[Hiring] Associate Director, Clinical Operations @Iovance Biotherapeutics

Role Description

The Associate 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.
• Involves close supervision of external contract organizations responsible for site interaction, monitoring, data management, biostatistics, IRB interaction, and other critical activities.
• 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.
• Contributes to the review of Investigator Sponsored Trials (ISTs) and relevant documentation.
• 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.
• Provides direct supervision of Clinical Operations team members, including performance management and development planning.
• Serves as company representative at external meetings, scientific congresses, etc.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned.

Qualifications

• Bachelor’s Degree in health or science related area.
• 8+ 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 and 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.

Requirements

• 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.

Benefits

• The annual base salary ranges from $180,000 to $205,000 USD.

Company Description

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors.