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parabilismed
Страна
США
Зарплата
265 000 $ – 320 000 $
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SeniorУдалённоПолная занятость

Senior Director, Clinical Pharmacology & Pharmacometrics

Оценка ИИ

Высокая оценка обусловлена конкурентной заработной платой, работой над прорывными технологиями (Helicons™) и лидерской ролью в стабильной биотехнологической компании. Наличие четкого диапазона зарплаты и бонусов добавляет прозрачности и привлекательности.


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Сложность вакансии

ЛегкоСложно
Оценка ИИ

Роль требует исключительного сочетания глубоких научных знаний (PhD/MD), более 12 лет опыта в индустрии и владения сложным инструментарием моделирования (NONMEM, R). Высокий уровень ответственности за глобальные регуляторные стратегии и руководство кросс-функциональными командами делает эту позицию крайне сложной.

Анализ зарплаты

Медиана285 000 $
Рынок250 000 $ – 330 000 $
Оценка ИИ

Предлагаемая зарплата в $265k-$320k находится на верхнем уровне рыночных ожиданий для позиции Senior Director в Кембридже, штат Массачусетс, который является одним из самых дорогих и конкурентных биотех-хабов в мире. С учетом бонусов и опционов, совокупный доход полностью соответствует или даже превосходит средние показатели по отрасли для опытных руководителей в области фармакометрии.

Сопроводительное письмо

I am writing to express my strong interest in the Senior Director, Clinical Pharmacology & Pharmacometrics position at Parabilis Medicines. With over 12 years of experience in quantitative drug development and a proven track record of leading clinical pharmacology strategies for complex modalities, I am eager to contribute to the advancement of your Helicon™ platform and lead candidates like FOG-001. My expertise in integrating PK/PD modeling and MIDD approaches aligns perfectly with your mission to unlock high-impact, previously undruggable protein targets.

Throughout my career, I have successfully navigated global regulatory landscapes and led cross-functional teams to optimize dose selection and trial designs. I am particularly impressed by Parabilis's commitment to innovation, including the integration of AI/ML in drug development—a field where I have actively applied advanced tools to enhance decision-making. I look forward to the possibility of bringing my leadership and scientific rigor to your team in Cambridge to help drive your focused pipeline toward registration and beyond.

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Откликнитесь в parabilismed уже сейчас

Присоединяйтесь к Parabilis Medicines, чтобы возглавить разработку инновационных лекарств нового класса и изменить жизни пациентов!

Описание вакансии

Why Join Us?

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs.

What’s the opportunity?

The Senior Director of Clinical Pharmacology & Pharmacometrics (CPP) provides scientific, functional, and operational leadership across assigned drug development programs. Reporting to the VP, Head of Clinical Pharmacology, this individual is responsible for designing and executing program-level clinical pharmacology and pharmacometric strategies, ensuring their integration into global development plans. The Senior Director works cross-functionally with Clinical Development, DMPK, Regulatory, and Biostatistics to optimize dose selection, study design, and quantitative decision-making from early to late development.

Key Responsibilities

Program Leadership and Strategy

  • Lead the design and implementation of clinical pharmacology and pharmacometrics strategies for assigned programs, from early development through registration and lifecycle management.
  • Integrate PK/PD modeling, exposure–response, and quantitative pharmacology to support data-driven decision-making and model-informed drug development (MIDD).
  • Collaborate with the VP, Head of Clinical Pharmacology, to ensure alignment with the overall departmental and organizational strategy.
  • Serve as the global CPP lead on cross-functional project teams, providing scientific guidance on study design, dose rationale, and risk–benefit assessment.
  • Partner with Translational Medicine, Biomarker Sciences, and Biostatistics to incorporate quantitative and mechanistic insights into clinical development plans.

