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Vice President, Pharmaceutical Development

FogPharma
Cambridge, Massachusetts, US
Full-time

Why join us?

Apply (by clicking the relevant button) after checking through all the related job information below.

FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions.

Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.

FOG-001, the company’s first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1 / 2 study for patients with advanced solid tumors, including colorectal cancer.

FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process.

FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass.

What’s the opportunity?

The VP, Pharmaceutical Development and External Manufacturing will be responsible for providing strategic direction, technical leadership and operational execution of CMC development activities in support of Fog Pharma’s clinical programs.

This individual will be responsible for collaboratively planning and executing phase appropriate development activities including process, formulation, and analytical development.

This is a pivotal role in a clinical-stage company, with the unique opportunity to directly contribute to the success of programs, hire a team, and influence the culture of the department.

This role reports to the Chief Technical Operations Officer.

Responsibilities

  • Provide strategic, operational and research leadership to drive the end-to-end process and product development of the pipeline, utilizing internal and external teams, from pre-clinical stages to commercialization.
  • Collaborate with Research, Manufacturing and Quality to ensure successful transfer of molecules, processes and analytical methods.

In addition, provide required technical support for investigations related to manufacturing and Quality.

  • Operate cross-functionally to design and implement CMC strategies and regulatory submissions aligned with world-wide regulatory requirements and industry best practices.
  • Prepare and manage complex CMC development plans, budgets and long-range planning.

What you’ll need to be successful :

  • 15+ years of proven experience in the pharmaceutical industry with a track record of developing and commercializing products along with 10+ years in a supervisory role managing (internal / external) CMC staff.
  • PhD in pharmaceutics, chemical engineering, organic chemistry or related field.
  • Prior experience in development and manufacturing of peptides is preferred.

Core Values

FogPharma is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients.

The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

  • Creative . We are creating a whole new class of medicine requiring creativity to solve challenges as they arise, which we have successfully done since the inception of the company.
  • Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
  • Execution-oriented. As we begin clinical development and large-scale manufacturing, the team is balancing creativity and nimbleness with relentless, rigorous and flawless execution.
  • Humble . We fully appreciate that science and technology and policy are in flux, and we balance deep experience with humility to ask fundamental questions and seek newly available solutions.

As an equal opportunity employer, Fog values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive Cambridge, MA 02140 www.fogpharma.com

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9 days ago
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