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Head of Clinical Science
2 months ago
Progenics Pharmaceutical Inc. is a leader in the field of medical imaging, dedicated to enhancing patient care through innovative diagnostics and therapeutics. We are committed to fostering a collaborative and inclusive environment where every employee plays a vital role in our success.
The Director of Clinical Science will oversee the design and analysis of clinical studies, ensuring that our investigational products progress effectively through various stages of development. This role requires a strategic thinker who can navigate a complex, cross-functional environment and work closely with diverse teams.
Key Responsibilities
- Ensure the relevance and precision of clinical science planning and guidance for studies, translating strategic objectives into actionable clinical protocols and documentation.
- Lead the creation and review of essential product and study-related documents, including Clinical Protocols, Investigator Brochures, and Clinical Study Reports.
- Oversee the execution of clinical studies in collaboration with Clinical Operations and other internal and external stakeholders.
- Engage with investigative sites to address protocol-related inquiries and resolve study conduct challenges.
- Review clinical data to ensure compliance with protocols and strategic goals.
- Prepare and present clinical data and protocol designs at various meetings and advisory boards.
- Collaborate with stakeholders to gather scientific and clinical insights necessary for effective clinical development.
- Support regulatory interactions and contribute to the development of clinical sections for regulatory submissions.
- Participate in the review and management of safety reports and database reconciliations.
- Assist project teams in conducting clinical studies, including trial registration and results reporting.
- Foster relationships with Key Opinion Leaders and external experts to enhance clinical trial objectives.
- Lead the preparation of advisory board meetings and development of clinical publications.
- Stay informed on clinical developments by attending scientific meetings and engaging with investigators.
- Promote safety awareness and adhere to safety practices in all aspects of work.
Qualifications
- Advanced degree (e.g., MS, PhD, or PharmD) preferred.
- 7 - 10 years of experience in clinical development within the pharmaceutical industry.
- Experience in oncology and neuroscience medical imaging or radiopharmaceutical development is advantageous.
- Proven ability to work collaboratively with investigators and external partners.
- Strong understanding of regulatory guidelines and ICH/GCP.
- Excellent communication skills, both verbal and written, with the ability to navigate a multifunctional environment.
Core Values
The ideal candidate will embody Progenics' core values:
- Empower individuals to excel.
- Foster mutual respect and teamwork.
- Embrace learning and adaptability.
- Prioritize patient health and safety.
- Take ownership of solutions and drive results.
Progenics Pharmaceutical Inc. is an equal opportunity employer, committed to diversity and inclusion in the workplace.
