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4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL SUMMARY:
Reporting to the Sr. Vice President, Ophthalmology Therapeutic Area Head the VP Late Stage Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Late Stage Drug Development Phase.
We seek an experienced physician to play a critical role in the build out and leading of the late stage Clinical Development Organization at 4DMT as we spearhead the introduction of the first intravitreally delivered genetic medicines for the treatment of the most common causes of irreversible blindness. The successful candidate will lead the late stage clinical development strategy and execution and clinical trial in late stage. A candidate for this role should also feel confident to attract and develop talent in their part of the organization as indications and the trial portfolio grow. The VP, Clinical Development will be the primary point person for medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, medical monitoring, review and interpretation of clinical trial data, drafting key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.
RESPONSIBILITIES:
- Lead the development of the Late Stage Ophthalmology Therapeutic Area Strategy in collaboration with cross functional partners (including but not limited to Commercial, CMC, Regulatory, and Early Research)
- Implement Ophthalmology TA Strategy through phase 3 and ph 4 studies in the clinical development plans
- Lead and manage a team of physicians and clinical scientists to design and execute the late stage clinical trials across the designated ophthalmic diseases in alignment with the Ophthalmology TA strategy.
- Provide Clinical Scientific Leadership to the study teams
- Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
- Collaborate as appropriate with early research and other functions as appropriate to identify potential new targets for development in the treatment of ophthalmic diseases, which may include and not limited to due diligences and other strategic opportunities as needed
- Provide oversight and lead late stage 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 with pharmacovigilance in the analysis of clinical trial safety data.
- Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
- Lead the design and writing of clinical protocols and associated clinical documents contribute as an author with the writing of abstracts, posters and/or meeting presentations
- 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
- Identify and stablish collaborations where appropriate with clinicians in the Ophthalmology community
- 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
- Travel Domestic and Internationally as required 20%
QUALIFICATIONS:
Education:
- MD
- Clinical training in Ophthalmology
- Retina fellowship training a plus
- Board Certification (or equivalent)
Experience:
- Minimum of 8 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
Skills:
- 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 Late Stage 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.
Base salary compensation range: $354,000 - $447,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities