Careers

Reports To: Stelexis CEO

Location: Remote

Job Summary

The SVP, Clinical Research, DMPK, and Safety Pharmacology, will make significant contributions to drug development by providing strategic clinical pharmacology/translational medicine, nonclinical DMPK, and safety guidance as well as tactical support to further the progress of our development programs and will bring additional depth and breadth in clinical development, nonclinical DMPK/safety strategy to our cross functional teams. This role will provide nonclinical and clinical input over a broad range of therapeutic areas and candidate types (small molecules, biologics) into specific programs spanning the drug development process from lead selection to postmarketing commitments. Support of company asset acquisition/partnering/sale through the due diligence process is also an expectation. The role also requires the ability to introduce the company to build and grow relationships. This role will also provide training/mentorship to colleagues and project teams on current and evolving nonclinical trends, practices, and safety guidances from global health authorities and participate in cross-functional peer review of development projects.

Responsibilities

• Work collaboratively with and leads Stelexis team members and external service providers to develop clinical pharmacology and quantitative program strategies that are fit-for purpose to enable development and regulatory decisions for IND/First in human to NDA/BLA.
• Lorem ipsum, dolor sit amet consectetur adipisicing elit. Nobis sunt quod sed provident hic laudantium quis autem, nisi voluptate fugit animi maxime illum eaque error reiciendis distinctio impedit blanditiis veniam?
• Lead due diligence and gap analyses of clinical, nonclinical DMPK and safety data packages
• Design nonclinical safety programs to support INDs, NDA/BLAs, MAAs and post registration studies.
• Outline studies, identify CROs to run these studies; manage the data/information analysis with our internal team to draft and finalize reports.
• 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.
• Develop new innovative and impactful clinical pharmacology approaches to processes and drug development strategies and can assemble a multidisciplinary team to execute the components of clinical pharmacology program.
• Leverage quantitative modelling and simulation tools to answer development questions and to design and inform clinical trial designs and clinical development strategy.
• Represent Stelexis at meetings and advisory hearings with global health authorities as a subject matter expert.
• Lead others in authoring and contributes to documents summarizing clinical pharmacology data and program strategy including CSRs, reports, and health authority documents.
• Interpret DMPK data with a focus on translation and applies information to support clinical pharmacology study design and strategy.
• Orchestrate nonclinical early development planning required to support of first in human studies.
• Contribute to training and mentoring for staff, develop junior staff for broader functional roles either as a direct manager or on project teams.
• Interpret and integrate NCA and pharmacometric results to support decision making including evolving clinical pharmacology strategy and development strategy.
• Actively collaborate with multidisciplinary peers (e.g., biostats, clinical, pharm/tox, CMC) and understands the multidisciplinary requirements of drug development.
• Assist/lead client response to any regulatory inquiries related to nonclinical safety studies
• Assist in developing early candidate and lead selection strategies
• Advise Stelexis on prioritization of their portfolio.
• Serve on cross-functional drug development teams as Clinical Pharmacology and Safety lead.
• Provide toxicology overview of full portfolio with potential investors to assist Stelexis in obtaining funding.
• Provide drug development diligence support for both buy and sell side activities.
• Co/authoring peer-reviewed manuscripts and publications.
• Reviews publications to keep apprised to keep apprised of new clinical pharmacology and therapeutic area developments.
• Involvement in program committees, workshops, and other professional organization meetings/sessions.
• Identify opportunities and leads company initiatives.
• Identify project opportunities, structure WO and budget, formulate teams and identify needs and resources necessary to execute projects. Author development plans when necessary.
• Manage a limited number of direct reports.

Qualifications

• Experience in both design and stewardship of clinical pharmacology components of clinical development plans and optimal application of pharmacometrics approaches to support decision making and regulatory success.
• PhD or PharmD degree or equivalent degree with specialization in toxicology, pharmacology or pharmacokinetics, or in a related scientific discipline.
• 30+ years of experience including clinical pharmacology experience in the pharmaceutical industry or government.
• Previous leadership experience in nonclinical development, clinical pharmacology, and drug development strategies.
• Experience 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 in oncology (preferentially also across other therapeutic areas, such as CNS, inflammation, and autoimmunity), with small molecules and biologics
• Experience with development of pediatric, orphan, and/or ultra-orphan products
• Experience generating safety margins based on nonclinical toxicity findings and target clinical exposure data
• Experience designing and conducting drug-drug interaction, special population, CV safety studies to support Registration label claims.
• Experience designing and executing nonclinical DMPK and clinical pharmacology studies.
• Experience with translational and clinical pharmacology work at different stage of development and for regulatory submissions (e.g. INDs, NDAs, and BLAs).
• 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.)
• Demonstrated track record in a functional role on cross functional dug development team.
• Applied understanding of the CMC, pharm/tox, biostats, clinical and other multidisciplinary requirements of drug development.
• Experience building and leading successful teams (within and/or across functions).

Your Skills & Abilities

• Advanced understanding of the drug development process.
• Strong initiative, self-motivation and demonstrated ability of coordinating multiple projects and/or tasks.
• Possess a strong focus on influencing at high levels, innovation, and Team Leads.
• Strong management skills.
• Ability to mentor and develop junior scientists on early drug development and strategy either as a direct mentor or on project teams.
• 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, Excel, and Power Point
• Proficient in the use of Pk modeling software (R, Phoenix, NONMEM)

Other Information

Number of Employees Supervised: could range from 1 to 5.

Percentage of Travel Required: As required to support corporate and business activities, typically less than 10%.

Special Requirements

• None