- Страна
- США
- Зарплата
- 203 200 $ – 284 600 $
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Director, Early Development - Clinical Science
Отличная вакансия уровня Director в стабильной фармацевтической компании с прозрачным диапазоном зарплаты и расширенным пакетом льгот. Гибридный формат работы и офис в Ирвайне добавляют привлекательности.
Сложность вакансии
Высокий уровень сложности обусловлен требованием ученой степени (MD, PhD или PharmD) и более чем 10-летнего опыта в биотехнологиях. Роль требует сочетания глубокой научной экспертизы и лидерских качеств для управления кросс-функциональными командами.
Анализ зарплаты
Предлагаемая зарплата ($203k - $284k) полностью соответствует рыночным стандартам для позиции Директора по клиническим разработкам в США, особенно в биофармацевтическом кластере Калифорнии. Верхняя граница диапазона даже несколько превышает медиану, что делает предложение конкурентоспособным.
Сопроводительное письмо
I am writing to express my strong interest in the Director, Early Development - Clinical Science position at Tarsus Pharmaceuticals. With over a decade of experience in clinical development and a proven track record of leading cross-functional teams through complex early-phase trials, I am confident in my ability to drive scientific rigor and operational excellence for your development programs. My background includes extensive experience in protocol development, regulatory document authoring, and strategic collaboration with KOLs, which aligns perfectly with the requirements of this role.
Throughout my career, I have successfully managed clinical trial designs and executions, ensuring compliance with GCP and SOP standards while maintaining a 'hands-on' approach to data review and problem-solving. I am particularly drawn to Tarsus's commitment to patient-centric innovation and your collaborative culture. I look forward to the possibility of bringing my expertise in early-stage clinical science to your Irvine-based team and contributing to the advancement of your promising pipeline.
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Присоединяйтесь к Tarsus Pharmaceuticals и возглавьте разработку инновационных методов лечения в офтальмологии!
Описание вакансии
About the Role
The Director, Early Development - Clinical Sciences will create early development clinical plans, program outlines, study designs and clinical study essential documents. This individual will be accountable for leading the cross-functional Study Teams to meet study deliverables and represent clinical development in core team and investigator meetings as needed.
This role will collaborate closely with cross-functional teams such as Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Finance and Legal to drive efficient and scientifically rigorous early development clinical work.
Let’s talk about some of the key responsibilities of the role:
- Maintains direct ownership of early development clinical deliverables, actively contributing to protocol development, document authoring, data review, study-level problem solving and execution decisions to ensure scientific rigor and operational excellence.
- Shape clinical plans including timelines, budgets and oversight of clinical teams.
- Author and critically review key clinical and regulatory documents, including protocols, SAPs, CSRs, IBs and clinical value dossiers, ensuring scientific rigor, regulatory alignment and quality execution.
- Lead and oversees the training of study investigators on protocol and on clinical trial procedures.
- Conduct research to develop foundational education material to inform the early development program strategies.
- Interpret clinical data and support data-driven decisions.
- Serve as program lead on early development Core teams, investigator meetings and scientific advisory boards.
- Engage with internal and external stakeholders, including KOLs and regulators.
- Exhibits and fosters key leadership competencies, including an innovative mindset, strong business acumen, an outcome-driven orientation, and a commitment to growing and expanding the capabilities and capacity of the team.
- Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs and others to ensure robust trial design, scientific and operational alignment and execution .
Factors for Success:
- Advanced degree in sciences (e.g. PharmD, MD, PhD) with deep experience in early clinical development
- Experience in ophthalmology is preferred; dermatology or infectious diseases a plus.
- Minimum of 10 years of biotech/pharmaceutical clinical development experience, with a minimum of 8 years leadership in clinical trial management experience required
- Established leadership track record with evidence of excellent performance-based people management experience, problem solving, collaboration, cross functional leadership and effective communication skills.
- Expertise with SOPs, GCPs and regulatory and compliance guidelines for clinical trials.
- Must be willing to be “hands on” and delve into details
Leadership Competencies - This role requires mastery of the Tarsus Leadership Competencies for Leading People, including:
- Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
- Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
- Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
- Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders’ decision-making capability, and creating systems that support performance and growth.
- Emotional Intelligence - Foster trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure.
Few Other Details Worth Mentioning:
- The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
- We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
- This position reports directly to our SVP, Development
- Some travel may be required – up to 30%
At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $203,200 - $284,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.
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Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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Навыки
- Leadership
- GCP
- Clinical Development
- Ophthalmology
- Regulatory Affairs
- Medical Writing
- S&OP
- Biostatistics
- Clinical Trials Management
- Pharmacology
Возможные вопросы на собеседовании
Проверка опыта в разработке стратегии ранних фаз.
Опишите ваш опыт разработки планов раннего клинического развития (Early Development Clinical Plans). С какими основными вызовами вы сталкивались при переходе от доклинических исследований к фазе 1?
Оценка навыков взаимодействия с регуляторами.
Расскажите о вашем опыте подготовки ключевых регуляторных документов, таких как IB или протоколы исследований. Как вы обеспечиваете баланс между научной строгостью и требованиями регуляторов?
Проверка лидерских качеств и управления командой.
Как вы подходите к управлению кросс-функциональной командой (Clinical Ops, CMC, Regulatory) в условиях сжатых сроков и меняющихся приоритетов?
Оценка опыта в конкретной терапевтической области.
Учитывая фокус компании, какой опыт у вас есть в офтальмологии или смежных областях (дерматология, инфекционные заболевания)?
Проверка умения работать с данными.
Приведите пример ситуации, когда интерпретация клинических данных на раннем этапе привела к существенному изменению дизайна исследования или стратегии программы.
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- Страна
- США
- Зарплата
- 203 200 $ – 284 600 $