Senior Clinical Sciences Trial Leader (Multiple Positions)

Job Description Summary

#LI-Hybrid

Location: Hybrid. Cambridge, MA or East Hanover, NJ.

About the role:
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.

 

Job Description

Key Responsibilities:

• Responsible for financial and resource decisions within scope of assigned authority

• Study Leader and/or Clinical Scientist for predominantly medium to high complexity, global studies and may provide additional Clinical Sciences support to high priority, high complexity, global studies

• Lead 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

• Lead 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. Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met

• Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations

• Lead 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 and lead 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

• Proactively lead risk mitigation discussions, risk management and implementation at the trial level

• Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners

• Collaborate with key partners to set vendor strategy and timelines for assigned studies

• 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

• Contribute to talent and career development of staff. In collaboration with the relevant manager, contributes to hiring/interview/onboarding and mentoring process for new hires

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.

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Essential Requirements:

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