Associate Director/Director, Clinical Science

Job Title: Associate Director/Director, Clinical Science

About Us:

Our Stealth Newco is a biotechnology company developing differentiated, impactful therapeutics for the treatment of serious, common ophthalmic diseases. Our approach is to identify, acquire and develop these therapeutic programs with the highest levels of quality, scientific rigor, and transparency. We are targeting biologies that we believe will make meaningful improvements to patient care and treatment outcomes, and we will prospectively utilize the latest technologies in ophthalmic imaging and data sciences to inform our drug development activities.

Working With Us:

Drug development is always a challenging endeavor. We believe that one of the best things we can do for the patients we aim to serve is to foster a supportive, safe, and motivating environment for our team members. To us, this means empowering individuals at all levels of the organization to make smart, informed decisions, creating a safe environment for team members to share their ideas and express their concerns, and encouraging transparent communication about the challenges faced and overcome daily and the impact the team has on the opportunities entrusted to us.

As an early employee in this company, you will help build an ophthalmology-focused, clinical-stage biotechnology company as part of a highly experienced team. You will have opportunities to take on various roles and responsibilities in an environment that supports and celebrates your professional growth.

We are currently operating as a virtual company.  This role is  based in the continental US. Employees will be expected to attend in-person workplace gatherings at a common location once to twice per quarter as the company grows.  This position will require some travel up to 20% for external meetings and support of clinical trials and regulatory activities as needed.

Key Responsibilities:

This role will reports to the VP of Clinical Development, and will work closely with the leadership team.  Responsibilities include:

1. Clinical Strategy and Leadership:
   • Help develop and implement clinical development strategies aligned with company goals and regulatory requirements.
   • Collaborate with cross-functional teams, including clinical operations, regulatory, and CRO/external vendors, to drive and execute clinical development initiatives.
   • Develop and maintain strong relationships with regulatory agencies, key opinion leaders, and industry partners.
2. Clinical Trial Planning, Execution, and Oversight:
   • Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations.
   • Contribute to the identification, formulation and implementation of amendments to the clinical protocol in collaboration with Director of clinical development
   • Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, Informed Consent Forms, safety updates and submission dossiers.
   • Support pharmacovigilance activities (e.g. contributing to reports, patient narratives, etc.)
   • Produce training materials, share best practices and provide training to the broader clinical trial teams.
   • Support preparation and participate in study level meetings (e.g.  Investigator Meetings, Data Monitoring Committee meetings, etc.)
   • Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study. This will also include support for Case Report Form (CRF) development, and implementation of data capture tools.
   • Vetting and implementation of innovative data capture and data analysis tools to both expand and make more efficient the interpretation of study data.
   • Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis.
   • Support and lead crucial data collection and study activities including Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle.
   • Work to improve the quality of reviews/ insights with an emphasis on subject safety, data integrity, trend identification, innovative data review methodology, and identification of cases for medical review.
   • Ensure compliance with Good Clinical Practice (GCP), regulatory guidelines, and ethical standards.
   • Monitor trial progress, identify and mitigate risks, and ensure timely completion of milestones.
3. Scientific Communication and Collaboration:
   • Present clinical data and strategic plans to internal and external stakeholders, including investors, regulatory bodies, and scientific communities.
   • Publish research findings in peer-reviewed journals and present at scientific conferences.
   • Foster collaborations with academic institutions, research organizations, and industry partners to advance clinical programs.
4. Regulatory Affairs:
   • Support regulatory activities, (e.g.) preparation of and participation in meetings with regulatory agencies.
   • Participate in preparation and submission of regulatory documents (INDs, NDAs, BLAs).
   • Ensure adherence to regulatory requirements and maintain up-to-date knowledge of industry trends and regulatory changes.

Successful Candidates Will Meet Most of These Criteria:

• PhD, MD, PharmD or equivalent degree in Ophthalmology, Clinical Science, or a related field.
• Minimum of 6 years of experience in clinical research and development, with a focus on ophthalmology.
• Proven track record of successful clinical trial design, execution, and regulatory submissions.
• Strong communication, presentation, analytic and strategic capabilities and ability to effectively collaborate with medical experts.
• Strong familiarity with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3.
• Strong knowledge of FDA regulations and ICH guidelines.
• Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting.
• Strategic thinker with a passion for innovation and patient-centered care.
• High flexibility and adaptive working style, ability to work on several tasks at the same time.
• Ability to work effectively under high time pressure, while maintaining high quality standards.
• Prior experience operating in a dynamic small biotech company environment preferred.
• Ability to effectively prioritize tasks, and implement accordingly.
• High proficiency in English (written and spoken).
• Proven ability to work independently and in a team setting is essential. High level of autonomy and motivation.

Expected salary range:

• The base pay range for this position is expected to be $180,000 - $235,000 annually
• Base pay offered may vary depending on job-related knowledge, skills, capabilities, and experience
• The total compensation package for this position also includes equity, bonus, and benefits
• The position will be remote, based in the United States.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.