Clinical Trial Head

Medical Professional
Novartis AG
India, Hyderabad
Apr 2012
This job posting expired on June 19, 2012.
Job purpose

Accountable for all aspects of assigned clinical trials (Phase II through lifecycle management) including leading Clinical Trial Team(s). Number of clinical trials depends on the workload and complexity of the individual trials. Responsible for development of reports, as well as program level activities as assigned. Development of realistic clinical operations plans including timelines and budget planning.

Job description:
1. Accountable for the writing of the clinical protocols and related documents in collaboration with the medical director, program section leader or medical science expert: translate the approved trial concept into a quality executable protocol, lead the clinical trial protocol development process, including obtaining CSU/FSRC approval; 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 Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol.
2. Manage all aspects of clinical trials.
3. 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 investigator meetings. Lead protocol training meetings to support Novartis local medical organizations in the conduct of regional meetings. Accountable for all internal meetings related to the clinical trial.
4. Lead and matrix manage the global multidisciplinary clinical trial team (CTT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures from study start up through reporting phases: chair CTT meetings, report study progress and issues with their resolution plan to Global Clinical Teams; lead trial level interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations.
5. In collaboration with the medical director, program section leader or medical science expert, lead the clinical trial data ongoing scientific/medical review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
6. 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, provide operational leadership and strategic direction to our CRO and alliance partners.
7. Deliver a realistic clinical trial operational plan to the Operational team from design through reporting with stakeholder management negotiated and agreed to by the global program teams and operational review boards. Forecast trial resources needs accurately for strategic planning (headcount and external costs): accountable for the development, management and tracking of trial budget to approved cost-conscious targets working closely with the operations group. Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and management to ensure appropriate line function allocation. Foresee resource gaps, forecast needs and escalate in a timely fashion. Foresee potential risks and develop and execute an operational risk management plan.
8. In collaboration with the operational manager, assign short to mid-term responsibilities to CM who assists in the planning, conduct and reporting of clinical trials; independently manage the day-to-day interactions with the CMs; provide input to performance evaluations and promotion recommendations of the CMs. Direct talent and career development of direct reports, when assigned, including performance management (objective setting and performance appraisals). Delegate tasks in line with exhibited performance and capability of reports. Contribute to talent and career development of franchise staff through active participation in on-boarding, training and mentoring activities.
9. May serve on workstreams.
10. Contribute to program level documents and operational structure, including the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authorities questions.
11. Contribute to program strategy. Accountable that program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans) are developed and applied across all trials to ensure consistency of clinical dossier. Exercise good judgment, knowledge and broad perspective to determine a circumstance when the assigned trial complication has a broader implication for the program, and quickly communicate in a transparent fashion.
12. Responsible for implementation of best practices & standards for trial management within the franchise, including sharing lessons learned.
13. Draft Global Clinical Team meeting minutes.

Minimum Requirements

Minimum requirements

Advanced degree or equivalent education/degree in life sciences/healthcare is required. A Bachelor degree (or equivalent education/degree) coupled with at least 4 years’ experience in pharmaceutical clinical research may substitute for an advance degree.
• ≥ 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
• Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote). Ability to collaborate across partner functions to optimize performance and engage right people at the right time to identify and resolve issues.
• Experience in developing effective relationships with key investigators. Ability to stay abreast of industry trends through networking and self-directed learning.
• Proven ability to collaborate across partner functions to optimize performance and engage the right people at the right time to identify and resolve issues.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
• Advanced knowledge of Respiratory or Cardiovascular Therapy Area is preferable.
• Proven ability to assess individual performance capabilities, building on strengths and overcoming weaknesses, to optimize team efficiency in achieving goals, Mentorship experience preferred.
• Demonstrated excellence and reproducible results in clinical operations, including prioritization of critical path activities and franchise objectives. Competency in the application of project management principles to a trial and/or program.
• Ability to develop a communication plan within a trial or program, and to communicate in a clear, accurate, and concise manner.
Reference number: 94325BR