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 explicit 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 benefits, 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 (Town of Cambridge)
🏢 Flagship Pioneering
📍 Town of Cambridge