Clinical Scientist Ophtalmology
The Clinical Scientist (Ophthalmology) will report directly to the Chief Development Officer (CDO) and play a pivotal role in advancing Oculis’ ophthalmology portfolio through leading cross functional development Teams. This role requires a deep understanding of clinical development to provide appropriate guidance in protocol design and study oversight through data review and monitoring.
Reports To: Clinical Scientist Ophthalmology
Function: Research and Development
Level: Senior Director/Executive Director
Location: Boston, MA
The role works closely with the CDO and other members of the cross-functional development and study teams including the areas of Regulatory Affairs, Pharmacovigilance/ Safety, Biometrics/ data management, Clinical Pharmacology, Medical Affairs, Nonclinical and translational sciences, and Clinical Operations to successfully implement the clinical program; and support advancement of Oculis development programs through the product life-cycle from inception to commercialization.
The ideal candidate has a doctorate degree (MD, PhD, OD, or PharmD), strong scientific background and leadership capabilities and a passion to further advance the Oculis ophthalmology pipeline. (ophthalmology clinical development experience required; ophthalmologist preferred).
Key Responsibilities
1. Strategic Direction:
- Define and execute the clinical development strategy for ophthalmology programs
- Team leader of assigned cross Functional Development Teams responsible to execute strategic and operational development team goals aligned with corporate objectives.
- Identify opportunities for growth and innovation within the ophthalmology field
2. Operational Excellence:
- Lead data monitoring strategy and oversee data monitoring in clinical trials, ensuring adherence to protocols, timelines, and quality standards
- Manage relationships with external vendors, investigators, and clinical sites
- Monitor safety in assigned clinical studies
- Contribute to data cleaning and data review
- Contribute to the design, analysis, interpretation, and reporting of scientific content of protocols, Investigators Brochures, Clinical Study Reports, and regulatory filings and responses
- Coordinates appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects
- Cultivates relationships with opinion leaders and technical experts related to the molecule and disease area to ensure broad perspectives across multiple disciplines are incorporated into Clinical Development Plans and protocols
- Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area
- Understands the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research
3. Areas of Focus:
- Retinal diseases: Lead clinical trials related to retinal disorders, including age-related macular degeneration, diabetic retinopathy and macular edema, glaucoma, optic neuritis and other neurodegenerative ocular diseases
Necessary Skill Set
- Medical Expertise: Board-certified ophthalmologist or advanced degree (MD, OD, PhD, Pharm D, etc) with extensive clinical development experience in ophthalmology
- Scientific Acumen: Strong understanding of ophthalmic diseases, treatments, and diagnostics; Knowledge of clinical trial methodology, regulatory and compliance requirements that govern clinical trials
- Leadership: Ability to lead cross-functional teams and drive clinical programs; Strong leadership competencies in building relationships with peers and partners, holding high standards and supporting others in achieving results, creating an environment of learning and, when necessary, failing fearlessly, and embracing diversity in all forms
- Communication: Excellent verbal and written communication skills
- Problem-Solving: Proactive approach to addressing challenges in clinical development
Qualifications
- MD or MD/PhD degree with specialization in ophthalmology preferred but not mandatory
- Minimum of 10 years’ experience in clinical research or drug development
- Track record of successful clinical trial management
- Familiarity with regulatory guidelines and industry best practices
This job may require travel up to 20% of the time, depending on the location and status of ongoing clinical studies.
Oculis SA is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply.