Regional Vice President
Libra Solutions
Vice President, Clinical Development, Ophthalmology
4D Molecular Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $380,000 - $433,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Reporting to the Chief Medical Officer the VP Clinical Development, Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development.
- Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence throughout study execution.
- Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data review, while maintaining personal accountability for real-time monitoring activities and timely delivery of critical clinical trial outputs.
- Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
- Provide oversight and lead teams responsible for development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents and other regulatory submissions or documents as appropriate.
- Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
- Keep up to date with compliance, SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
- Provide medical leadership for internal audits and regulatory inspections.
- Assist in preparation of materials for Advisory Board meetings, BOD meetings, etc.
- Represent 4DMT and Lead interactions and collaborations with potential partners.
- Represent the Ophthalmology Therapeutic Area with key external stakeholders, including patients and patient advocacy groups, external experts, investors, and the ophthalmic and biotech business communities.
- Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Requirements
- M.D. Degree
- Clinical training in Ophthalmology
- Retina fellowship training a plus
- Board Certification (or equivalent)
- Minimum of 10 years of biopharma industry experience in drug development
- Phase 3 experience in retinal disease(s)
- Experience with NDA, BLA or MAA submission(s). Drug approval(s) a plus.
- Experience with gene therapy, other areas of Drug Development and commercialization is a plus.
- Strong interpersonal skills and high emotional coefficient
- Highly effective written and verbal communication skills
- Excellent analytical, problem-solving and strategic planning skills.
- Up to date understanding of the ophthalmic competitive landscape with a focus on retina
- Prior Clinical Trial experience in Retina
- Experience in participating or leading global regulatory interactions
- Ability to understand and translate complex data to key messages
- Ability to thrive in a fast-paced environment.
- Proven ability to prioritize effectively
- Proven ability to plan and conduct clinical trials ensuring high-quality trial execution and results within established timelines; demonstrated track record in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory)
- Track record of thinking strategically and executing to strategy
- Demonstrated success in influencing colleagues and senior leaders in various departments.
- Experience building and leading teams and driving engagement in a matrixed environment.
- Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
- Able to ensure accountability
- Able to manage conflict
- Comfortable managing ambiguity
- Strong clinical and scientific knowledge of ophthalmology (and retinal disease in particular)
- Track record of developing talent
- Record of cultivating and managing internal and external cross-functional collaborations.
- Demonstrates high integrity.
- Experience in successfully presenting and interacting with the Ophthalmic Retina Community and regulatory authorities in US, EU and APAC
- Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable.
Benefits
- Equal employment opportunities to all employees and applicants for employment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
M.D. DegreeClinical training in OphthalmologyRetina fellowship trainingBoard Certification10 years of biopharma industry experiencePhase 3 experience in retinal diseaseNDA submissionBLA submissionMAA submissionGene therapy experience
Soft skills
Interpersonal skillsWritten communication skillsVerbal communication skillsAnalytical skillsProblem-solving skillsStrategic planning skillsAbility to prioritizeAbility to manage conflictAttention to detailAbility to thrive in a fast-paced environment
Certifications
Board Certification
