Jobs · New Jersey

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

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

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Remove boilerplate like EEO, legal, etc. Also remove application instructions. Keep all substantive info. Let's parse the posting: - 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." That's about the company, could be "About the role"? Actually "About the role" is more about the job. This is about Sarepta. Could be "About Sarepta" but not in allowed headings list. Allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can only use those. So we need to map content to these headings. - "What Sarepta Offers" section: describes benefits: Physical and Emotional Wellness, Financial Wellness, Support for Caregivers. Then says "For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us". So we have benefits content. - "The Importance of the Role": describes responsibilities: lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), 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": bullet list of duties: Drives development and execution of 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": 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. - "What Now?" includes: solution-oriented, critical thinkers; comfortable with ambiguity and candor; relish challenging yourself; place kindness and integrity at the forefront; 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 "Sarepta Therapeutics offers a competitive compensation and benefit package." maybe keep? It's somewhat generic but could be considered part of benefits? Might be considered boilerplate. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The EEO line is boilerplate, remove. Also "Sarepta Therapeutics offers a competitive compensation and benefit package." maybe not boilerplate but it's generic; but we already have benefits section. Might be okay to keep but could be considered filler. Safer to remove generic statements that don't add specifics. However we need to preserve ALL substantive information. That line is not substantive beyond what we already have. Could be considered filler. I'd remove it. Also "Candidates must be authorized to work in the U.S." is substantive (requirement). Keep. Now we need to decide sections. We have: - About the role: Could include the intro about Sarepta? Actually "About the role" maybe should contain description of the role importance and opportunity. Could combine "The Importance of the Role" and "The Opportunity to Make a Difference". But we need to avoid duplication. We'll create sections:

About the role

with paragraphs describing the role's purpose and impact. Alternatively we could have

Responsibilities

with list of duties.

Requirements

with qualifications (PhD, experience, etc.)

Skills

with communication, multitasking, collaboration, NONMEM & R, siRNA/CNS experience.

Benefits

with list: Physical and Emotional Wellness, Financial Wellness, Support for Caregivers.

Pay

with salary range.

Schedule

with hybrid expectation. We must not create sections if content is vague like "commensurate with experience". We have specific salary range, so Pay section is okay. Schedule: we have hybrid expectation: 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. That's specific enough. Now we need to ensure we don't repeat job title as heading. We aren't. We must not include Job ID/requisition numbers. We must output only HTML fragment. Let's craft. First, About the role: combine intro about Sarepta and role importance? The intro about Sarepta is company info, not role. But we could still put under About the role: "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." That's about Sarepta, but maybe okay as context for role. Then we can add: "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." That's from Importance of the Role. Then maybe we add the Opportunity to Make a Difference as responsibilities list. But we have separate Responsibilities section; we could put the bullet list there. Thus About the role could be a brief paragraph about the role's purpose. Let's decide:

About the role

The Director of Quantitative & Clinical Pharmacology will lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Phase 3 and product registration), focusing on clinical dose selection/refinement and predictive PK/PD modeling using population and statistically-based methods, as well as mechanistic and translational approaches. This is a highly visible, team‑facing position at Sarepta, a leader in Duchenne muscular dystrophy therapies and genetic medicine.

That seems good. Now Responsibilities: list from Opportunity to Make a Difference. We'll create
  • items. 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 health authority (HA) engagements - Maintains leading‑edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums Now Requirements: maybe combine qualifications and experience. Requirements: - PhD in Pharmaceutical Sciences, mathematics/engineering or related field - Minimum 7 years of experience working in clinical pharmacology or pharmacometrics - Strong understanding of clinical pharmacology principles - Strong hands‑on experience with PK/PD modeling and analysis - Experience in regulatory interactions - Candidates must be authorized to work in the United States Now Skills: maybe list preferred/experience. Skills: - Excellent communication, multitasking, and collaboration skills - Experience with NONMEM & R (highly preferred) - siRNA and/or CNS experience (preferred) Now Benefits: list from What Sarepta Offers. Benefits: - Physical and Emotional Wellness - Financial Wellness - Support for Caregivers We could also note that full list is on website, but we can keep as is. Now Pay: salary range. Pay: - Targeted salary range: $185,600 – $232,000 per year We could also note that offer is commensurate with factors, but that's generic; maybe we can include a sentence: "The salary offer is commensurate with Sarepta’s compensation philosophy and considers education, training, experience, market conditions, role criticality, and internal equity." That's somewhat specific but still somewhat generic. The instruction says: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. The posting does state the salary range and also mentions the offer is commensurate with factors. That's not filler; it's specific about factors. So we can include a paragraph after the range. Thus Pay section could have

    Targeted salary range: $185,600 – $232,000 per year. The offer is commensurate with Sarepta’s compensation philosophy and considers education, training, experience, external market conditions, criticality of the role, and internal equity.

    Now Schedule: hybrid expectation. Schedule: - This is a hybrid position; 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 could also note that it's hybrid. Now we must ensure we don't include any boilerplate like EEO, e-Verify, etc. Remove. Now output HTML fragment. Let's construct:

    About the role

    The Director of Quantitative & Clinical Pharmacology will lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Phase 3 and product registration), focusing on clinical dose selection/refinement and predictive PK/PD modeling using population and statistically-based methods, as well as mechanistic and translational approaches. This is a highly visible, team‑facing position at Sarepta, a leader in Duchenne muscular dystrophy therapies and genetic medicine.

    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

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