Operational Excellence

  • Oversee planning, conduct, and interpretation of clinical pharmacology studies (e.g., FIH, DDI, food effect, special population studies).
  • Ensure timely and high-quality preparation of study protocols, analysis plans, and reports.
  • Author and review clinical pharmacology sections of regulatory submissions (IND, CTA, NDA, BLA) and represent the function in interactions with global health authorities (FDA, EMA, PMDA, NMPA).
  • Support cross-functional integration of modeling and simulation into global regulatory strategies and provide scientific input to agency queries.

Modeling, Simulation & Innovation

  • Apply and oversee population PK/PD, PBPK, exposure–response, and disease modeling approaches to support dose selection, trial design, and risk management.
  • Promote the use of innovative modeling techniques, including AI/ML, Bayesian methods, and quantitative systems pharmacology.
  • Drive implementation of new tools and processes that enhance the impact and efficiency of model-informed development.

Leadership & Mentorship

  • Provide scientific and functional leadership to clinical pharmacology and pharmacometrics team members working on assigned programs.
  • Mentor and develop staff to foster scientific excellence, collaboration, and continuous learning.
  • Contribute to departmental initiatives, best practice development, and knowledge sharing in partnership with the VP and other senior leaders.
  • Represent Clinical Pharmacology in cross-functional governance discussions and external scientific forums.

What you’ll need to be successful:

  • PhD, PharmD, MD, or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related quantitative discipline.
  • 12+ years of experience in clinical pharmacology, pharmacometrics, or quantitative drug development in the biopharmaceutical industry.
  • Demonstrated success in designing and leading clinical pharmacology strategies at the program or portfolio level.
  • Strong understanding of regulatory expectations (FDA, EMA, PMDA, NMPA) for clinical pharmacology and modeling & simulation.
  • Proficiency in modeling and data analysis tools (e.g., NONMEM, Monolix, Phoenix NLME, MATLAB, R).
  • Proven ability to lead in matrixed environments, influence cross-functional teams, and drive decision-making.
  • Experience with both small molecules and biologics; exposure to novel modalities (e.g., gene or cell therapies) preferred.
  • Excellent communication, collaboration, and presentation skills.
  • Demonstrated use of AI tools in your current role and responsibilities is required. Advanced or innovated use of AI is a strong plus.

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

  • Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
  • In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
  • Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
  • All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $265,000-$320,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive    |     Cambridge, MA 02140    |    www.parabilismed.com

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Навыки

  • Clinical Pharmacology
  • Pharmacometrics
  • PK/PD
  • NONMEM
  • Monolix
  • Phoenix NLME
  • MATLAB
  • R
  • PBPK
  • AI
  • Machine Learning
  • Regulatory Submissions
  • Drug Development

Возможные вопросы на собеседовании

Кандидат должен продемонстрировать опыт использования количественных методов для принятия ключевых решений в разработке.

Опишите случай, когда результаты фармакометрического моделирования радикально изменили дизайн клинического исследования или стратегию выбора дозы в вашем проекте.

Позиция Senior Director подразумевает активное взаимодействие с FDA, EMA и другими агентствами.

Расскажите о вашем опыте защиты стратегии клинической фармакологии перед регуляторными органами. С какими критическими вопросами вы сталкивались?

В описании вакансии подчеркивается важность использования ИИ.

Как именно вы интегрируете инструменты искусственного интеллекта или машинного обучения в свои текущие рабочие процессы для повышения эффективности фармакометрии?

Работа ведется над инновационными пептидами Helicons™, что требует гибкости мышления.

В чем, по вашему мнению, заключаются основные сложности фармакокинетики и фармакодинамики при работе с клеточно-проникающими альфа-спиральными пептидами по сравнению с традиционными малыми молекулами?

Роль предполагает руководство и наставничество в матричной структуре.

Как вы подходите к менторству сотрудников и разрешению конфликтов между функциональными группами (например, между отделами трансляционной медицины и биостатистики)?

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parabilismed
Страна
США
Зарплата
265 000 $ – 320 000 $