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.