Jobs · North Carolina

Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy

Sarepta Therapeutics · North Carolina, United States · 3 wk ago
Hybrid$186k–$232k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes "Why Sarepta? Why Now?" (intro), "What Sarepta Offers", "The Importance of the Role", "The Opportunity to Make a Difference", "More About You", "What Now?" (includes hybrid, salary range). Also "What Sarepta Offers" includes benefits list: Physical and Emotional Wellness, Financial Wellness, Support for Caregivers. Also mention full list on website. We must not repeat job title as heading. No Job ID. Remove boilerplate: EEO, e-Verify, etc. Also remove application instructions? There's "We encourage you to apply." That's application instruction? Might be considered boilerplate; but it's part of "What Now?" maybe keep? The instruction says remove application instructions. The line "We encourage you to apply." is an application instruction; we should drop it. Also "Candidates must be authorized to work in the U.S." maybe keep as requirement? It's a requirement; not boilerplate. Keep. We need sections only when there is real specific content. Use

for section headings. Use
  • for any list of duties/requirements/benefits. Use

    for prose. We need to decide sections: maybe "About Sarepta" (intro), "What Sarepta Offers" (benefits), "Role Overview" (importance of the role), "Responsibilities" (Opportunity to Make a Difference), "Qualifications" (More About You), "Work Arrangement & Compensation" (What Now? includes hybrid, salary). Could also combine "What Sarepta Offers" as Benefits. We must not create Pay/Schedule/Benefits sections unless posting actually states them. Benefits are stated (Physical and Emotional Wellness, Financial Wellness, Support for Caregivers). So we can have Benefits section. Pay: salary range stated, so we can have Pay section. Schedule: hybrid mentioned, so we can have Schedule section (or Work Arrangement). The instruction says use heading "Schedule" if posting actually states schedule. It says hybrid, you will be expected to work on site... So we can have Schedule heading. We need to avoid filler like "commensurate with experience" etc. The posting includes "The salary offer is commensurate with Sarepta’s compensation philosophy..." That's filler; we should not include that sentence as it's vague. We should keep the salary range but drop the commensurate sentence. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep the details about responsibilities, qualifications, etc. Let's extract content: Intro: "Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients." We can put that under an "About Sarepta" heading (or maybe "About the company"). What Sarepta Offers: "At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us" We need to turn the list into

    • . The list items: Physical and Emotional Wellness, Financial Wellness, Support for Caregivers. We can keep the prose before list as

      . The Importance of the Role: "The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This is a highly visible and team-facing role." We can put that as a paragraph under heading "Role Overview" or "Importance of the Role". Use heading "Importance of the Role" maybe. The Opportunity to Make a Difference: list of responsibilities: - Drives the development and execution of the quantitative pharmacology strategies across all stages of drug development through product registration - Leads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reports - Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical development - Serves as functional lead for global regulatory strategies and HA engagements - Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums. We need to put these as

      • under heading "Responsibilities" or "Opportunity to Make a Difference". Use heading "Responsibilities". More About You: qualifications: - PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years of experience working in clinical pharmacology or pharmacometrics - Strong understanding of clinical pharmacology principles, strong hands-on experience with PK/PD modeling analysis, and experience in regulatory interactions - Excellent communication, multitasking, and collaboration skills - Experience in NONMEM & R highly preferred - siRNA and/or CNS experience is preferred We can put under heading "Qualifications". What Now? includes hybrid work arrangement and salary range: - "This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time." - "The targeted salary range for this position is $185,600 - $232,000 per year." - Also "Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges." (maybe keep as part of Pay section) - "The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity." (filler, drop) - "Candidates must be authorized to work in the U.S." - "Sarepta Therapeutics offers a competitive compensation and benefit package." (maybe filler, but it's substantive? It's generic; could drop as boilerplate.) - Also "Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify." (boilerplate, drop) We need to keep "Candidates must be authorized to work in the U.S." as requirement. We can have sections: Pay (salary range), Schedule (hybrid), and maybe "Work Authorization" as part of Qualifications or separate? Could add under Qualifications. But we should not create many thin sections; prefer few substantive sections. Could combine Pay and Schedule into one section "Compensation & Work Arrangement". However headings list includes Pay, Schedule, Benefits. We could keep separate if they have content. We have Benefits section with list. We have Pay section with salary range. We have Schedule section with hybrid description. We also have About Sarepta intro. We have Responsibilities. We have Qualifications. We have Importance of the Role (maybe combine with Responsibilities? But they are distinct: importance is a brief description; responsibilities are detailed list. Could keep both. We must not repeat job title as heading. Let's craft HTML:

        About Sarepta

        Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

        What Sarepta Offers

        At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

        • Physical and Emotional Wellness
        • Financial Wellness
        • Support for Caregivers

        For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

        Importance of the Role

        The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This is a highly visible and team-facing role.

        Responsibilities

        • Drives the development and execution of the quantitative pharmacology strategies across all stages of drug development through product registration
        • Leads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reports
        • Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical development
        • Serves as functional lead for global regulatory strategies and HA engagements
        • Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums

        Qualifications

        • PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years of experience working in clinical pharmacology or pharmacometrics
        • Strong understanding of clinical pharmacology principles, strong hands-on experience with PK/PD modeling analysis, and experience in regulatory interactions
        • Excellent communication, multitasking, and collaboration skills
        • Experience in NONMEM & R highly preferred
        • siRNA and/or CNS experience is preferred
        • Candidates must be authorized to work in the U.S.

        Pay

        The targeted salary range for this position is $185,600 - $232,000 per year.

        Schedule

        This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

        We should not include any extra boilerplate like "Sarepta is making a good faith effort..." etc. We dropped that. Check for any leftover filler: The sentence "Sarepta Therapeutics offers a competitive compensation and benefit package." we dropped. Good. Check for any duplicated lines: none. Check for any mention of "EEO" etc: removed. Check for any mention of "e-Verify": removed. Check for any mention of "We encourage you to apply.": removed. Check for any mention of "What Now?" heading: we didn't use that heading; we split into Pay and Schedule. Check

Similar jobs