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Sr. Director, Development Project Team Lead

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Feb 13, 2024

Job Details

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.

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 Chief Medical Officer, the Sr. 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.

In this role you will lead cross-functional teams through the development of novel therapeutics across multiple therapeutic areas to ensure successful global development and commercialization.

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 research, clinical science, clinical development/operations, patient advocacy, medical affairs, safety, regulatory, commercial and product development and manufacturing). The PTL will also collaborate with various stakeholders in investor relations, business development and product portfolio planning to align the strategy and operational plan with the overall organizational strategy. 

*Late phase drug development experience required*

RESPONSIBILITIES: 

  • Function as a single point of accountability at 4DMT for all aspects of a medicine in development globally from early clinical development 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.
  • Partner with PM to effectively execute 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.
  • Leads interactions and collaborations with potential partners.

QUALIFICATIONS: 

Education: 

  • Life sciences doctoral degree preferred (M.D., Ph.D., or PharmD) but Master’s degree with significant relevant experience acceptable

Experience: 

  • A minimum of 12+ years of biopharma industry experience in drug development including at least 5 years project team leader experience ideally in late phase drug development.
  • Experience leading cross-functional drug development teams through preclinical and clinical phases, focused on the development of novel therapeutics across multiple therapeutic areas and modalities, to ensure successful global development and commercialization.
  • 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
  • Preference for life sciences doctoral degree preferred (M.D., Ph.D., or PharmD) and/or relevant industry experience acceptable

 

Skills: 

  • 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.

National salary compensation range: $248,000/yr - $291,000/yr

Bay Area salary compensation range: $264,000/yr - $311,000/yr

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

Company

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.


At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.


While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.


At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.


4D Purpose Statement:  Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients


GUIDING PRINCIPLES

 

  • Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
  • Break Boundaries - Question the status quo and innovate beyond conventional approaches
  • Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
  • Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans


We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development. 
 

Company info
Website
Phone
510-505-2680
Location
5858 Horton St. Suite 455
Emeryville
California
94608
United States

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