Clinical Sciences Trial Leader (Multiple Roles)

Key Responsibilities:

•      Study Leader for predominantly low complexity, global studies, and may provide additional Clinical Sciences support to high complexity, global studies.

•      Lead a global cross functional Clinical Trial Team (CTT) to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines. Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners.

•      Lead or support the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents. Support development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable

•      Lead or support the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in CSR, and internal/external publications

•      Prepare, lead or support dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders.

•      Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert

The pay range for this position at commencement of employment is expected to be between $136,800 and $205,200 / year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Novartis EVP Manifesto.mp4

Essential Requirements:

 •     This position will be located at the Cambridge, MA site. This position will require 0-5% travel as defined by the business (domestic and/ or international).

•      Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/PharmD/Masters).

•      Approximately 2+ years’ experience in clinical trials/development.

•      Strong understanding of oncology/hematology and demonstrates high learning agility. Proficient in clinical trial methodology with an emphasis in early clinical development. Operational project management experience with an emphasis in early clinical development, including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated capability to interpret, discuss and present trial level data.

•      Demonstrates tolerance for ambiguity, willingness to adapt, and willingness to speak-up and challenge.

•      Demonstrates leadership and influence by creating a positive work environment by inspiring and encouraging mutual respect. Embraces a culture of diversity, inclusion, quality, innovation, and integrity.

•      Demonstrates strong interpersonal skills to build positive relationships.

•      Maintain expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies.

Preferred Requirements:

•      Radioligand therapy (RLT) experience preferred.