Director/Senior Director, Clinical Development & Product Concept Explorations

About Pioneering Medicines:

 

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

 

Pioneering Medicines, a division 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 physician-scientist, board-certified in medical hematologist & oncology with pharma/biotech experience to lead Clinical Development for one or more early development programs. Experience in early phase oncology drug development is ideal. This individual would report to the SVP, Head of Clinical Development and Leader, Explorations, Pioneering Medicines.

 

The core accountability for this role is the design and execution of clinical development plans and trials therein, including designing clinical trials, writing trial protocols, study execution, and medical monitoring. This includes collaboration with partner companies and CROs. This individual will also provide input into portfolio strategy and clinical development to select companies across the Flagship Ecosystem.

 

Depending on the individual and their experience and interest, they may also participate in product concept explorations. Explorations are the iterative hypothesis generation and refinement process that Flagship has used to create novel platforms. Pioneering Medicines has adapted this process to the development of new therapeutic product concepts. Given the clinical development expertise and medical training of the individual, their contribution would center around the challenges requiring solutions – the unmet need and the patient journey – both in and outside of their training and prior experience.

 

Flagship is an experiment in institutional, entrepreneurial innovation practiced in the context of a small company with an insurgent mindset.  We are seeking individuals with an entrepreneurial spirit, strong communication skills, and comfort working in and contributing to a dynamic and cross-functional team environment.  The level of the role will be commensurate with the education and years of experience of the identified candidate.

 

 

 

Key Responsibilities:

• Provide expertise in the establishment and execution of clinical development programs and work with key stakeholders to develop the Target Product Profile, regulatory and market access strategies
• Drive and oversee the design, execution, analysis, interpretation, and reporting of clinical studies, in a matrixed and highly collaborative team environment
• Provide medical leadership for internal workstreams including clinical operations, pharmacovigilance, biostatistics, and regulatory affairs
• Plan, organize, and direct the activities of clinical trials, including development and authoring of clinical study protocols and amendments, Investigator Brochures, Development Safety Update Reports, Investigational New Drug Applications, Clinical Trial Applications, and other regulatory submissions and responses and clinical study reports.
• Interact with external thought leaders, including advisory boards, to support clinical and translational development
• Provide medical monitoring support, including evaluation of safety, pharmacology, and efficacy of studies
• Serve as a key representative interacting with data safety monitoring boards, other study committees, regulatory bodies, and CROs.
• Serve as primary responsibility individual for compliance with PM's SOPs and adherence to ICH, GCP, and regulatory guidelines.
• Participate in high impact, high profile product Explorations across therapeutic areas and diseases in context of Pioneering Medicines’ portfolio strategy
• Contributes to a high-energy team spirit and high functioning team and leads in a way that i