The Clinical Trial Head is responsible for management of all aspects and ensuring high quality of assigned clinical trials (phase I-IV, Expanded Access, registries, and Compassionate Use) including leading Clinical Trial Team(s) (CTT).
1. Manages phase I-IV clinical trials including EAP, Compassionate Use and non-interventional studies. Accountable for the writing of clinical protocols and related document. Leads the clinical trial protocol development process. Collaborates with the Medical Directors and Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol.
2. Supports the GMA medical director in development of effective working relationship with investigators to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related scientific meetings. Leads investigators meetings and protocol training meetings. Develops effective working relationships with stakeholders.
3. Leads the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance.
4. In collaboration with the GBMD, leads the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
5. Develops clinical outsourcing specifications (SSW) incorporation with respective line functions to facilitate bid templates and selection of CROs; manages interface with CROs in cooperation with the Contract Management Department
6. Accountable for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
7. Contributes to the development of clinical sections of regulatory documents.
8. Manages the on-boarding, and training of new staff. Mentor TA staff. May serve as faculty member for training programs.
9. Manages third-party Investigator Initiated Trials (ITT), Regional and Locally Sponsored Novartis Trials – provides feedback on study proposals, review submitted study concepts/protocols for core requirements via the Study Express System.
10. Implements Individual Patient Support Program as assigned. Manages physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply.
11. May supervise other team members as assigned in collaboration with the GBMD. Assigns short to mid-term responsibilities. Identify training needs to foster high level of performance, support carrier development through quality development plans.
Education: Degree in health or life sciences
Experience / Skills:
= 5 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
Proven ability to work independently, as well as ability to collaborate and work effectively in teams. Ability to lead a multidisciplinary trial team in a complex matrix environment and build effective relationship with stakeholders
Demonstrate effective Project Management skills as well as ability to prioritize based on business need
Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required. Experience with complex or randomized studies
Working knowledge hematology/oncology/endocrinology knowledge of therapeutic area is preferred.
Experience developing effective relationships with investigators.
Novartis is an EEO/AA employer M/F/D/V. This position will be filled at a level commensurate with experience.
About Novartis Oncology :
At Novartis Oncology, our employees worldwide share a common mission: discover and develop innovative medicines to fight cancer. We are passionate about providing a broad range of new remedies and practical solutions that change the way patients live with cancer. In the last five years, Novartis Oncology products have helped improve, extend, and save the lives of more than 2 million people with breast cancer, chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), multiple myeloma, prostate cancer, carcinoid syndrome, and other cancers. With more than 7800 employees operating in over 50 countries, Novartis Oncology has a truly global reach. We have the advantage of extraordinarily talented and globally diverse employees who, through shared goals and different perspectives, are dedicated to improving and extending the lives of patients around the world.
Novartis Awards and Recognition :
- Working Mother’s 100 Best Companies 2012 and 2013
- Barron's World’s Most Respected Companies 2012 (Novartis ranked as the most respected healthcare company)
- Fortune’s World’s Most Admired Companies 2012 and 2013 (Novartis ranked as the most admired pharmaceutical company)