Global Oncology leader seeks experienced Clinical Trial Head

Our client, one of the industry leaders in global oncology, is looking for an experienced clinical development professional to be accountable for all aspects of assigned oncology global development clinical trials including leading Clinical Trial Team(s) (CTT).

If you are a clinical development professional and would like to enhance your career, please email a Word document of your resume to [Click Here to Email Your Resumé].  If this opportunity does not match your interest, we have a number of additional roles that could work for you.

Responsibilities:

Accountable for the writing of clinical protocols and related documents in collaboration with other key team members: lead the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors and Advisors of the major local medical organizations to ensure country feedback is adequately integrated into protocol.

• Participate in development of effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings to support local medical organizations in the conduct of regional meetings. Accountable for all internal meetings related to the clinical trial.

• Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT meetings, report study progress and issues with their resolution plan to International Clinical Teams; lead trial level interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and local medical organizations.

• In collaboration with other key team members, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.

• Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Relationship Manager in the Contract Management Department.

• Forecast trial resources needs (headcount and external costs): accountable for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology (e.g. CRO management, POM).

• Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and TA management to ensure appropriate line function allocation.

• In collaboration with the Lead CTH, assign short to mid-term responsibilities to CM who assist in the planning, conduct and reporting of clinical trials; independently manage the day-to-day interactions with the CMs.

• Accountable for overall management of CMs. Identify training needs to foster high level of performance, support career development through quality development plans. Proactively manage performances issues. Establish annual objectives according to OGD priorities.

• Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.