Council of State and Territorial Epidemiologists

Associate Director / Director, Clinical Scientist

SQZ Biotech
Watertown, Massachusetts, United States
8 days ago

Description

Associate Director / Director, Clinical Scientist

Our Purpose: Empower Cells to Change Lives 

At SQZ Biotechnologies (NYSE: SQZ) we believe that our cell therapies will revolutionize the way we treat diseases. Our unique capabilities enable us to engineer almost any function into any cell type, breaking down the barriers in the field, and creating the possibility for cell therapies that could not have been previously envisioned.

Our Values: 

  • Patients are the Purpose: We strive to transform patient quality of life so they can focus on living.
  • Squeeze Together: We are one team with one goal. Only through the sum of our strengths can we achieve our shared purpose.
  • Own the Outcome: We are what we do. Integrity and accountability are fundamental.
  • Challenge the Now: We fearlessly drive innovation by questioning what is possible, fostering creativity, and executing on our ideas.

The Role:

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.   

Key Responsibilities:

  • 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 

Qualifications:

  • 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. 

SQZ Biotechnologies is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, SQZ complies with applicable state and local laws governing nondiscrimination in employment.



Job Information

  • Job ID: 58745567
  • Location:
    Watertown, Massachusetts, United States
  • Position Title: Associate Director / Director, Clinical Scientist
  • Company Name: SQZ Biotech
  • Job Function: Research,
    Scientist
  • Job Duration: Indefinite
  • Min Education: Master's Degree
Biotechnology
Watertown , MA , US

SQZ Biotechnologies is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies to benefit patients with cancer, autoimmune and infectious diseases. The company’s proprietary Cell Squeeze® technology offers the unique ability to deliver multiple biological materials into many patient cell types to engineer what we believe can be a broad range of potential therapeutics. Our goal is to create well-tolerated cell therapies that can provide therapeutic benefit for patients and improve the ...

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