Company

On Target Laboratories, Inc. discovers and develops targeted intra-operative imaging agents which illuminate malignant lesions and other diseased tissue. These imaging agents can be used by surgeons to help identify additional cancerous lesions and more precisely guide surgical oncologic procedures across a broad range of cancer types, thereby improving cancer surgery by helping to reduce the risk of recurrence and surgical complications for patients.

Responsibilities

Reporting to VP Clinical, the Sr. CTM is responsible for the planning and management of clinical studies and GCP related activities for several studies and indications simultaneously. Assignments may include protocol development, study management, SOP development, supervision of vendors, and case support.

Summary of Essential Job Functions

• Independently perform or guide clinical activities consisting of multiple studies running simultaneously.
• Serve as a direct study manager on a portion of studies within a program, fulfilling all associated duties.
• Oversee activities of full-time and contract CRAs for assigned studies; interact with CROs, provide guidance to CRO personnel and negotiate sponsor/CRO relationships if appropriate.
• Responsible for managing the conduct of single and multi-center studies globally and study activities such as study design, protocol preparation, investigator selection, investigator meeting, budget and contract preparation, negotiate final budgets with investigators and/or institutions, and development of monitoring/communication/enrollment plans.
• Review and approve monitoring visit reports, regulatory documents, and other key study records.
• Develop systems for the tracking of projects, including site information, IRB/IEC information, study progress, subject recruitment activities, and other clinical trial materials, as needed.
• Contribute to authorship of study protocol(s) and coordination of clinical activities across all assigned studies.
• Assist in the preparation of Case Report Forms, monitoring and data management tools and other study documents.
• Represent Clinical Operations on cross-functional project teams.
• Oversee clinical processes to ensure timelines are met.
• Organize, oversee and implement protocol training and other supportive activities at Investigator meetings.
• Provide input related to the preparation of Investigational New Drug (IND) Applications, Sponsor’s Clinical Reports, Annual Progress
• Reports, manuscripts and regulatory submissions related to clinical content.
• Actively participate in project and strategic planning.
• Maintain expertise in relevant areas of government and industry regulations and clinical science and apply knowledge by leading the development of cross-functional process improvement activities and training program.
• Identify and manage contract monitors and contract research organizations.
• Identify and manage other vendors such as central labs, interactive voice response providers, recruitment services, meeting planners, clinical supply services, etc. as needed to meet study objectives.
• Provide recommendations regarding monitoring safety, eligibility, enrollment and data consistency for assigned studies.

Qualifications

• Bachelor’s Degree from an accredited College or University in pharmacy, biological sciences, chemistry, or other appropriate scientific/technical discipline with a minimum of 7 years of clinical research experience, at least 2 years in a study management role
• Or a Masters or Doctoral Degree (e.g. PhD, PharmD) from an accredited College or University in pharmacy, biological sciences, chemistry, or other appropriate scientific/technical discipline with a minimum of 5 years of applicable clinical research experience.
• Current knowledge of global GCP guidelines and regulations is essential. This job requires a broad knowledge of the global clinical research and drug development process.
• Capable of formulating a clinical project plan based upon literature, input from internal and external experts, and own experience.
• Must have a demonstrated ability to guide programs having major division/staff importance to successful completion with minimal direction.
• Ability to manage vendor/contracts relationships.
• Must be able to travel up to 50-75%, domestic and international.
• Ability to provide operating room case support, including credentialing with multiple credentialing vendors
• Must have demonstrated the ability to interact with peers and senior staff members and maintain good interpersonal working relationships.
• Strategic thinking and strong decision-making capability.

On Target Laboratories, Inc. is an Equal Opportunity Employer. On Target Laboratories, Inc. does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non- disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

WHO WE ARE

Our vision at On Target Laboratories is to brighten the future for those fighting cancer by making cancer visible intraoperatively so it can be removed more completely with our cancer-targeted intraoperative molecular imaging agents.

We are an agile, tenacious, collaborative biotechnology start-up with a relentless focus on advancing real- time cancer imaging. Our end game is helping people fight cancer, boldly pushing boundaries to advance science, technology, and humanity.

Our intraoperative molecular imaging agents, based on the pioneering work of Purdue University’s Philip S. Low, PhD, illuminate cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

CYTALUX (pafolacianine) injection, On Target’s first product, received FDA approval for ovarian cancer in November 2021 and lung cancer in December 2022. For more information visit www.ontargetlabs.com and www.cytalux.com.

WHAT YOU WILL DO

As the Quality Assurance Supervisor you will play a significant role in ensuring the On Target’s products and processes meet FDA regulations and related industry standards. You will formulate and supervise the quality processes within a commercial pharmaceutical organization.

This is a remote based position with at minimum quarterly company-wide meetings either at the On Target headquarters in West LaFayette, Indiana or a location as identified by Executive Management.

The ideal candidate would be located in either the Central or Eastern time zones.

This position has no direct reports.

PRIMARY RESPONSIBILITIES

• Develop/improve, implement, and maintain the quality management system (QMS) to comply with FDA, applicable international, and related industry guidelines.
• Stay up-to-date with evolving quality assurance requirements and industry best practices, ensuring the organization’s compliance.
• Assist in the development, compilation, review, and approval of other quality-related documentation, such as standard operating procedures, product quality complaints, annual product quality reviews, analytical test methods, validation protocols and reports (equipment, process, analytical method), risk assessments, quality and technical agreements, etc.
• Provide training and mentorship to team members, ensuring they are adequately trained and knowledgeable in regulatory requirements, quality principles, and internal policies and procedures.
• Undertake the review, investigation (as appropriate), and approval of (pre- and post-execution) batch records including associated supporting documentation, such as deviations, out of specification results, change controls, corrective and preventive actions, and quality control test results.
• Oversee the evaluation and management of suppliers to ensure the quality of products or services provided by GxP suppliers.
  • Conduct supplier audits to assess compliance with quality standards, identify areas for improvement, and ensure adherence to procedures.
• Generate reports on quality performance metrics.
• Work with Clinical Operations to develop and implement clinical quality risk management strategies for investigator sites suppliers, clinical documentation and systems ensuring compliance with Good Clinical Practices (GCP).
• Collaborate with other departments, such as CMC, Clinical, Research and Development, and Regulatory Affairs, to ensure consistent quality across all aspects of the product lifecycle.
• Drive Quality Improvements: Identify and resolve quality issues and lead initiatives for continuous improvement.
• Monitor and Report Quality Metrics: Track key quality indicators and share insights with executive leadership to support ongoing improvement efforts.

QUALIFICATIONS & SKILLS

• Bachelor’s degree in a scientific field (e.g., biology, chemistry).
• Minimum 4 to 6 years’ experience in pharmaceutical manufacturing and quality assurance.
• Strong knowledge of FDA regulations and other relevant quality and related industry standards.
• Experience in sterile manufactured products preferred with small molecules being ideal.
• Excellent communication, and interpersonal skills.
• Strong analytical and problem-solving skills.
• Proficiency in quality management systems and data analysis tools.
• Exposure to Regulatory Affairs or an interest in learning the Regulatory Affairs role is a plus.

On Target Laboratories, Inc. is an Equal Opportunity Employer. On Target Laboratories, Inc. does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non- disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.