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Associate Director, Early-Stage Product Development
4 months ago
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.
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.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
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 VP, Early-Stage Product Development, the Associate Director will play an important role in early-stage drug product development programs from preclinical studies to clinical proof-of-concept.
RESPONSIBILITIES:
Contribute to the execution of early-stage drug product development programs through preclinical studies to clinical proof-of-concept Contribute to the assessment and prioritization of the 4DMT product pipeline. Work closely with the VP of Early-Stage Product Development, Therapeutic Area Heads and the Chief Research & Translational Development Officer to translate drug candidates into early phase clinical trials. Oversee the design and implementation of preclinical in vivo and in vitro studies, including IND-enabling studies. Lead cross-functional teams and work closely with the program management team to execute all product pipeline activities including IND-enabling studies. Contribute to the preparation of content for regulatory interactions and submissions (e.g. pre-IND and/or INTERACT meetings, IND filing, Orphan Drug Designation requests, EMA submission) as necessary. Continue to support late-stage product development serving as nonclinical subject matter experts and contributing to late-stage regulatory filings Present to and interact with senior management and Executive Team members to assess progress toward meeting strategic objectives and company goals, identify program risks, and develop risk mitigation plans. Present data and program updates internally and externally to scientific and non-scientific audiences. Other duties as assigned.
Education and Experience Requirements:
PhD in biological sciences required. 5+ years industry experience required 3+ years in project leadership or management role (lab science experience will also be considered) Experience working on a cross-functional team and developing strong cross-functional relationships Experience partnering with program management team to execute all product pipeline activities including IND-enabling studies Experience in preparation of content for regulatory interactions and submissions (e.g. pre-IND and/or INTERACT meetings, IND filing, Orphan Drug Designations requests, EMA submission)Required Skills/Abilities:
Strong scientific acumen and strategic thinking skills Proactive and flexible with changing work priorities Able to navigate ambiguity and able to take the initiative to define structure Excellent analytical, logical thinking, and problem-solving skills Excellent communication skills in both writing and presentations Ability to motivate groups of people to complete a project in a timely manner. Ability to work in a small company and fast-paced environment.
Base salary compensation range:
$189,000/yr - $215,000/yr
Please note that compensation varies depending on experience and other factors. 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
