Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.
Director, Regulatory CMC
Location
United States
Posted
2 days ago
Salary
$220K - $250K / year
Seniority
Lead
Job Description
Director, Regulatory CMC
Iovance Biotherapeutics, Inc.
• Works closely with functional leaders to create the optimal development path for Iovance product candidates, negotiate optimal development paths within internal cross-functional teams and with health authorities, execute clinical-regulatory development plans on-time and while managing all identified risks. • Plans, manages, and creates Clinical Trial Applications, Market Applications and amendments. • Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy. • Leads cross-functional teams in preparing for health authority meetings. • Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making. • Works within the department and with other functional areas on process improvements. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.
Job Requirements
- BS degree in life sciences.
- Minimum 10 years’ experience in regulatory affairs
- Late-stage experience in oncology drug development.
- Experienced in creating and negotiating the clinical-regulatory aspects of oncology programs.
- Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents. E.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries.
- Able to write clearly and concisely, within agreed timelines.
- Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences.
- High attention to detail and accuracy.
- High organizational and planning skills.
- Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
- Excellent interpersonal, verbal and written communication skills
Benefits
- Reasonable accommodations may be made upon request to enable individuals to perform essential functions
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