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Sr. Project Manager, Clinical

Employer
4D Molecular Therapeutics
Location
Emeryville, CA, United States
Start date
Aug 27, 2020

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

4D Molecular Therapeutics (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.

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 uniquely generous benefits, and provides challenging opportunities for career development. Join us in creating the ultimate gene therapy products to cure genetic diseases in children and adults. 4D Molecular Therapeutics, located in Emeryville, CA.

GENERAL SUMMARY:

The Clinical Project Manager (CPM) will manage the cross-functional project team working in close collaboration with the medical team accountable for the trial. The CPM will interface with clin ops, clin sci, regulatory, CMC, the CMO and trial medical director. The CPM will ensure full collaboration and communication needs are met across all the functions. The CPM will drive the timelines to meet corporate milestones and identify risks and ensure risk mitigation steps are taken. The role reports directly to the VP, Program Management and is a member of the PM team.

RESPONSIBILITIES:
  • Cross functional Management: 40% of TIME
  • Work cross-functionally to ensure all clinical trial needs are met on time
  • Set up cross-functional Gantts and trackers; keep updated regularly
  • Risk identification and mitigation management


  • Timeline: 25% of TIME
  • Ensure action items are met and keep the team aware of deadlines
  • Mapping out timelines and working with teams to ensure trial needs are on track


  • PM Team: 20% of TIME
  • Work in a close partnership with the project leader while also being a key member of the PM team
  • Be able to navigate a fast-paced biotech environment and drive a program, keep key stakeholders updated, and flag potential problems or risks
  • Identification and implementation of new process needs


  • Budget: 15% of TIME
  • Monitor cross-functional program budgets
  • Gather Quotes and set up PO's
  • Vendor Management


QUALIFICATIONS:
  • Education:
  • BS, MS, or PhD in a biological science
  • PMP Certification a plus


  • Experience:
  • 5+ years of project management experience in biotech
  • Previous experience in Phase I - II clinical stage project management


  • Skills:
  • Strong organizational skills
  • Experience in cross-functional team management
  • Gene therapy and/or rare disease experience a plus
  • Experience using programs to develop Gantt charts, ideally MS Project
  • Strong interpersonal skills and professional demeanor and ability to communicate in person and virtually


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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