Jobs · Healthcare · New York

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

Sarepta Therapeutics · New York, United States · 3 wk ago
HybridHealthcare$186k–$232k/yrFull-time
We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. Must not include Job ID etc. Remove boilerplate like EEO, etc. Must preserve all substantive info. Let's parse the posting. 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." - "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" - "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." - "The Opportunity to Make a Difference 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." - "More About You 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" - "What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. 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. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. 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. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify." We need to remove boilerplate: EEO, e-Verify, etc. Also remove "What Now?" maybe part of description but we can incorporate. We need sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content. - About the role: Could be the intro about Sarepta and role importance. Could be "Why Sarepta? Why Now?" plus "What Sarepta Offers"? Actually "About the role" likely includes description of role importance and opportunity. We'll include: The Importance of the Role and The Opportunity to Make a Difference. - Responsibilities: The bullet list of duties: lead clinical pharmacology and pharmacometrics deliverables, clinical dose selection/refinement, predictive PK/PD modeling, etc. Also drives development and execution of quantitative pharmacology strategies, leads clinical pharmacology expertise, responsible for model-based data analyses, serves as functional lead for global regulatory strategies, maintains leading-edge knowledge, publishes manuscripts, presents at conferences. - Requirements: PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years experience in clinical pharmacology or pharmacometrics. Also authorization to work in US. - Qualifications: maybe same as requirements? Could separate: Strong understanding of clinical pharmacology principles, hands-on experience with PK/PD modeling analysis, experience in regulatory interactions, experience in NONMEM & R highly preferred, siRNA and/or CNS experience preferred. - Skills: Excellent communication, multitasking, collaboration skills, solution-oriented, critical thinker, comfortable with ambiguity and candor, kindness and integrity. - Benefits: What Sarepta Offers: culture, work-life integration, benefits supporting Physical and Emotional Wellness, Financial Wellness, Support for Caregivers. Also link to website for full list. - Pay: targeted salary range $185,600 - $232,000 per year. Also mention salary offer commensurate etc. But we should not include filler like "commensurate with experience" as heading content? Actually we can include the sentence as prose under Pay section, but we must not include placeholder like "commensurate with experience" as a heading. It's okay to have that phrase in prose. However we must not create Pay section unless posting actually states them. It does state targeted salary range, so we include Pay. - Schedule: hybrid position, expected to work on site at one of Sarepta’s facilities in the US and/or attend Company-sponsored in-person events from time to time. So we can include Schedule. We must not include boilerplate like EEO, e-Verify, etc. Also remove "Sarepta Therapeutics offers a competitive compensation and benefit package." maybe redundant with Benefits but we can keep as part of Benefits? It's generic; but it's not boilerplate? It's a statement about compensation and benefit package; could be considered boilerplate but it's not EEO. Might keep but it's vague. Safer to omit generic statements that add no new info. The Benefits section already covers specifics. So we can omit that line. Also remove "Candidates must be authorized to work in the U.S." that's a requirement; we keep under Requirements. Now produce HTML fragment with

headings and appropriate

or

  • . We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep details like specific numbers, areas of wellness, etc. Let's craft. Section About the role: combine "Why Sarepta? Why Now?" and "What Sarepta Offers"? Actually "What Sarepta Offers" is benefits; but we have separate Benefits section. So About the role could be the intro about Sarepta's mission and the role importance. We'll include:

    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.

    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.

    The Opportunity to Make a Difference 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.

    But we need to avoid run-on sentences; we can keep as is. Responsibilities: Could be the same as Opportunity to Make a Difference? Actually responsibilities are the duties. We'll list bullet points: - Lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Phase 3 and product registration), with 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. - Drive development and execution of quantitative pharmacology strategies across all stages of drug development through product registration. - Lead clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, and study reports. - Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical development. - Serve as functional lead for global regulatory strategies and health authority (HA) engagements. - Maintain leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts, and present at scientific conferences and forums. We need to keep the exact phrasing? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we should not paraphrase too much; we should keep the original wording as much as possible. However we can format as list items but keep the sentences. Let's extract exact sentences from text: From "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." From "The Opportunity to Make a Difference": "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." Note there are missing punctuation; but we keep as is. We could split into list items each starting with a verb. But we must not invent or summarize away detail; we can keep the sentences as they are, maybe separate into
  • each. Now Requirements: "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" Also "Candidates must be authorized to work in the U.S." We

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