Sr. Director, Clinical Science, Mitochondrial Disorders

Location: Emeryville, CA
Department: Clinical Development - MDS

POSITION SUMMARY

We are seeking an experienced Senior Director, Clinical Science – Mitochondrial Disorders. The ideal candidate will be an innovative, strategic thinker who will implement clinical development strategies and have strong experience with clinical study conduct, data analysis, and health authority document preparation and interactions. The individual should have excellent leadership, communication and multi-tasking skills.

Responsibilities

  • Work closely with the Executive Medical Director, Mitochondrial Disorders and assist in leadership, oversight and management of clinical studies including planning, execution, completion and reporting of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs.
  • Review and analyze clinical data and assist in generating study reports, publications and regulatory documents.
  • Communicate, interface, coordinate, and provide ongoing assessment, and evaluation with other functional areas such as Regulatory and Clinical Operations, and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are met efficiently and on time in accordance with applicable regulations and guidance.
  • Assist in drafting of clinical and safety sections of regulatory documents.
  • Partner with Clinical Operations in leadership of clinical study teams and serve as study medical monitor to include ongoing evaluation of safety and efficacy trends/metrics.
  • Identify and manage clinical study level risks in collaboration with clinical study team.  Proactively communicate potential risk impacts and resolutions with Head of Clinical Development and Program Lead.
  • Represent Clinical Science in generation of content and strategy in support of health authority activities like, MAA filing and EMA interactions.
  • Identify and assist in managing external collaborators, investigators, key clinical academic experts and consultants.
  • Provide management personnel with timely updates on progress and proposed changes in scope, schedule, and resources as required.
  • Ensure compliance with GCP and all applicable regulatory standards related to global clinical trials and interactions with physicians.
  • Develop and maintain professional relationships with external stakeholders such as key opinion leaders.
  • Other duties as assigned. 

Job Qualifications

  • MD or PhD with at least 5 years’ experience in clinical development, clinical trial design and execution, and analysis of data
  • Rare disease and/or neuromuscular disease and/or genetic disease experience preferred
  • Small company or start-up experience preferred
  • Experience with NDA/MAA filing highly desirable
  • Strong influence and negotiating skills and ability to think creatively and develop creative solutions
  • Knowledge of Good Clinical Practice (GCP), FDA and EMA regulations and guidelines
  • Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while acting with integrity and credibility to build trust
  • Ability to prioritize and handle multiple projects simultaneously
  • Sense of urgency and perseverance to achieve results
  • Ability to represent Modis programs and engage external business partners/KOLs and effectively communicate complex scientific concepts to broad audiences
  • Willingness to travel