Pioneering Medicines | Cambridge, MA Pioneering Medicines: Director, Clinical Development Operations

Flagship Pioneering; Cambridge (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading biopharmaceutical initiative is seeking a Director of Clinical Development Operations to drive clinical trial success by merging strategic insights with operational expertise. This hybrid role offers the chance to lead early-phase clinical studies, foster collaboration across multidisciplinary teams, and ensure regulatory compliance while managing vendor relationships.

Qualifications

• 10 years of drug development experience, including 5 years in clinical trial management.
• Experience with early-phase clinical trials and strong knowledge of drug development processes.
• Ability to manage multi-site global clinical trials and work independently.

Responsibilities

• Lead design and execution of early-phase clinical studies.
• Manage clinical trial operations and ensure compliance.
• Provide oversight of clinical trial budgets and timelines.

Skills

Project planning

Clinical trial management

Collaboration

Regulatory compliance

Education

Master's degree in life sciences

Tools

Clinical data systems

EDC

CTMS

Job description

Pioneering Medicines: Director, Clinical Development Operations

Cambridge, MA USA

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

About Flagship Pioneering:

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.

Position Summary:

Pioneering Medicines is seeking a curious, driven professional to support Clinical Development for one or more early development programs. This hybrid role combines the strategic insights of a Clinical Scientist with the operational expertise of a Clinical Trial Manager. The ideal candidate will have experience driving early-phase clinical development, including the design and execution of innovative trials.

The individual will be responsible for the successful conduct of clinical trials, focusing on both operational and administrative aspects with a hands-on approach. They will lead trial teams, provide supervision and oversight of third-party providers, and ensure timely performance of all services. Additionally, they will provide input into the operational aspects of protocol development and other clinical trial documents in close collaboration with clinical trial team members.

Key Responsibilities:

Clinical Strategy & Leadership

• Lead and/or support the design, execution, analysis, interpretation, and reporting of early-phase clinical studies within a matrixed and collaborative team environment.
• Collaborate across key internal workstreams including clinical development, pharmacometrics, safety, clinical pharmacology, biostatistics, data management, regulatory affairs, and quality to drive cohesive and compliant trial execution.
• Contribute to the development and refinement of organizational processes, procedures, and standards to promote operational excellence and regulatory compliance
• Prepare and participate in the preparation of presentations of trial data for internal and external parties.
• Organize and participate in investigator meetings and advisory boards to support trial execution and strategic planning; develop and maintain excellent working relationships with clinical investigators and key opinion leaders.
• Maintain up-to-date clinical and scientific expertise in relevant therapeutic areas, staying current by reviewing literature, attending conferences, and engaging with experts.
• Provide strategic input into clinical development plans within the Pioneering Medicines portfolio and across the broader Flagship ecosystem.

Clinical Trial Operations

• Manage essential elements of clinical trial planning and execution, including operational feasibility assessments, country/site selection, safety and medical monitoring oversight, and participation in key forums such as dose escalation meetings and study close-out activities.
• Lead or support development of critical clinical documents including protocols, investigator brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), IND/CTA submissions, EU CTR modules, Pharmacy Manuals, CRFs, safety reports, protocol deviations, DSURs, SAP, site recruitment materials, and other trial-related materials.
• Oversee clinical data systems and processes: support CRF design and user acceptance testing (UAT), monitor data review and discrepancy resolution, and coordinate CRA/site training as needed.
• Build, manage, and maintain clinical trial timelines, trackers, and operational status reports; proactively identify issues that may impact trial timelines, budget, or resource needs.
• Provide guidance and oversight of all trial budgets, including forecasting, tracking, reconciliation and risk management.
• Lead day to day supervision of clinical trial execution, with a focus on site start up, subject/patient enrollment, monitoring, compliance.
• Ensure timely collection of clinical data, samples and lab results.
• Lead development of Request for Proposal process for new vendors and organizes the cross functional study team to attend bid defense meetings and complete scorecards prior to selection
• Manage relationships with external partners (CROs, clinical trial sites, IRBs, central labs, IWRS providers, data safety monitoring boards ect.) to ensure high-quality and timely deliverables.
• Review monitoring visit reports (MVRs), conduct oversight monitoring activities, and escalate issues related to site or CRA performance.
• Develop and implement action plans to address protocol compliance, safety, data and administrative issues with investigational sites or CROs.
• Develop and implement operational tools to track and evaluate key performance indicators, risk mitigation plans, and program milestones.

Minimum Qualifications:

• Master's degree or higher (e.g., MS, PharmD, PhD, MD, NP, PA or equivalent) in life sciences or a related field is preferred.
• Minimum of 10 years of industry drug development experience, including:
• At least 5 years of experience in clinical trial management.
• At least 5 years in a clinical scientist, clinical director, or related strategic development role.
• Demonstrated track record of executing early-phase clinical trials, including first-in-human (FIH) and IND/CTA-opening studies; experience executing at start-ups or small biotechs.is a plus.
• Broad knowledge of drug development processes, with strong working knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Proven success managing multi-site global clinical trials, including oversight of study timelines, budgets, and vendors.
• Deep experience with CRO, vendor selection and management
• Ability to build strong collaborations with academic, biopharma, and consulting partners.
• Working knowledge of key clinical systems including EDC, CTMS, RTSM, and eTMF.
• Prior responsibility for maintaining a TMF, including QC and audit readiness.
• Strong project planning, clinical operations, and trial oversight skills.
• Effective in matrixed, fast-paced environments; ability to work independently and manage ambiguity.
• Experience in metabolic diseases, obesity, and/or rare diseases is highly desirable.
• Willingness and ability to travel domestically and internationally up to 20%.
• Global trial experience is a plus

This role offers a unique opportunity to contribute to the advancement of innovative therapies by integrating scientific acumen with operational excellence.

About Flagship Pioneering:

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.

Flagship Pioneering and our ecosystem companies arecommitted to equal employment opportunityregardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

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