Clinical Operations Lead, Ad/Director

Position Summary

Upstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing from high-quality investors. We have acquired a clinical stage asset with proof of concept in inflammation and seek to add at least one more clinical program to build a pipeline in immunology/inflammation. Our offices are in Waltham, MA. We have a hybrid working model, with Tuesdays-Thursdays in the office and Mondays and Fridays flexible to work remotely if desired.

We seek a resourceful, purpose-driven, integrative thinker for an important role overseeing our clinical trials and contributing to clinical development plan strategy across our lead and secondary indications. This key role will plan, oversee and drive delivery of clinical studies in a fully outsourced model. Additionally, this individual will provide guidance and shared learning throughout planning and implementation, as well as ensure clinical operational deliverables and timelines are met across the development program(s). This position will report to the Head of Clinical Operations.

The successful candidate will have a scientific background and have led programs through first in human studies and later stage development. This position requires a strong ability to synthesize scientific, clinical and business considerations into a cohesive study and program operational strategy. This individual will use outstanding cross-functional skills to achieve study and program goals and will develop a solid understanding of the clinical indications being pursued including knowledge of the patient needs, development plan, applicable regulatory guidance as well as the competitive landscape in the therapeutic space.

Excellent written and oral communication skills are required to represent the trials and program to internal and external stakeholders, as is the desire and ability to work in a small, fast-paced, and patient-focused environment. Adaptability to changing study and program needs and challenges and an innovative approach to problem solving will be important characteristics of the successful candidate.

Responsibilities

• Oversee high quality implementation, execution and delivery of studies by CROs in alignment with timeline and budget plan.
• Partner with the CRO SMT lead to ensure effective risks identification & mitigation strategies as well as proactively identify & resolve issues.
• Plan, execute and manage all aspects of single and multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines in close collaborations with key stakeholders and Clinical Research Organizations (CROs)
• Ensure compliance with internal policies and procedures, GCPs, and applicable regulations; ensure inspection readiness
• Provide oversight and management for all relevant CROs and vendors including contracting and clinical budgets; develop contingency plans for clinical trials.
• Contribute to CRO/vendors identification, qualification and selection processes as applicable.
• Establish an open team culture defined by transparent communication, clear goal setting, and risk-based oversight
• Develop and drive implementation of clinical operational strategy for successful delivery of assigned clinical studies. Drive the Study Management Team to enable the development of operationally feasible, and efficient clinical protocols and associated plans.
• Contribute to and execute the clinical development plan strategy for assigned programs in alignment with TPP.

Qualifications

• 8 - 10+ years of relevant clinical development and operations experience, in clinical operations leadership roles, leading global clinical studies/programs
• Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.

Skills, Knowledge & Abilities

• Deep knowledge of global regulatory and compliance requirements for clinical research, local country requirements and ICH GCP, including experience with global regulatory inspections.
• Excellent critical and strategic thinking, with strong ability to understand the big picture as well as the important details that may impact the big picture.
• Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications
• Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing.

Interested candidates please send resumes to: [email protected]