Director, Clinical Outsourcing | BioNJ Talent Services

Director, Clinical Outsourcing

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:
The Director, Clinical Outsourcing supports coordination and management of external service providers and other outsourcing needs for current and future clinical trials. Responsibilities include CRO/vendor/consultant identification, RFPs, service provider selection, contract negotiations, budget management and service provider performance metrics. This role may also be asked to assist with outsourcing for the pre-clinical and technical operations area of the business. The Director, Clinical Outsourcing reports to the Chief Clinical Development Officer with dotted-line reporting to the Chief Financial Officer.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES:
• Provides support and expertise in developing effective clinical contractual agreements, budgets, proposals and actively manage clinical contractual obligations.
• Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external service provider relationships to enable advancement of clinical development programs.
• Negotiates final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers.
• Negotiates change orders and ensures service providers adhere to contract terms.
• Reviews invoices against vendor contracts to ensure accuracy and service completion.
• Generates Request for Information (RFIs), Request for Proposal (RFPs) and budget grids/trackers for clinical trials, and assist Clinical Operations Management with the service provider selection process including bid comparison analysis.
• Coordinates bid defenses and proposal review meetings.
• Contract lifecycle management.
• Assists Clinical Operations and Finance with month-end and budget/forecasting needs, such as accruals, project budgets, etc.
• Facilitates and executes supplier governance meetings and reviews.
• Measures and reports quarterly service provider performance using metrics and KPIs to ensure compliance against agreed upon expectations such as timeliness, cost and quality.
• Assists Clinical Operations Management with creating clinical trial budgeting models and what-if scenarios.
• Assist with the identification and implementation of clinical contracts systems or processes.
• Assist management with audits of contract and sourcing records to ensure accuracy and completeness.
• Assists in the development, improvement and implementation of processes and tools related to outsourcing activities including a database for identifying and maintaining current and potential service providers.
• Manages contract activities for multiple clinical development programs, completing site and vendor contracts accurately, consistently, and in a timely manner, including the transition of certain activities.
• Manages the contract negotiation process, especially in more complex, or high value contracts.
• Supports the day-to-day activities of multiple areas in complex clinical contracting processes.
• Supports and manages general and departmental ad hoc projects as required.

Qualifications: 

EDUCATION/EXPERIENCE/SKILLS:
• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered.
• 10 years of related experience in a Biotech or Pharmaceutical organization.
• Solid understanding of drug development and clinical operations
• Ability to prepare/negotiate external provider master service agreements, work/change orders, etc. and track for clinical operations.
• Must demonstrate an understanding of clinical site and vendor budgets and payment terms.
• Experience in RFI/RFP development, proposal evaluation, and contract and budget management.
• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook.
• Must be a self-starter who works with minimal supervision.
• Works effectively in a matrix cross-functional environment.
• Good business judgment and a strong understanding of the unique aspects of clinical financials.
• Must have the ability to interact with clinical teams, corporate finance, and IT to provide oversight of clinical payment management activities
• Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present budget information effectively.
• High sense of accountability/urgency. Preferred Qualifications
• Preferred experience in RFI/RFP development, proposal evaluation, preparation/negotiation of clinical contractual agreements, manage contract lifecycle and budget management for assigned clinical project/operations
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