Clinical Trial Manager (Senior)

Position Title :

• (Senior) Clinical Trial Manager Reports to : Director of Clinical Operations Status : Regular, Full-Time, Exempt Location : Boston area (Hybrid – In office on T,W) Company Summary : Stratus Therapeutics is pioneering a new era in regenerative medicine with Stratus Prime™ — an off-the-shelf platform delivering Prime HSCs™ and Prime HPCs™ to restore the blood and immune systems where finding fully matched donors continues to be a challenge.
• Backed by leading life sciences investors, we are committed to developing universal, on-demand stem cell solutions to give physicians and their patients the power to replace the entirety of blood and immune function.
• This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.

Position Summary :

Specific responsibilities include, but are not limited to :

Regulatory Authority Inspection experience preferred Robust understanding of the drug development process Highly organized, outcome-oriented, self-motivated performance Ability to analyze complex issues objectively, using relevant KPIs, and applying a data-driven mindset, to develop and recommend trial-related plans, mitigations, and solutions.

Ability to thrive in a fast-paced and evolving environment High level of integrity, ethics, and discretion Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills Strong working knowledge of cGCP / ICH guidelines, and US and international clinical regulatory requirements Strong written and oral communication skills Comfortable navigating ambiguity and adapting quickly to shifting priorities Excellent problem-solving and decision-making skills with a “roll-up-your-sleeves” mindset Periodic travel related to project meetings and / or team meetings, may be required Ability and willingness to travel domestically and internationally (10-20%) Must be able to laugh and contribute to a positive work culture.   Education :