Sr. Clinical Trial Manager, Melanoma | BioNJ Talent Services

Sr. Clinical Trial Manager, Melanoma

Contact Information
Contact Name: 
Sara Bonstein
Organization Name: 
Oncosec Immunotherapies
Position Location: 
Pennington, NJ
Email to Apply: 
sbonstein@oncosec.com
Company Profile: 

OncoSec Medical Incorporated is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies with new technologies to stimulate the body’s immune system to target and attack cancer. Through our proprietary technology we hope to deliver safer and more effective cancer treatments that can provide long-term benefits for patients. Our investigational platform, Intratumoral IL-12, is designed to enhance local delivery and uptake of DNA-based therapeutics directly into tumors. Clinical studies of Intratumoral IL-12 with plasmid encoded IL-12 (tavokinogene telseplasmid or “TAVO”) demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach. Currently, we are conducting pre-clinical and clinical studies targeting various cancers in collaboration with several prominent academic medical centers and companies. To date, study results have laid the groundwork for OncoSec’s expansion into new DNA-encoded therapeutic candidates and tumor indications. These results allow us to explore the broad applications of our proprietary technology and pursue combination therapies that address a great unmet medical need in oncology: anti-PD-1 non-responders.

Job Description:

JOB SUMMARY:
Responsible for the operational management of OncoSec’s clinical trials either directly or through Clinical Research Organizations (CROs). Ensures clinical trial activities and deliverables are completed on-time and within budget. Manages various stages of multiple clinical trial studies within the organization, providing appropriate level of oversight for each study. This position would travel ~25% of the time. Located in Pennington NJ, with a partial work from home possible upon request/need. Experience in oncology is a must, while experience in melanoma a plus
ESSENTIAL JOB DUTIES/RESPONSIBILITIES:
• Manages and leads the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Manages and leads cross-functional study teams, including vendors and CROs; liaises with other functional areas in order to accurately coordinate clinical study activities.
• Coordinates clinical study timelines with Operations management to meet critical milestones; escalates issues that may jeopardize timelines and deliverables.
• Conducts study monitoring visits and co-monitoring visits as needed.
• Provides regular updates of study progression to management; proactively identifies and resolves issues that arise during study conduct; manages escalation of study-related issues.
• Leads development of study plans and system set-up; participates in preparation and ensures operational excellence of protocol, CRF, CSR and other key study team deliverables.
• Implements appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
• Supports preparation of vendor requirements and project scope and selection of study vendors; effectively manages interactions with vendor study teams.
• Supports feasibility assessments and selection of countries and sites for study conduct.
• Oversees the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participates in data reviews and review of statistical analysis plans.
• Authors, audits and/or edits written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals).
• Ensures set-up and implementation of effective investigator and site monitor training; coordinates operational and therapeutic area training for internal and external study team members.
• Provides oversight and direction to study team members, including vendors, for study deliverables.
• Supports coordination with Finance to track the financial status of studies against budget.
• Other duties as assigned.

Qualifications: 

EDUCATION/EXPERIENCE/SKILLS:
• Bachelor’s degree in life sciences or other field related to human study. An equivalent combination of education and applicable job experience may be considered.
• Minimum of 5 years’ experience in a combination of the following:
 Minimal of 2 years of global trial or project management experience
 Experience as a Clinical Research Associate (CRA)within an FDA or other agency regulated organization
 Experience in the pharmaceutical/biotech or medical device industry
 Experience in oncology desirable.
 Experience with application of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
 Experience with all aspects of clinical trials including on-site monitoring experience.
 Experience in management of CROs and other vendors
Must possess:
• Excellent working knowledge of all applicable ICH/GCP regulations and CFR guidelines
• Leadership study ability
• Ability to “roll up your sleeves” and individually contribute results to a research and development effort
• Excellent time management, project management, organizational, and communication skills (written and verbal) in English
• Expertise in and excellent working knowledge of core systems and tools
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or participating as an individual contributor
• Computer literacy mandatory with proficiency in Microsoft Word, Excel, Project and Outlook.
• Ability to coordinate and plan budgets and people utilizing time management skills
• Ability to recognize potential obstacles and work to resolve them within set timelines
• Conscientious and precise delivery of work even when under pressure
• Ability to travel up to 25%
JOB SCOPE:
Provides guidance to subordinates and/or manages department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

ADA REQUIREMENTS:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. In a lab setting, occasionally use hands to finger, handle objects, tools, or controls. Employee must occasionally lift and/or move up to 20 pounds. May require travel up to 25%.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Clinical Trials