Associate Director, Clinical Scientist

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Associate Director, Clinical Scientist

The Associate Director, Clinical Scientist will contribute in all areas of one or multiple clinical projects including, but not limited to, study planning, protocol development, study clinical oversight, data review, interpretation and documentation.

The Associate Director, Clinical Scientist will collaborate with Clinical (MD) Leads, Clinical Operations, Regulatory, Research and other functions within AVROBIO. The. Clinical Scientist will have a substantial role in protocol development, study execution, review and interpretation of scientific and clinical data and communication with the scientific and medical communities.

Cambridge
Research and Development
Jun 1 2021
Key Responsibilities
  • Support Clinical Development Lead/Study Physician on all trial related education for sites, staff, vendors and other functions
  • Support the development of a Clinical Development Plan
  • Perform ongoing review and analysis of study data for ongoing clinical trials
  • Provide support as needed for scientific issues that may arise during study execution
  • Provide strategic and planning support for publication of data and collaborate with other functions and assist in the preparation of abstracts, publications, posters and oral communications for scientific meetings
  • Identify and review literature that addresses specific topics of interest relevant to AVROBIO candidates
  • Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature
  • Support document development, such as the investigator brochure, clinical protocols, statistical analysis plans, clinical study reports, competitive assessments, etc.
  • Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied
  • Systematically survey public domain for relevant information from competition, summarize clinical trial designs and data for similar drug products, review and summarize Summary Basis of Approval documents for competitive compounds
  • Contribute to the organization, preparation, and execution of investigator and advisory board , steering Committee, DMC, etc in collaboration with the project team and external vendors
  • Support preparation of scientific material for conference presentations or publications
  • Collaborate with cross-functional groups for assigned studies
  • Perform other duties as assigned related to clinical programs
  • Ensure compliance with GCP, Clinical Operating Guidelines and Standard Operating Procedures
  • Liaise and communicate with other functions including operations, biometrics, safety, regulatory affairs and medical affairs to coordinate the clinical efforts on project related issues.
  • Contribute to the preparation of all clinical trial documents submitted to regulatory authorities and ethics committees/IRBs.
  • Accountable for data interpretation and appropriate content of interim and Final Study Reports for approval to internal governing entities, and assist in authoring these
Minimum Requirements/ Qualifications
  • Advanced, doctoral level degree preferred. PhD, MD, MSc/MPH, PharmD, with 5+ years of experience within a pharmaceutical company environment required
  • Gene therapy and rare disease experience preferred
  • Excellent management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
  • Passionate commitment, detail-oriented and a strong team player
  • Ability to work independently and reliably deliver objectives of high quality in a timely manner
  • Experience in all stages of drug development
  • Strong Global clinical research experience and working as part of a cross functional clinical team
  • In-depth knowledge of the regulatory path across the various health authorities (FDA, EMA, PMDA, etc)
  • Demonstrated ability to quickly understand and apply scientific concepts in a clinical setting.
  • Able to evaluate, interpret and synthesize scientific data, and verbally present and critically discuss clinical trial data in internal and external meetings
  • Excellent verbal and written communication skills
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer