Akebia Therapeutics, Inc. Cambridge , MA 02138
The Scientific Director, Clinical Development will primarily be responsible for the execution, presentation, and coordination of data analysis as part of medical and clinical monitoring. The Director will function as the technical expert on assigned studies and programs driving the scientific aspects of study design, data review and interpretation, program planning, data presentation, and data integration. The Director may also provide oversight of vendors and services to support literature searches, medical writing, and other unique analytical or scientific services. The Director will work closely with stakeholders providing scientific expertise and building effective relationships with other functional lines within Akebia to ensure the optimal planning, execution and interpretation of clinical trials.
This individual will interface directly with other functions including Clinical Operations, Data Management, Strategic Project Management, Regulatory, Drug Safety/Pharmacovigilance, Medical Affairs, Medical Writing, Regulatory Affairs, Research, and Toxicology.
Responsible for coordination and oversight of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
The Director coordinates with functional group leadership (Clinical Operations, Medical Affairs, Regulatory, Drug Safety Pharmacovigilance (DSPV), Early Stage Commercialization (ESC), Chemistry, Manufacturing & Control (CMC), pre-clinical research, project management and Finance) and external partners to assure progress and timely completion of program(s) and/or department goals.
Effectively communicate (oral and/or written) program-related information to Clinical Development management, Clinical Operations management, project management and integrated oversight teams.
Complies with FDA regulations and Good Clinical Practice (GCP) guidelines and SOP's for clinical studies.
Provides strategic input and negotiates resource requirements to use in establishing clinical milestones and timelines to Clinical Program Teams. Works with Clinical Project Management to identify key tasks, milestones and resourcing for individual programs.
Support scientific aspects of study data capture, review and final presentation, including providing scientific review to eCRFs, edit checks, line listings, queries, and driving resolution of scientific issues as they arise.
Support activities necessary to conduct interim analyses or blinded data reviews that are delegated to independent committee or statisticians.
Lead or participate in sub-teams involved in continuous improvement and corporate initiative activities as appropriate.
Draft Clinical Research Standard Operating Procedures and Policies for Clinical Development related activiti
Provide clinical development and technical expertise in support of due diligence activities.
Assist in the identification and selection of external experts and clinical consultants.
Create relationships with key external experts (EE's) to obtain medical and scientific input for clinical development
Advanced degree: Masters, PhD or PharmD.
Minimum of 10 years' experience working in biotech/pharmaceutical industry; preferably in clinical research group with a strong knowledge of drug development
Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, MS Project and analytical skills.
Ability to work collaboratively in a fast-paced, team-based matrix environment
High level of organizational, prioritization and project management skills
Flexible to accommodate changes in team and project needs.
A comprehensive understanding of the drug development process in all phases of testing, contributing to the clinical strategy and creation of the clinical development plans while working as part of an integrated team.
Ability to identify and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.
Experience in providing support to advisory boards, consultant meetings and investigator meetings (including preparation and delivery of presentations)
Collaborate with the clinical development team on the review, analysis, and interpretation of study results.
A thorough understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (clinical ops, reg, QA) and clinical investigators.
Job Location Cambridge, Massachusetts, United StatesPosition TypeFull-Time/Regular