• SQZ Biotechnologies
  • $82,910.00 -167,060.00/year*
  • Watertown , MA
  • Executive Management
  • Full-Time
  • 2 Barnard Ave

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At SQZ Biotechnologies 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: * Squeeze Together: We value teamwork, trust, and transparency as critical components for achieving our mission and exceeding our goals * Question Boundaries: We're committed to questioning the status quo and changing the world through our people and our science * Zap Obstacles: We strive to be pioneers. We're resilient when it comes to navigating challenges, anticipated or not, scientific and otherwise

SQZ Biotechnologies
Sr./Director, Clinical Development (Clinical Scientist)
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Description
Sr./Director, Clinical Development (Clinical Scientist)
Our Purpose:
EMPOWER CELLS TO CHANGE LIVES
At SQZ Biotechnologies 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:
* Squeeze Together: We value teamwork, trust, and transparency as critical components for achieving our mission and exceeding our goals
* Question Boundaries: We're committed to questioning the status quo and changing the world through our people and our science
* Zap Obstacles: We strive to be pioneers. We're resilient when it comes to navigating challenges, anticipated or not, scientific and otherwise
The Role:
SQZ Biotherapies is inspired to improve treatment for patients with cancer by innovative cell therapy approaches. We expect significant growth of our clinical trial activities over the next 2 years. At our current stage, the Senior Director, Clinical Development is responsible for all day-to-day aspects of SQZ Biotherapies' clinical drug development programs in support of the implementation and execution of our medical strategy. He or she will work in cross-functional teams to assure the highest standards of clinical drug development and GCP.
* Responsible for medical aspects of regulatory or communications documents
* Responsible for medical review of clinical trial data
* Responsible for external data collection and review like competitive intelligence
Responsibilities:
* Works closely with CMO or Medical Directors (as the function grows), Research, Exploratory Biology, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
* 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
* Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
* Acts as clinical/scientific expert on the products and studies in the therapy area
* Attends scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
* 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
* Support of Strategic or Clinical Advisory Boards
* Supervision of external consultants if applicable
* Internal resource for all SQZ functions requiring clinical input
* Primary point of contact for clinical trial staff at study sites
* Together with Clinical Operations preparation of Investigator Alert letters and SAE reports as required
* Medical Affairs activities as needed
Candidate Must:
* Team player and an entrepreneurial and hands-on attitude and highly self-motivated.
* Diplomacy and positive influencing abilities
* Strong interpersonal, organization, planning and communication (oral and written) skills.
Minimum Qualifications:
* Director: MS in Life Sciences and 8 years of experience or BS in Life Sciences and 10 years; Sr. Director: MS in Life Sciences and 10 years of experience or BS in Life Sciences and 12 years; other equivalent clinical qualifications with experience in a major pharmaceutical and/or biotech company.
* 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)
* 8+ 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
* Experience building data presentation plans
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. SQZ does not support relocation for this role.
Job Information
* Location: WATERTOWN, Massachusetts, 02472, United States
* Job ID: 48297801
* Posted: May 7, 2019
* Position Title: Sr./Director, Clinical Development (Clinical Scientist)
* Company Name: SQZ Biotechnologies
* Job Function: Clinical,
Scientist
* Entry Level: No
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* Team player and an entrepreneurial and hands-on attitude and highly self-motivated. * Diplomacy and positive influencing abilities * Strong interpersonal, organization, planning and communication (oral and written) skills., * Director: MS in Life Sciences and 8 years of experience or BS in Life Sciences and 10 years; Sr. Director: MS in Life Sciences and 10 years of experience or BS in Life Sciences and 12 years; other equivalent clinical qualifications with experience in a major pharmaceutical and/or biotech company. * 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) * 8+ 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 * Experience building data presentation plans


Associated topics: administrative, assistant, asso, beverage, document, facilities, operational assistant, operational support, operations director, records management

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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