Pioneering Medicines: Associate Director / Director, Clinical Operations at Flagship Pioneering, Inc.
About the role
Flagship Pioneering is looking for an Associate Director or Director of Clinical Operations to oversee early-phase clinical programs.
This position is crucial to our expanding clinical portfolio, and we seek a candidate who excels in a dynamic environment and is prepared to take full responsibility for program management from the outset.
Key facts
Location: Cambridge, MA, USA
Engagement: Full-time
Team: Pioneering Medicines
What you'll do
Act as the operational lead for one or more early-phase clinical trials (Phase 1/2), managing the entire program lifecycle from initiation to closure and reporting.
Collaborate with the Clinical Development Team, which includes clinical scientists, safety experts, biostatisticians, data management professionals, and regulatory affairs specialists.
Lead the design of clinical trials and development plans, which encompasses protocol development, feasibility assessments, site selection, and recruitment strategies.
Engage in critical regulatory activities such as dose escalation meetings, preparations for Data Safety Monitoring Boards (DSMB), and IND/CTA submissions.
Prepare and present updates on program operations to internal stakeholders and create materials for investigator meetings and advisory boards.
Manage site start-up, patient enrollment, monitoring, and compliance with protocols, ensuring accountability throughout.
Write and review essential clinical documents, including protocols, informed consent forms, and clinical study reports.
Oversee clinical data systems, ensuring proper design,



user acceptance testing, and data integrity.
Develop and maintain accurate timelines, trackers, and operational reports, proactively addressing any risks to timelines, budgets, or resources.
Handle trial budgets, including forecasting and tracking, while implementing plans to address any variances.
Ensure timely collection of clinical data and maintain the quality of the Trial Master File (TMF).
Lead the request for proposal (RFP) process for vendors associated with the program, coordinating cross-functional meetings and supporting selection decisions.
Manage relationships with CROs, clinical sites, and other vendors to guarantee high-quality deliverables on time.
Review monitoring visit reports and conduct oversight to address any performance issues with sites or CROs.
Develop action plans to resolve issues related to protocol compliance, safety, and data quality.
Monitor vendor performance metrics and report on program milestones.
Contribute to the enhancement of organizational processes and operational standards.
Assist with team onboarding and knowledge sharing, potentially mentoring junior team members over time.
Stay updated on ICH-GCP, FDA, EMA, and other regulatory requirements to ensure compliance throughout trials.
Requirements




A Bachelor's degree or higher in life sciences or a related field is preferred; advanced degrees (MS, PharmD, PhD) are a plus.
At least 10 years of experience in drug development, with a minimum of 5 years in clinical trial management, demonstrating clear program ownership.
Proven experience in executing early-phase clinical trials, including first-in-human (FIH) and IND/CTA-opening studies.
Experience in startup or small biotech environments is highly valued.
Comprehensive understanding of drug development processes and regulatory requirements (ICH-GCP, FDA, EMA).
Successful management of multi-site global clinical trials, including oversight of timelines, budgets, and vendor relationships.
Extensive experience with CRO and vendor selection and performance management.
Familiarity with clinical systems such as EDC, CTMS, RTSM, and eTMF, with prior TMF quality control experience required.
Ability to thrive in a fast-paced, matrixed environment with a high level of autonomy.
Strong collaboration and communication skills, along with effective project planning and problem-solving abilities.
Experience in metabolic diseases, obesity, oncology, or rare diseases is highly desirable.
Willingness to travel domestically and internationally up to 10%.
Practical notes
The salary range for this position is $148,000 - $236,500.
Pioneering Medicines provides healthcare coverage, an annual incentive program, retirement perks, and a range of additional benefits.
This information is based on a good faith estimate and may be subject to change.
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📌 Pioneering Medicines: Associate Director / Director, Clinical Operations (Hobart)
🏢 Flagship Pioneering
📍 Hobart