[Hiring] Director, Clinical Operations @Iovance Biotherapeutics

Role Description

The Director, Clinical Operations will lead and manage the assigned clinical operations team and have a key role in setting and executing departmental strategy.

• Oversees clinical trial agreements, budgets, expenditures and payments for clinical studies.
• Ensures the timely execution of clinical research programs/protocols from conception through final clinical study report.
• Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP).
• Maintains oversight of the conduct of the studies at the study centers.
• Key contributor to the preparation and management of clinical study protocols and protocol amendments.
• Assists with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
• Contributes to the review of Investigator Sponsored Trials (ISTs) & the relevant documentation to support these trials.
• Contributes to the creation of internal Iovance Biotherapeutics SOPs & Clinical work practice documents.
• Interfaces with Chief Medical Officer/Medical Monitor and cross-functional team members.
• Provide direct supervision of Clinical Operations team members, including performance management and development planning.
• Serve as company representative at external meetings, scientific congresses, etc.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel

• Available to travel up to 20% of the time.

Qualifications

• Bachelor’s Degree in health, or science related area.
• 12 to 16 years of pharmaceutical or biotech-related/clinical research experience (oncology/immuno-oncology experience required).
• Demonstrated experience in core and technical aspects of leading phase 1-4 and supporting Investigator-initiated trials.
• Demonstrated success in managing clinical studies within timeline and budget.
• Demonstrated managerial skills and strong interpersonal and communication skills.
• Able to build strong relationships with peers and partners.
• Able to assimilate information quickly and implement immediate change.
• Proven experience in using negotiating, influencing, and problem-solving skills.
• Able to set a high level of accountability and quality in deliverables.
• Proactive, self-directed, able to thrive and adapt in a rapidly changing environment.
• Embraces the ideas of others, promotes innovation.
• Flexible and dynamic approach to working in a fast-paced biotechnology company.
• In depth knowledge of PC operating systems and Microsoft Office.
• Exposure to CTM systems, EDC systems, and Safety/Pharmacovigilance databases.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally.
• Must have visual acuity to perform activities such as preparing and analyzing data and figures.
• This position requires repetitive motion and substantial movements of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress and multiple priorities simultaneously.
• Ability to meet deadlines.

Work Environment

• This job operates in a professional or remote office environment.
• Requires operating standard office equipment and keyboards.

Pay Transparency

The annual base salary we reasonably expect to pay is $225,000 — $240,000 USD. Individual pay decisions depend on various factors.

Equal Opportunity Employer

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to any characteristic protected by applicable law.