Sr. Director, Development Project Team Lead
4D Molecular Therapeutics
At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.
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.
• 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
Reporting to the Chief Medical Officer, the Senior Director, Project Team Leader-Development (PTL-D) provides strategic leadership for the optimal global development of a medicine, acting as the single point of accountability to deliver differentiated medicines of value.
By collaborating with the various stakeholders across R&D and Pharma, the PTL-D defines the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy.
The PTL leads a medicine cross function team (XFT), which has responsibility for representing all the various R&D and commercial disciplines required to optimally deliver the development of a medicine (including clinical development, medical affairs, safety, regulatory, commercial and product development and manufacturing).
- Function as a single point of accountability at 4DMT for all aspects of a medicine in development globally from Phase 2 through approval in first major markets
- Partners with the Therapeutic Area Head to ensure alignment with the Therapeutic Area Strategy, taking the competitive landscape into account. Translates 4DMT’s strategy into a medicine strategy and actionable plans for multiple areas or functions.
- Delivers differentiated medicines of value for patients, stakeholders, and markets, through an evidence package that supports regulatory approval, market access, and product life cycle.
- Oversees the Target Product Profile (TPP), ensuring alignment with disease area strategy, evolving clinical and standard-of-care landscape, competition, and commercialization.
- Creates strategic and integrated late-stage product development plans which are aligned with the TPP, business objectives and are differentiated from competitor products.
- Leads and communicates the product development strategy at governance meetings, accountable for aligning with internal management and for communicating with external stakeholders including partners.
- Leads the XFT to effectively manage/mitigate/communicate risk, make decisions, and manage conflict and change.
- Accountable for the execution of the integrated product development plan to agreed scope, timelines, and budgets.
- Responsible for all aspects of late-stage product development strategy including registrational clinical development, patient selection, regulatory interactions and approval strategy, intellectual property, and CMC.
- Prioritizes and maximizes the assets portfolio options including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points
- Leads interactions and collaborations with potential partners.
- Life sciences doctoral degree preferred (M.D., Ph.D., or PharmD) but Master’s degree with significant relevant experience acceptable
- A minimum of 10 years of biopharma industry experience in drug development including at least 3 years project team leader experience in late phase drug development.
- Experience with NDA, BLA or MAA submissions. Drug approval(s) a plus.
- Experience with gene therapy and commercialization experience a plus
- Experience in pulmonology or ophthalmology drug development a plus
- Demonstrated ability to think strategically
- Demonstrated experience leading and motivating teams in a highly matrixed environment.
- Proven record of cultivating and managing internal and external cross-functional collaborations.
- Demonstrated success in influencing colleagues and senior leaders in various departments.
- Must demonstrate high integrity.
- Effective written and verbal communication skills
- Strong knowledge and understanding of the given therapeutic area with experience in diverse biological mechanisms and broad understanding of the evolving clinical landscape in the given therapeutic area preferred.
Bay Area base salary compensation range is $264,000 - $306,000
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.