Director of Product

by | May 20, 2025 | Uncategorized

About the Role

Director of Product

  • United States
  • 2185

Job Description

Overview

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

Certara is seeking a visionary and strategically minded Director within the Certara Predictive Technologies Division to lead the evaluation and integration of cutting-edge technologies and methodologies into our nonclinical development platform and offerings. This leadership role will be impactful in shaping the direction of nonclinical safety science by identifying, evaluating, and implementing novel, non-animal, and mechanistic approaches to support drug discovery and development.  This role will also contribute to the development of software tools that generate data analytics, purpose-built visualizations, and standard reports from ongoing studies and accumulated historical nonclinical study data.  The ideal candidate will have a strong scientific foundation in nonclinical research and drug development, deep expertise in data sciences, a passion for data analytics, and a strong interest in innovation in areas such as organ-on-a-chip, computational modeling, in vitro/in silico approaches, and other New Approach Methodologies (NAMs).


Responsibilities

Strategic Leadership and Consulting

  • Help define and drive the vision and strategy for incorporating innovative, non-animal, and emerging technologies into nonclinical development and Certara’s Biosimulation Platform.
  • Work with Certara software developers to incorporate additional data analytics and reporting capabilities in existing and new applications
  • Collaborate with Certara software developers in the integration of AI/ML tools to improve scientific workflows and provide new scientific insights
  • Continuously scan the scientific and technological landscape to identify promising platforms and methodologies (e.g., virtual controls, micro-physiological systems, machine learning models, human tissue-based assays).
  • Engage with consortia, industry groups, and customers to assess partnership opportunities

Regulatory Engagement & Advocacy

  • Serve as a subject matter expert to interface with regulatory agencies regarding the use and qualification of nontraditional approaches.
  • Contribute to external working groups and consortia advocating for the regulatory acceptance of NAMs and for the standardization of data captured/reported using NAM approaches.
  • Pursue opportunities to influence the external environment via webinars, posters, white papers, and other publications.

Cross-Functional Collaboration

  • Work with customers as well as Certara discovery, clinical, and regulatory teams to ensure seamless integration of nonclinical data into overall program strategies.
  • Support education and change management efforts across Certara and our customer organizations to foster adoption of new methodologies.

Customer Consultation

  • Provide consultation services to customers to help them make the most of legacy and ongoing study data to summarize, visualize, model, and predict tox and safety outcomes.
  • Provide input on development software data analytics capabilities using nonclinical study data in standard format for customer projects and for inclusion in Certara software tools.
  • Promote usage of Certara tools capabilities with customers and regulators and identify opportunities for added value/improvement.
  • Collaborate with internal stakeholders and external customers to establish and align on translational strategies using NAMs.


Qualifications

  • PhD in quantitative Pharmacology or Toxicology, or related field.
  • Pertinent Board Certification desirable.
  • At least 8-10 years post doctorate experience in a drug development company, CRO, consulting organization, or FDA (R&D, nonclinical drug development).
  • Strong interest in data analysis with outstanding Data Sciences background and expertise.
  • Interest in New Approach Methodologies (NAMS) as well as traditional nonclinical study designs.
  • Drug development experience in one or more therapeutic areas, such as oncology, CNS, inflammation, autoimmunity, metabolic disease, or cardiovascular, with small molecules and/or biologics.
  • Deep understanding of electronic data standards including SEND.
  • Ability to lead and work in cross functional project teams.
  • Has served as a leader on teams and strongly demonstrated ability to work and excel in team collaboration.
  • Familiarity with SEND Explorer product a plus.
  • Excellent written, verbal, and inter-personal communication skills.
  • Possess a strong focus on innovation, influencing at high levels, and customer centricity.
  • Strong initiative, self-motivation, and coordination with other team members.

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