Sage Therapeutics

Associate Director, Clinical Operations & Development

US-MA-Cambridge
2 weeks ago
ID
2017-1397
# of Openings
1
Category
Clinical

Overview

General Scope and Summary

 

The Associate Director, Clinical Operations and Development will oversee clinical development programs (pre-IND through Phase 1-3 clinical trials) in the field of neurology and CNS disorders. This key role will manage, plan, and execute clinical development programs and studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s). 

 

Roles and Responsibilities

  • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
  • Create, manage, and execute clinical operations and development programs, including study management, and budget and timeline creation
  • Ability to build strong KOL and Principal Investigator relationships, with the ability to easily understand and explain complex scientific topics
  • Lead program development teams, and understand the intricacies among the different cross-functional groups
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
  • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
  • Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
  • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
  • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
  • Attend scientific conferences as needed

Experience, Education and Specialized Knowledge and Skills

  • Master’s degree preferred in a scientific or healthcare discipline
  • Minimum of 8 years in clinical and drug development in the pharmaceutical/biotech industry (5+ years of study or program management)
  • Understanding of drug development and program management from pre-IND through NDA is essential
  • Extensive experience managing clinical programs, CROs, budgets, and timelines required
  • Strong working knowledge of MS Project and developing Gantt charts
  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
  • Management of CROs, multiple vendors, and complex protocols
  • Protocol, ICF, and CSR writing experience required
  • A detailed understanding of overall strategic direction, interrelationships and business needs
  • Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered
  • Proven experience in the oversight of the operational aspects of all stages of clinical studies
  • Ability to organize and manage multiple priorities required
  • Excellent oral, written, and medical communication skills required
  • Ability and willingness to travel up to 25% of the time, as needed

Attributes

  • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Proactive and positive management approach
  • Maximum flexibility to adapt to changing program needs in real time
  • Strong leadership skills
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Excitement about the vision and mission of Sage

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