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Position:
VP, Head of Nonclinical Development and Pharmaceutical Candidate Optimization

Employer:
Agios Pharmaceuticals

Description:

Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular biology and metabolism to transform the lives of patients with cancer and rare genetic diseases/genetically defined diseases. We are growing rapidly with an active research and development pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development in both oncology and rare genetic diseases.  Specifically, the ongoing indication expansion in multiple trials of our PKR agonist, mitapivat and Discovery research on this mechanism, provides a particularly exciting and diverse opportunity for the future leader of this discipline to have an immediate and significant impact.

 

Agios Pharmaceuticals is searching for a dynamic Vice President to lead our Nonclinical Development and Pharmaceutical Candidate Optimization (PCO) organization.  This individual will provide leadership, acumen and strategy in Agios’ drug development (Clinical Pharmacology and nonclinical Drug Safety) and PCO space, positioning our drug candidates competitively with both best and first-in-class product profiles.  This includes advancing clinical programs, and discovery projects while working closely with multi-disciplinary teams.   This is an excellent opportunity for candidates local to our Cambridge, MA offices or those that would work remotely from across the US and are able to travel periodically to our central location.

 

Nonclinical Development and Pharmaceutical Candidate Optimization refer respectively to the development and discovery facing aspects of the scientific disciplines described below.

 

Key Responsibilities

 

  • Lead Drug Metabolism and Pharmacokinetics (DMPK), Bioanalytical, Biotransformation, Clinical Pharmacology and Pharmacometrics in the core “DMPK” function, together with nonclinical drug safety evaluation and a nascent exploratory pharmaceutics group.  This leadership encompasses and bridges Discovery, Development, Technical Operations, and Commercial facing parts of the organization, and includes deep scientific-technical leadership, people management, talent development, recruiting and strategic portfolio management
  • Develop and execute scientifically rigorous strategies with your leadership team to inform major drug discovery, development and regulatory decisions through all phases of drug development
  • Represent the nonclinical development and PCO disciplines as a thought leader, utilizing state-of-the-art approaches to accelerate program progression and address critical program issues, leveraging data and outcomes modeling and simulation, biostatistics, and machine learning approaches as applicable. 
  • Promote and exemplify the visibility of our research through AAPS, ISSX, SOT, ASCPT, ACCP, ACoP, PAGE and other national/international organizations.
  • Working closely with the CSO, draft, plan, implement, and execute against organizational objectives.  Demonstrate drive, visibility and influence in key company decisions including development candidate selection, patient dosage selection, clinical strategy, and regulatory filing strategy.
  • Leveraging internal and external expertise and your own network, place complex drug discovery and development issues in perspective with clear plans for time-bound execution.
  • Demonstrate an understanding of risk assessment across your multiple departmental dimensions, driving bold strategies and pushing the limits of appropriate risk acceptance within research programs
  • Actively partner with Discovery departments, Clinical Medicine, Clinical and Technical Operations and Commercial functions in driving asset and company strategy to fruition.
  • With your leadership team, oversee CRO selection, mentorship, and activities, build external consultant networks and setting the right balance of internal versus external capabilities.
  • Contribute to driving the shape of global regulatory filings including preparation of regulatory documentation and active participation in meetings with regulatory agencies
  • Leverage disciplinary excellence, visibility and influencing skills to provide Agios’ external face in the pharmaceutical industry for the disciplines in your NCD and PCO functions


Qualifications/Experience:

Minimum Requirements 

  • PhD and/or MD MD/PhD, DVM PhD and experience in one or preferably more of DMPK, clinical pharmacology, pharmacometrics, nonclinical toxicology and pharmaceutics disciplines with at least 15 years of relevant and current technical and leadership experience.
  • Experience leading and applying pharmacometric approaches such as population PK, PKPD, and disease progression models to support research and development
  • Excellent quantitative skills and a vision to leverage the science of dosage projection/simulation, drug-drug interactions, drug transporters, quantitative systems pharmacology, mechanistic toxicology risk assessment, pharmaceutics, machine learning in a cutting edge discipline.
  • Documented experience in drug development process including multiple regulatory submissions
  • Able to perform independently in a fast-paced environment managing multiple priorities simultaneously
  • Excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly
  • Strong collaborative skills and ability to influence others through effective presentations
  • Excellent analytical and problem solving skills

 

Preferred Qualifications

  • Prior experience working with multiple national and international CROs
  • Specific experience in oncology and/or genetically defined disease (GDD) areas or those therapeutic areas associated with GDD   Significant experience across multiple therapeutic areas and multiple geographies is considered an advantage.

 



Location: Cambridge, MA

Contact: Jill Donovan - jill.donovan@agios.com

Post Date: 8/6/2020 9:47:23 AM
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