and innovative clinical trial design Develop a working knowledge of the clinical scales and patient reported outcome tools associated with the assigned clinical trial indication in order to facilitate their qualification and justification for regulatory correspondence and study start up activities Develop a working knowledge of the biomarkers and other measured endpoints associated with the assigned clinical programs, their assay characteristics, sample handling requirements, and qualification needs, if any Monitor regulatory policies and guidance to ensure scientific quality/innovation of clinical study design, execution, reporting and publication Ensure that all studies observe the highest standards of ethical and safe conduct, and ensure compliance with GCP; monitor study progress and perform medical data review to ensure integrity of study data and appropriate safety follow-up Plan and participate in investigators meetings and protocol training meetings Develop effective working relationships with investigators in assigned programs Prepare and run dose escalation meetings with investigators (phase 1) Lead or contribute to trial-related advisory boards Assist in forecasting trial resource needs Analyze and interpret study data from an individual study; translate study level clinical data across the program of studies for a particular drug Facilitate the awareness of the real-time availability of clinical trial data (including safety, efficacy, pharmacokinetic and biomarker data), to provide consolidated information for dose escalation meetings, data safety monitoring boards, and interim analyses Set up and manage investigator initiated clinical and/or pre-clinical trials Assist Clinical Operations in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties Master's Degree, PhD, PharmD, or M.D. preferably with a clinical research background, or clinical trial/drug development experiences at various phases of development (Phase 1-3) Industry experience (3+ years) in R&D preferably focused on rare diseases Working knowledge of the concepts of global clinical development, clinical research, and clinical trial design, including biostatistics, dose selection, clinical endpoint validation, product profiles and target labels, and global regulatory agency processes Professional history of solving problems and navigating uncertainty while exhibiting superior judgement and a balanced, realistic understanding of competing issues and priorities Professional history that includes a track record of collaboration skill in working within a matrix environment Professional history that includes a successful track record of preparing and conveying complex medical/clinical concepts in both written and oral communication Professional history that demonstates scientific and analytic ability, ability to think strategically and tactically, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize Professional history that demonstrates the ability to initiate and cultivate productive relationships with investigators, scientists, and patient advocates</p>