Careers

KEY RESPONSIBILITIES

Leadership & Strategy:

• Lead and develop the Clinical QA team, providing guidance and oversight to ensure the highest standards of quality are maintained across all clinical trial operations.
• Develop and implement the QA strategy for the organization’s portfolio of oncology trials, aligning with company goals, regulatory requirements, and industry best practices.
• Collaborate with senior leadership to ensure the integration of clinical quality assurance into the overall clinical development strategy.

Clinical Trial Oversight:

• Oversee all QA aspects of ongoing oncology clinical trials, ensuring regulatory compliance and adherence to internal policies and procedures.
• Ensure appropriate quality management systems (QMS) are in place to monitor clinical trial activities, including monitoring, auditing, and vendor management.
• Provide direction on trial design and execution to ensure robust quality systems and continuous risk management throughout all phases of clinical development.

Regulatory Compliance & Auditing:

• Lead the internal and external auditing process, ensuring audits are conducted as per the relevant regulations (GCP, FDA, EMA, ICH).
• Manage audit schedules, corrective action plans (CAPAs), and monitor their implementation.
• Prepare and support regulatory inspections and interactions with health authorities (e.g., FDA, EMA) to ensure readiness and compliance during inspections.

Continuous Improvement & Risk Management:

• Establish and maintain systems for the identification, mitigation, and management of clinical trial risks related to quality, safety, and regulatory compliance.
• Develop and implement quality improvement initiatives to enhance the efficiency and effectiveness of clinical trial operations and to reduce quality risks.
• Foster a culture of continuous improvement in clinical QA processes, ensuring lessons learned from trials are incorporated into future study designs and processes.

Collaboration & Communication:

• Collaborate with clinical operations, regulatory affairs, and other cross-functional teams to ensure alignment on quality objectives and seamless execution of clinical trials.
• Serve as the point of contact for all quality-related inquiries and issues, providing expert guidance and leadership across the organization.
• Communicate quality assurance and regulatory compliance expectations clearly to both internal teams and external partners.

QUALIFICATIONS & EXPERIENCE

Education:

• Advanced degree in Life Sciences, Pharmacy, Biotechnology, or a related field (PhD, MD, PharmD, or Master’s level).
• Additional certifications in clinical research (e.g., CCRP, CQA) are preferred.

Experience:

• At least 12-15 years of experience in clinical operations and clinical quality assurance, with a minimum of 8 years in a leadership role within the biotech or pharmaceutical industry.
• Strong background in oncology clinical trials, with demonstrated experience in early-phase and late-phase trial oversight.
• In-depth knowledge of GCP, FDA, EMA, ICH guidelines, and other relevant global regulatory frameworks.
• Experience with regulatory inspections and managing CAPAs.
• Proven track record of leading, mentoring, and building high-performance teams.
• Strong understanding of clinical data management, risk management, and quality systems.

Skills & Abilities:

• Exceptional leadership, communication, and interpersonal skills.
• Strong strategic thinking and problem-solving abilities.
• Ability to manage multiple projects and priorities in a fast-paced, high-growth environment.
• Excellent attention to detail, analytical skills, and a passion for ensuring clinical trials meet the highest standards of quality.
• Ability to influence and drive change across functional teams and at all levels of the organization.

WORKING CONDITIONS

• Office Setting Required.
• Authorized to work in the United States.

Fortvita is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Additional Legal Disclaimers

Reasonable Accommodations: Fortvita is committed to providing equal employment opportunities to qualified individuals with disabilities. If you require reasonable accommodation during the application process, please contact Fortvita Human Resources.

At-Will Employment: Employment with Fortvita is at-will. This means that either the employee or the employer can terminate the employment relationship at any time, with or without cause or notice.

KEY RESPONSIBILITIES:

• Independently lead the operational execution of oncology clinical trials from startup through close-out.
• Serve as the primary point of contact for internal teams and external partners, including monitor team, CROs, vendors, and clinical sites.
• Develop and maintain detailed project timelines, operational plans, budgets, and risk mitigation strategies.
• Support protocol development, informed consent forms, site feasibility assessments, and study document creation/review/update/archive.
• Drive site engagement and issue resolution, collaborating closely with the Medical Monitor, Regulatory, Clinical Supply, Central Sample Management and Data Management team ect..
• Manage and oversee CROs and vendors, ensuring quality and performance against contractual obligations and timelines.
• Facilitate cross-functional clinical study team meetings, ensure documentation of decisions and follow-up actions.
• Contribute to the development and continuous improvement of SOPs, tools, and operational best practices.
• Assist in preparation for regulatory inspections and submission of INDs/NDAs.
• Provide leadership in a hands-on, resource-limited environment, balancing strategic thinking with operational execution.

QUALIFICATIONS:

• Bachelor’s degree in Life Sciences or related field required; advanced degree (MS, PharmD, PhD) a plus.
• 5+ years of clinical operations experience, with at least 3 years managing oncology trials.
• Experience in managing cross-functional, global clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
• Demonstrated experience in vendor and CRO oversight, including contracts, budgets, and performance management.
• Strong understanding of FDA, EMA, ICH-GCP guidelines, and clinical development processes.
• Effective leadership, communication, organizational, and interpersonal skills within small-team environments.
• Ability to manage multiple projects and pivot quickly in a fast-paced, evolving setting.
• Proficiency with CTMS, EDC systems, and Microsoft Office Suite.
• Self-starter mindset with a collaborative spirit and willingness to “roll up your sleeves.”