Flagship Pioneering

Pioneering Medicines: Associate Director / Director, Clinical Operations

Flagship Pioneering • $148K — $236K *
Cambridge, MA 02139In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree or higher in life sciences or related field preferred; advanced degrees such as MS, PharmD, PhD are a plus.
  • 10+ years of industry drug development experience, with 5 years specifically in direct clinical trial management.
  • Demonstrated experience managing early-phase clinical trials, particularly First-In-Human (FIH) and IND/CTA-opening studies.
  • Experience in startup or small biotech environments is highly valued.
  • Broad knowledge of drug development processes and strong understanding of regulatory requirements including ICH-GCP, FDA, and EMA.
  • Proven track record in managing multi-site global clinical trials, overseeing timelines, budgets, and vendor relationships.
  • Working knowledge of clinical systems such as EDC, CTMS, RTSM, and eTMF, with experience in TMF quality and audit readiness.

Responsibilities

  • Serve as operational lead for early-phase clinical trials, managing all aspects from start-up to close-out.
  • Collaborate with clinical scientists, safety teams, and regulatory affairs for effective trial design and execution.
  • Lead the drafting and review of key clinical documents and ensure regulatory compliance throughout the clinical program.
  • Manage clinical data systems and processes by reviewing data, training teams, and overseeing site performance.
  • Control trial budgets by forecasting and tracking expenditures, while flagging discrepancies and creating mitigation strategies.
  • Maintain oversight of vendor performances and implement corrective actions when compliance or quality issues arise.
  • Contribute to the enhancement of company processes and standard operating procedures, supporting team growth through mentoring.

Benefits

  • Healthcare coverage including medical and dental.
  • Participation in an annual incentive program.
  • Retirement benefits with a company match.
  • Opportunities for professional development and training.
  • Flexible leave policies to accommodate work-life balance.
Full Job Description
Position Summary:

Pioneering Medicines is seeking an Associate Director or Director, Clinical Development Operations to join our growing team and take direct ownership of one or more early-phase clinical programs.

This role is being created in direct response to the expansion of Pioneering Medicines' clinical portfolio. The ideal candidate thrives in a lean, high-ownership environment and is ready to step into full program stewardship from day one.

Key Responsibilities:

Clinical Program Ownership
  • Serve as the operational lead for one or more early-phase clinical trials (Phase 1/2), owning end-to-end program execution from study start-up through close-out and CSR.
  • Collaborate closely with the Clinical Development Team including clinical scientists, pharmacometricians, safety, biostatistics, data management, regulatory affairs, and quality.
  • Lead or contribute to the design of clinical trials and clinical development plans, including protocol development, operational feasibility assessments, country/site selection, and recruitment strategy.
  • Participate meaningfully in dose escalation meetings, DSMB preparations, IND/CTA submissions, and other key regulatory and governance milestones.
  • Prepare and present program operational updates to internal stakeholders; develop materials for investigator meetings and advisory boards.

Clinical Trial Execution
  • Lead site start-up, patient enrollment, monitoring, protocol compliance, and study close-out activities with a hands-on, accountability-driven approach.
  • Author and/or review clinical documents including protocols, IBs, ICFs, CSRs, pharmacy manuals, CRFs, DSURs, SAPs, and other trial-related materials.
  • Oversee clinical data systems and processes: CRF design and UAT, data review and discrepancy resolution, CRA training, and site performance oversight.
  • Build and maintain accurate trial timelines, trackers, and operational status reports; proactively escalate timeline, budget, or resource risks.
  • Manage trial budget including forecasting, tracking, and reconciliation; flag variances and develop mitigation plans.
  • Ensure timely collection of clinical data, samples, and lab results; maintain TMF quality and audit readiness.

CRO, Site & Vendor Management
  • Lead RFP processes for assigned program vendors; coordinate cross-functional bid defense meetings, complete scorecards, and support selection decisions.
  • Manage day-to-day relationships with CROs, clinical sites, IRBs, central labs, IWRS providers, and DSMBs to ensure high-quality, timely deliverables.
  • Review monitoring visit reports (MVRs), conduct oversight monitoring, and escalate issues related to site or CRO performance as needed.
  • Develop and implement action plans to address protocol compliance, safety, data quality, and administrative issues at investigational sites or with CROs.
  • Track and report on vendor KPIs, risk mitigation plans, and program milestones.

Organizational Contribution
  • Contribute to the development and continuous improvement of organizational processes, SOPs, templates, and operational standards.
  • Support team onboarding and knowledge transfer; may provide informal mentorship to junior colleagues or contractors over time.
  • Maintain current knowledge of ICH-GCP, FDA, EMA, and other applicable regulatory requirements; apply expertise to ensure trial compliance.

Qualifications:
  • Bachelor's degree or higher (MS, PharmD, PhD a plus) in life sciences or a related field preferred.
  • Minimum 10+ years of industry drug development experience, including:
  • At least 5 years of direct clinical trial management experience with clear program ownership.
  • Demonstrated experience executing early-phase clinical trials including FIH and IND/CTA-opening studies.
  • Experience at startups or small biotech companies highly valued.
  • Broad knowledge of drug development processes; strong working knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements.
  • Proven success managing multi-site global clinical trials including oversight of timelines, budgets, and vendors.
  • Deep experience with CRO and vendor selection, onboarding, and performance management.
  • Working knowledge of key clinical systems including EDC, CTMS, RTSM, and eTMF; prior TMF QC and audit readiness experience required.
  • Ability to operate effectively in lean, matrixed, fast-moving environments with a high degree of autonomy.
  • Excellent cross-functional collaboration and communication skills; strong project planning and problem-solving capabilities.
  • Experience in metabolic diseases, obesity, oncology and/or rare diseases highly desirable.
  • Willingness and ability to travel domestically and internationally up to 10%.

The salary range for this role is $148,000 - $236,500. Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.

About Flagship Pioneering

Flagship Pioneering is a life sciences innovation enterprise that conceives, creates, resources, and develops first-in-category life sciences companies. The firm operates through its Flagship Labs unit, which is a dedicated innovation foundry that invents and launches transformative companies. Flagship Pioneering has created over 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents. The firm's portfolio includes companies in the fields of therapeutics, health technologies, and sustainability. Flagship Pioneering was founded in 2000 and is headquartered in Cambridge, Massachusetts.
Learn more about Flagship Pioneering
Size
500 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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