Associate Director, Clinical Operations – Oncology

Specific Responsibilities and Skills for Position

• Provides leadership and oncology expertise for the successful management of international clinical trials
• Contributes to the strategic implementation of a clinical development program(s).
• Demonstrated ability to manage international phase oncology clinical trials within designated program budgets and timelines is required.
• Must possess a proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.
• Extensive experience in developing RFPs, selection of CROs/vendors and management of external resources is required.
• Ability to initiate, participate in and/or lead departmental or interdepartmental strategic initiatives.
• Participates in development of SOPs, Clinical Study Reports, INDs, NDAs and other clinical, regulatory and safety documents.
• Provides input into the management of the Clinical Operations department.
• Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Recruits, hires, mentors and manages Clinical Trial Manager/Clinical Program Manager/Clinical Trial Management Associate direct reports and supports their professional development.
• Leads cross-functional study management team and must have good influencing skills with study stakeholders.
• Travels nationally and internationally as required.

Knowledge & Other Requirements

• Excellent interpersonal skills, and demonstrated ability to lead is required.
• Oncology development experience.
• Experience in managing staff as well as mentoring and developing junior staff is required.
• Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Experience in developing RFPs and selection and management of CROs/vendors.
• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
• Ability to examine functional issues from a broader organizational perspective.
• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
• Has an expert-level of knowledge of one or more disease or therapeutic areas, as evidenced by independence in assuming study management leadership and oversight for multiple clinical studies across a worldwide clinical program.
• Routinely drives to resolve cross-functional issues related to study execution.
• Lead by Example leadership mentality.
• Typically reports to Director or above.
• Provides matrix management and leadership to multiple larger-scale study teams.
• Acts as a process improvement and innovation champion; identifying opportunities to enhance operational excellence / innovation and staff to drive initiatives, e.g., tech and innovation collaborations. Drives and/or leads departmental and interdepartmental strategic initiatives.
• Actively contributes and may represent Clinical Operations in project strategy meetings or Global Development Team (GDT) as applicable.
• Actively consults on short- and long-term TA / FA strategy and operational plans as appropriate, including consistent messaging upon implementation.
• Leads highly complex assignments that enable multiple functions, teams and therapeutic area clinical programs to achieve their objectives within targeted timelines and allocated resources.
• Champions our Leadership Commitments and Values with an appropriate balance of portfolio delivery, resource management, and organizational excellence / innovation while being able to effectively manage more complex assignments.
• With little to no direction, determines how to structure and manage assigned studies across a program(s) to ensure project deliverables are completed on-time, within-budget and to the quality expected.
• Develops change management skills in other team members by providing proactive change management leadership and guidance.

 Required Education & Years of Experience and Skills

• 10+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline. MS/MA or higher will need 8+ yrs experience in clinical operations.
• Minimum of 6 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams.
• Experience in company sponsored clinical trial management is required.
• Oncology development experience required.