| || Location: Either Cambridge, MA or East Hanover, NJ. Please state in your application letter the location you would like to be considered for.
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. Within TM, Clinical Sciences and Innovation (CS&I) is a dynamic group of clinical scientists who plan and manage all NIBR’s Phase I and Phase IIa clinical trials worldwide, ensuring they run smoothly, on time and – most importantly – with patients’ interests to the fore.
As a Clinical Trial Leader (internal open position titles Clinical Scientist / Senior Clinical Scientist / Clinical Science Expert) you will be accountable for all aspects of the management and clinical execution of global early phase clinical trials across multiple therapeutic areas within Translational Medicine (TM). You lead the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting in accordance with timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures). You lead the global study team, participate on project level decision making, manage scientifically and operationally complex studies and may mentor junior team members. You may be responsible for program/project level activities for a compound or complex patient population.
1. Lead Phase I/IIa, including multi-country / multi-center / low to high complexity trials.
2. Lead and matrix manage the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and Project team members.
3. Lead all aspects of study planning, in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings.
4. Interact with investigator sites and CRAs/CROs/vendors to ensure efficient study set up and conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
5. Author the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
6. Lead/support the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/made available in a timely manner.
7. Contribute to the evaluation of clinical sites and external service providers for the conduct of TM studies in healthy volunteers and patients.
8. Oversee and coordinate the work of junior team members at the study/project level, ensuring clear delegation/assignment of duties are documented.
9. Provide advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned.
10. Oversee Clinical Study Report writing and publication of studies, either by directly contributing to and managing the report writing, or by liaising with a medical writer/narrative writer to ensure report is completed according to current requirements.
11. Oversee set up and maintenance of the Trial Master File (TMF) and pre/post audit activities for studies. Responsible/accountable for ensuring all relevant study documents are filed and archived according to the appropriate guidelines.
12. Support the Medical Expert on project documentation (e.g., briefing books, IBs, Annual Safety Reports, and responses to Health Authority questions), as assigned.
13. Contribute to identification and implementation of process improvements.
14. Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies.
| || The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. |
| || Education (minimum/desirable):
PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
Business-level written and oral English
1. At least 4+ years experience in international Pharma / Sponsor clinical trial management and execution, plus broad knowledge of drug development.
2. Excellent knowledge of Good Clinical Practice.
3. Track record of successfully leading multiple phase I and IIa clinical trials concurrently.
4. Demonstrated leadership and problem-solving skills.
5. Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
6. Clear written and verbal expression of ideas; an active/proactive communicator.
7. Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing a wide range of people, building strong positive relationships.
8. High level of customer orientation awareness and focus.
9. Used to working independently and in a team environment, being flexible and adapting in a changing environment.
10. Office and clinical trial software IT computer literacy.