Clinical Trial Leader - Oncology

CLINICAL TRIAL LEADER I (CTL I)

DEPARTMENT: ONCOLOGY TRANSLATIONAL MEDICINE

MAJOR ACCOUNTABILITIES

1. Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; 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 of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.

2. 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.

3. Investigator/site relationship management is vital; must develop 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 and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s).

4. Lead and Matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management.

KEY PERFORMANCE INDICATORS

Job Dimensions (Indicate key facts and figures)

Number of Associates: Direct: None Indirect: Matrix management of clinical team F

inancial responsibility:Responsible for financial/resource decisions within scope of assigned authority.

Impact on the organisation: Well managed and effective trial team(s) resulting in the timely delivery of high quality clinical trial data and data analysis which enables strategic decisions within the clinical program. Novartis seen as a credible, ethical and preferred partner by key investigators in Oncology.

IDEAL BACKGROUND

Education: Advanced degree or equivalent education/degree in life science/healthcare strongly recommended. PhD preferred. Languages: Fluent English (oral and written) Experience: 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation. Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process. Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred. Hands-on experienceGood communication, organization and tracking skills.

Frank Arnold

Recruitment ConsultantMichael Bailey International is acting as an Employment Business in relation to this vacancy.