Director/Senior Manager, Clinical Development (Ophthalmology) – Top $$ (NC, NJ, CA)
Our client, a global leader in the development and commercialization of ophthalmic products, is actively recruiting for a highly skilled and knowledgeable candidate to lead clinical science/development efforts.
The company has several marketed products and a rich and expanding pipeline (glaucoma, retinal disease, ocular surface, others). This Director/Senior Manager (client is open to both levels) will lead cross-functional teams in the clinical development of Phase I – III assets. Seek candidate who brings both the scientific/clinical knowledge and the personal leadership skills to succeed. Compensation will be generous.
Key Things to Note:
- The company has operations in Research Triangle Park, NC, Irvine, CA and Bedminster, NJ, and they are targeting local candidates who can be on-site at one of these locations. Hybrid.
- This Director/Sr Manager will provide clinical leadership on program strategy, trial design, study execution, clinical study reports, regulatory submissions, etc. Seek Clinical Scientist with deep knowledge of drug development, regulatory requirements, and clinical best practices. Ophthalmology bkgd is required.
- This is a highly collaborative role. This Director/SM will act as Project Manager leading colleagues from Regulatory, CMC, Clin Ops, Toxicology, etc. in developing and executing clinical strategy. Seek Clinical Scientist with superb project leadership, communication and relationship-building skills.
- Position will involve extensive writing – including protocols, investigator brochures, clinical sections of regulatory documents, etc. Seek skilled, knowledgeable and savvy writer/editor.
- This company is in high growth mode. Policies, procedures and practices are being developed and/or enhanced to meet the needs of the future. Seek resourceful and focused candidate who will thrive in a building setting–someone who enjoys the pace and is excited to contribute to the growth. The future is exceedingly bright.
Position will involve collaborating with clinical leadership and cross-functional study teams to plan and execute clinical trials, with scientific integrity, from protocol concept through the clinical study report.
- Lead development of scientific components of assigned clinical trials and study-level leadership as a member and/or leader of cross-functional teams
- Author clinical study documents including protocols, procedure manuals, Investigator brochures, informed consent forms, medical monitoring plan, and others
- Support Clinical Operations in the activities associated with execution of clinical trials and data collection, including the selection of clinical investigators; training of the internal team, vendors, and site staff; preparation of case report forms; identification and prevention of protocol deviations; and resolution of issues
- Author clinical sections of Regulatory dossiers and briefing packages
- Review data listings to detect data trends and ensure data quality
- Engage in exploratory data analysis to identify trends and inform future research directions
- Monitor data to characterize safety information, in collaboration with the Medical Monitor
- Coordinate with Project Management to plan study timelines and track progress
- Contribute to external communication of clinical trial data
Targeted candidate will offer a PhD, PharmD, MD or OD with 5+ years of pharmaceutical drug development experience with particular strength in clinical research. Ophthalmology bkgd is strongly preferred.
Other priorities include:
- Knowledge of and experience in drug development process through all phases
- Knowledge and application of regulatory requirements and ICH guidelines
- Extensive clinical and regulatory writing experience
- Data science skills including application of statistical methods
- Excellent project management and project leadership skills
- Polished, thoughtful and persuasive communication skills
- Ability to lead in a matrixed environment including the ability to garner the respect and cooperation of a broad constituency of internal and external stakeholders
- Longevity, growth and impact in previous roles
Finally, we seek a forward-thinking quick study who will thrive in this emerging and collaborative setting; a smart, hands-on and resourceful critical thinker who get things done. The future is very bright. We seek a go-getter who will contribute and thrive.
Please forward Word resume for prompt consideration. Local candidates targeted (NC, NJ, CA)
Thank you so much. Enjoy the holiday weekend.