Director Of Clinical Development, Oncology

3-5 years

$240,000.00 - $360,000.00

Philadelphia

10 April 16, 2025

Job Description

Job Type: Full Time Education: MD/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director of Clinical Development, Oncology
Location: Philadelphia, PA -- [Remote/Home-Based]
Req ID: R009522
Category: Research & Development

Company Overview:
Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases, often with limited or no therapeutic options. Jazz has a diverse portfolio, including therapies for sleep disorders, epilepsy, and a growing portfolio of oncology treatments. The company’s patient-focused and science-driven approach supports pioneering research and development in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland, with operations across multiple countries to serve patients worldwide.

Position Overview:
Jazz Pharmaceuticals is seeking a clinical development physician to join the hematology oncology drug development team. The Director will be responsible for the development of clinical studies, oversight of clinical trials data, clinical interactions with various internal departments, and external stakeholders such as regulatory agencies and thought leaders. The Director will drive the strategy, development, and execution of clinical studies for investigational medicines and new indications for approved medicines.

Key Responsibilities:

Clinical Strategy and Development:
- Devise strategies for and develop clinical studies for investigational medicines and new indications.
- Work closely with functional areas such as clinical operations, data management, biostatistics, clinical pharmacology, and preclinical to facilitate clinical trial execution.
- Develop regulatory strategies in response to regulatory guidelines and competitive intelligence.
Clinical Trial Management and Reporting:
- Provide clinical/scientific input during trial development and execution.
- Interpret clinical trial data, prepare reports, regulatory submissions, and publications.
- Monitor clinical trials for safety and work with Product Safety to report safety signals to regulatory authorities.
Regulatory Engagement:
- Lead preparation of clinical portions of regulatory filings (IND, NDA, MAA).
- Serve as the lead medical representative with regulatory agencies.
- Interact with key opinion leaders and academic organizations to integrate the latest clinical thinking into development plans.
Advisory and Leadership:
- Lead clinical and patient advisory board meetings to obtain strategic input.
- Provide clinical expertise for licensing opportunities and serve as a resource for internal and external collaborators.
- Contribute to clinical program development with input from internal and external stakeholders.
Cross-functional Collaboration:
- Work effectively in cross-functional teams, managing multiple complex projects simultaneously.
- Foster collaborative partnerships both internally and externally.

Required Knowledge, Skills, and Abilities:

Extensive experience in scientific and therapeutic aspects of oncology.
Excellent written and verbal communication skills, with proven experience in an international collaborative environment.
Experience in leading clinical study design, conduct, analysis, and reporting.
Ability to work proactively and creatively in problem-solving and decision-making.
Track record of relevant scientific publications.

Required/Preferred Education and Licenses:

MD or MD, PhD or equivalent with 3-5 years of relevant experience in oncology.
Board certification in Oncology.

Additional Information:
Jazz Pharmaceuticals values leadership and collaboration. Our people managers are vital in creating an environment where teams thrive and individuals reach their full potential. Jazz invests in its people managers to ensure they are equipped to drive performance and foster a culture of inclusion.

Compensation:
Base pay range: $240,000.00 - $360,000.00, with additional discretionary bonuses or incentives. Compensation depends on qualifications, skills, and experience.

The successful candidate will also be eligible for a comprehensive benefits package, including medical, dental, and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more details, visit Jazz Benefits.

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Director Of Clinical Development, Oncology

Job Description

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