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About Certara

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Our goal is to enable the life sciences industry's use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

The Vice President, Toxicology will make significant contributions to Integrated Drug Development consulting by providing strategic nonclinical safety guidance and tactical support to further the progress of our client's development programs and will bring additional depth and breadth in nonclinical safety strategy to our cross functional teams. This role will provide nonclinical safety input over a broad range of therapeutic areas and candidate types (small molecule, biologics, drug-device combinations) into specific programs spanning the drug development process from lead selection to post marketing commitments. Support of client asset acquisition/partnering/sale through the due diligence process is also an expectation. This role will also provide training/mentorship to Toxicology colleagues and project teams on current and evolving nonclinical trends, practices, and safety guidance's from global health authorities and participate in cross-functional peer review of development projects, thereby adding value to the business mission by ensuring state of the art input on client projects and business initiatives (e.g., integrated practice networks).

Primary Responsibilities include collaborating with senior staff to:

• Lead, manage, and coordinate strategic nonclinical safety consulting and stewardship services for clients.
• Maintain leading edge awareness of key trends, practices, and regulatory guidances affecting nonclinical safety programs worldwide.
• Interface and work closely with key consulting leaders across Certara in planning new business development activities and executing projects.
• Lead due diligence and gap analyses of nonclinical safety data packages.
• Design nonclinical safety programs to support INDs, NDA/BLAs, MAAs and post registration studies.
• Outline studies and in partnership with clients, identify CROs to run these studies; manage the data/information analysis with our clients to draft reports and finalize with clients.
• Manage and critically review nonclinical safety content of regulatory documents for filing.
• Design investigative programs to address toxicology findings/issues/circumstances to determine human relevance.
• Represent client to regulatory authorities (as needed/requested).
• Assist/lead client response to any regulatory inquiries related to nonclinical safety studies.
• Assist in developing early candidate and lead selection strategies.
• Advise clients on prioritization of their portfolio.
• Serve on cross-functional drug development teams as toxicology lead.
• Provide toxicology overview of full portfolio with potential investors to assist clients in obtaining funding.
• Lead, mentor, and develop Toxicology colleagues to take on increasing complex responsibilities and tasks to expand Toxicology capacity for higher level client support.
• Develop and maintain policies, procedures, and training programs to support colleague growth and development.
• May manage a limited number of direct reports.
• Influencing the disciplines of safety pharmacology and toxicology in the context of drug development.

• PhD in quantitative Pharmacology or Toxicology, or related field.
• Pertinent Board Certification desirable.
• At least 15 years post doctorate experience in a drug development company, CRO, consulting organization, or FDA (R&D, nonclinical drug development).
• Excellent knowledge of global health authority regulations/guidances related to nonclinical safety.
• Experience in activity participating in due diligence evaluations.
• Experience with within-discipline or cross-disciplinary teams to create or update new drug development strategies or tools to streamline/optimize nonclinical safety aspects of drug development.
• Experience as a leader of a team that delivered nonclinical safety support for successful first-in-human programs through marketing approval.
• Experience in the design and outsourcing of GLP and non-GLP toxicology and safety pharmacology studies.
• Experience in the strategic and tactical design of mechanistic/investigational studies to address nonclinical safety issues raised by global health authorities or clients.
• Experience in addressing comments/questions from global health authorities.
• Drug development experience across multiple therapeutic areas, such as oncology, CNS, inflammation, autoimmunity, metabolic disease, or cardiovascular, with small molecules and biologics.
• Experience with development of pediatric, orphan, and/or ultra-orphan products.
• Experienced in the generation of safety margins based on nonclinical toxicity findings and target clinical exposure data.
• Experience authoring and reviewing the relevant nonclinical sections of IND's, NDA/BLA's, MAAs, and other regulatory submission documents (SPA, pre-IND/Type B/Type C meeting briefing documents etc.

Skills & Abilities:

• Excellent understanding of the drug development process, including the critical role of nonclinical safety assessment.
• Ability to lead, work, and build effective relationships in cross functional project teams.
• Desire to influence the external environment to advance nonclinical safety assessment.
• Excellent written, verbal, and inter-personal communication skills.
• Demonstrated ability to effectively and proactively influence direct reports, peers, and all levels of management to improve client support and meet business objectives.
• Self-starter, independent and practical thinker, and strong and passionate team leader.
• Strong client and alliance management skills.
• Ability to work across functions to implement company initiatives.
• Ability to work well within a team in a multidisciplinary environment.
• Proficient in Microsoft Word and Power Point.

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.