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Associate Director, Program Management (Retina)

Employer
4D Molecular Therapeutics
Location
Emeryville, CA, United States
Start date
Feb 7, 2021

Job Details

4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining 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 competitive salary and benefits, and provides challenging opportunities for career development. 4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:

The Associate Director, Program Management, will be responsible for providing tactical and strategic program management working closely with the clinical leaders and one or more cross-functional clinical-stage program team(s). This role is specific for two clinical-staged ophthalmology programs that are currently in Phase 1 in the United States as well as partnered with Roche.

Ideal candidates will exhibit strength in communication and team leadership to succeed in a role that is highly cross-functional and broadly engaged across our rapidly growing organization. The ideal candidate will bring strong clinical-stage program management expertise and familiarity with the full drug development process and the ability to build and deploy tools and best practices to drive successful products to approval. The Associate Director will guide clinical-stage program(s) through key development milestones and decision points and will be responsible for managing the overall program timelines, budgets, and risks. The successful candidate will be a demonstrated leader with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective program management plans. The candidate must have the ability to work in a highly matrixed and cross-functional organization against tight deadlines. The role reports directly to the VP, Program Management Office (PMO).

Responsibilities:
  • Cross-functional Program Management_75% of time
  • Proactively manage and drive clinical programs to targeted milestones through cross-functional program team engagement
  • Partner with all members of cross-functional program team(s) to establish program goals, milestones, budget, and timelines
  • Communication and alignment with our Roche partner, including management of joint project team meetings, timelines, and program budget
  • Work closely with the 4DMT-Roche Alliance Manager to ensure program is within contractual obligations
  • Publish and communicate the program and risk status (e.g., goals, timelines, resources, budget, etc.) to the senior management
  • Track key program milestones and monitor interdependencies between functions
  • Manage stakeholders, including external partners and key collaborators
  • Manage changes to program plans, including but not limited to, proactive program impact/risk assessments prior to change implementation

  • Budget, Goals, and Upper Management Reporting_10% of time
  • Management of full program budget working with the PMO, finance and program team in yearly budget and update cycles
  • Management of quarterly pass-through and FTE cost reporting to external partner
  • Reporting of timelines and milestones, risks, and risk mitigation strategies to upper management

  • PMO Contribution_15% of time
  • Contribute to strategic PMO planning activities and participate as an active PM team member
  • Cross-collaboration and advisement with 4DMT Program Managers as additional programs approach clinic
  • Willingness to contribute time to other programs or working groups as bandwidth allows


Qualifications:
  • BS, MS, or PhD degree in an applicable field
  • Advanced degree in science or business preferred
  • PMP certification a plus

  • Experience:
  • 8+ years industry experience, including 5+ years in Program Management or related function
  • Track record of managing development programs through all clinical phases of development
  • Experience in cross-functional team management
  • Experience working with external partner
  • Experience in gene or cell therapy highly desired

  • Skills:
  • Strong communication skills and ability to lead and influence team members, peers, subject matter experts, and management
  • Strong organizational skills
  • A drive for mapping and executing the critical path toward key milestones
  • Ability to assess development paths and identify key risks and recommend options for creative mitigation strategies
  • Demonstration of strategic thinking and high-level planning
  • Ability to foster the qualities of a high-performing team
  • MS Project application experience or equivalent (Clarizen, etc.)
  • Strong interpersonal skills and professional demeanor and ability to communicate in person and virtually

  • Physical Requirements:
  • Adhere to 4DMT COVID protocols and policy


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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