Associate Director/Director, Clinical Scientist
Posted on Jun 20, 2021 by SQZ Biotechnologies
SQZ Biotechnologies is seeking a Clinical Scientist who is inspired to improve treatment for patients with cancer and other diseases with innovative cell therapy approaches. We expect significant growth of our clinical trial activities and this is an opportunity to directly impact our patients. Reporting to the Senior Director, Clinical Development, the Clinical Scientist will help with day-to-day aspects of SQZ clinical drug development programs in support of the implementation and execution of our medical strategy. This includes working cross-functionally to assure the highest standards of clinical drug development and GCP.
Works closely with Medical Directors, Clinical Operations, Research, Exploratory Biology, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
Oversight of medical aspects of regulatory or communications documents
Medical review of clinical trial data
Collect external data and review like competitive intelligence
Assists Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts
Drives the clinical contribution to annual update of IB liaising with Translational Medicine, Safety, Regulatory and Medical & Communication Experts
Drives and integrates clinical contribution to answering regulatory queries and other submissions related to studies
Monitors Real Time study data to ensure the integrity of the study and the study data and interacts with investigators and internal and external experts to resolve any study issues as they arise
Involved in high level data cleaning activities requiring clinical judgment and in analysis of complex data for regulatory submissions, publications and design of studies and programs
Works with investigative sites to answer protocol related questions, resolve study conduct and design issues
May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
Supervision of external consultants if applicable
PhD and/or MS, PharmD, BSN in relevant scientific field; with experience in pharmaceutical and/or biotech industry.
Strong interpersonal, organization, planning and communication (oral and written) skills.
Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP guidelines
Ideally, experience in both early and late phase development
Medical knowledge and experience in clinical development/operations (Oncology preferred)
6+ years in the biopharmaceutical industry with experience reviewing clinical data.
Ability to perform literature searches, to utilize library services and to conduct basic data analyses using Excel and other tools
Basic understanding of biostatistics to allow effective interaction with biostatistics expert
Ability to drive decision-making within a multi-disciplinary, multi-regional Matrix team
Diplomacy and positive influencing abilities
Experience building data presentation plans
Team player and an entrepreneurial and hands-on attitude and highly self-motivated.