Director, Biometrics
- Employer
- 4D Molecular Therapeutics
- Location
- Emeryville, CA
- Start date
- Jun 23, 2021
View more
- Discipline
- Information Technology, Bioinformatics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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 Director of Biometrics will build and oversee the Biometrics organization with accountability for study designs, data analysis and interpretation of results in collaboration with partner functions in Development and Medical Affairs. The Director leads drug development strategy and assists with regulatory interactions. The Director of Biometrics will also interact with Health Authorities, as well as our partner contract research organizations (CRO). They will also provide biometrics consultations to cross functional teams as needed and will be responsible for recruiting, resourcing, and building infrastructure for Biometrics to support the 4DMT portfolio. This position reports to the Chief Medical Officer.
Responsibilities:
- Ensure overall effective operations in biostatistics, clinical data management, and clinical/statistical programming
- Oversee and lead two direct reports and Biometrics input in clinical development plans, clinical protocols, regulatory documents, publications, internal and external meetings and presentations
- Accountability for development, implementation and execution of statistical analysis plans that support clinical development plans and clinical protocols, and assures statistical integrity, adequacy and accuracy.
- Accountability for the consistency and accuracy of CRO data management and statistical programming deliverables, including derived data definition, analysis files structure, analysis methodologies, and analysis results
- Represent 4DMT Biometrics in Health Authority interactions as needed
- Develop and nurture key working relationships with internal partners including programmers and data managers as well as external vendors including investigators, research organizations, and thought leaders
- Continue to build and resource the Biometrics team, mentors and develops members of the Biometrics organization
- Establish best practices, identify the need and drive the creation of functional standard operating procedures for clinical data management, biostatistics, and statistical programming
- Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
Qualifications:
- Masters or Ph.D. in Biostatistics, Statistics or related program Experience:
- 5+ years in a leadership role with statistical programming experience in data collection, quality control and analysis within the Biotech or similar industry
- Must have operational leadership experience
- Gene therapy experience and/or rare disease therapeutic areas a plus but not required Skills:
- Good Clinical Practice (GCP) proficient
- Broad and extensive knowledge of theoretical and applied statistics
- Demonstrated understanding of Phase I – Phase IV drug development
- Comprehensive understanding of regulatory guidelines for drug development
- Expert in the principles and techniques of data analysis, interpretation and clinical relevance
- Expert level of proficiency with SAS and/or other statistical software packages
- Proven track record of fostering creativity, productivity, execution with a sense of urgency, teamwork, accountability, and cross-functional collaboration
- Entrepreneurial, self-starter with strong interpersonal and analytical skills, high ethical standards and proven ability to work effectively with cross-functional partners and other internal stakeholders
- Excellent external networking, relationship and presentation skills and a strong presence
- Must have operational leadership experience and management of direct reports Physical Requirements:
- Adhere to 4DMT COVID protocols and policy
- During the current COVID-19 pandemic, the ability to work remotely until it is safe to return to the worksite and work onsite once 4DMT deems it safe to return.
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.
- Website
- http://www.4dmoleculartherapeutics.com/
- Phone
- 510-505-2680
- Location
-
5858 Horton St. Suite 455
Emeryville
California
94608
United States
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