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Clinical Scientist

Employer
4D Molecular Therapeutics
Location
Emeryville, CA, United States
Start date
Sep 24, 2020

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Discipline
Clinical, Clinical Research
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Bay
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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 Scientist/Senior Clinical Scientist will play an integral role in facilitating successful and timely initiation and completion of 4DMTs clinical development programs working with members of Translational Medicine, Clinical Operations, Program Management, Clinical Research Organizations (CROs) and Investigators to plan, execute and monitor medical aspects of selected clinical trials. The successful candidate will operate in a highly detailed and organized fashion with the goal of efficiently driving each program through the clinical development process.

RESPONSIBILITIES:
  • Collaborate with the translational medicine teams on the design and implementation of clinical studies, the review and interpretation of study results, providing deliverables in approved time frames.
  • Analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
  • Lead or collaborate in the preparation of clinical study-related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
  • Engage with investigators, KOLs, SABs, as necessary
  • Engage with site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
  • Review and interpret scientific knowledge of competitor landscape (molecule/indication)
  • Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) including attendance at major scientific conferences.
  • Present clinical strategy and data to internal and external audiences (such as investigator meetings)
  • Provide support for business development activities, such as due diligence and research collaborations.
  • Maintains knowledge of ICH-GCP, external regulations and procedures


QUALIFICATIONS:
  • Education:
  • RN, MS, PhD or PharmD, or equivalent. Advanced degree candidates preferred


  • Experience:
  • Clinical science experience with 2+ years of drug development with experience in ophthalmology, cardiovascular disease, lung or neuroscience, preferred.
  • Expertise in clinical trial design, implementation, regulatory document preparation and statistics
  • Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data
  • Able to manage priorities and competing demands in a growing biotechnology company with a broad pipeline of products


  • Skills:
  • Excellent presentation skills for both internal and external audiences
  • Ability to balance independent work and team interaction
  • Well-developed interpersonal skills, and ability to build strong positive relationships
  • Good leadership and management skills to manage internal and external collaborations and work well within cross-disciplinary teams
  • Ability to travel, approximately 10%


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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