Director, Clinical Data and Biometrics

Location
Emeryville, CA
Posted
Apr 24, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 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 
  • Until it is deemed safe to return to our Emeryville worksite, this role will be remotely based. 

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