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 Clinical Scientist with pharma/biotech experience to support Clinical Development for one or more early development programs. Experience in early phase clinical development, including the design and execution of innovative trials, is essential. The core accountability for this role is to support the design and execution of clinical trials, including the development of processes and standards, crafting and writing trial protocols and supporting documents (e.g., IBs, ICFs and IND components), and study execution, working in close collaboration with clinical operations. This role will collaborate across groups within Pioneering Medicines and with Flagship Pioneering partner companies and CROs. This individual will report to the Development Project Lead / Clinical Lead, Pioneering Medicines. 

This individual will also provide input into early asset companies within the Pioneering Medicines’ portfolio and to companies across the Flagship Ecosystem. Given their clinical development and medical expertise their contribution will center around helping to define unmet need across the patient journey and determining early healthy volunteer and patient trials can enable proof of concept to drive value. 

Key Responsibilities:  

• Assist and, as appropriate, lead the design, execution, analysis, interpretation, and reporting of clinical studies, in a matrixed and collaborative team environment. 

• Collaborate on and contribute to internal workstreams including those involving clinical operations, clinical pharmacology, pharmacometrics, pharmacovigilance, biostatistics, and regulatory affairs. 

• Participate in cross-functional efforts to develop processes, procedures, and standards to drive delivery excellence and regulatory compliance across the organization. 

• Manage/perform key elements of trial execution and planning, including operational feasibility, site selection, study communications (e.g., protocol amendments, administrative letters), safety and medical monitoring, dose escalation meetings, and relevant reports (e.g., study close-out, status updates). 

• Lead/assist development of protocols, clinical study reports, IND/CTA, EU CTR, IBs, Pharmacy Manuals, TFLs, CRFs, safety reviews, site interactions, protocol deviations, DSUR, and other study related activities/materials as required. 

• Manage relationships with data safety monitoring boards, other study committees, IRBs, central labs, IWRS, and CROs. 

• Lead innovation in clinical trial execution through an agile trial team approach and implementing new technology to drive innovation in clinical trials. 

• Interact with external thought leaders, including investigators and advisory boards, to support clinical development. 

• Assist in the clinical development planning of early product concepts across therapeutic areas and diseases in Pioneering Medicines’ and Flagship Pioneering company portfolios. 

Minimum Qualifications: 

• Bachelor’s degree with at least 10 years clinical trial experience, MS with at least 8 years clinical trial experience, or MD (or equivalent)/PharmD/PhD with 5 years clinical trial experience; prior experience in a clinical scientist / clinical director role with a track record in trial execution required. 

• Requires clinical research operational knowledge, project planning/management, communication and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Strong expertise in vendor management required. 

• Early clinical development experience, including experience with FIH and IND/CTA opening trials, is required; Metabolic Diseases and/or Obesity clinical trial experience a plus. 

• Broad understanding of drug development, including working knowledge of relevant ICH and GCP guidelines and regulations. 

• Experience managing multi-site early clinical trials is required. 

• Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations. 

• Excellent leadership skills and proven ability to foster team productivity and cohesiveness in a dynamic, team-based, matrixed environment.  

• Excellent decision-making, analytical and strong financial management skills are essential to this position.  

• Ability to execute with limited supervision.  

• • Ability to travel domestically and internationally as required (up to 20%) to support trials and development. 

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.