Senior Director and Head of Biometrics
Proteostasis Therapeutics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of novel therapeutics that treat diseases caused by an imbalance in the proteostasis network, a set of pathways that control protein biosynthesis, folding, trafficking and clearance. Our initial therapeutic focus is on cystic fibrosis, or CF, which is caused by defects in the cystic fibrosis transmembrane conductance regulator, or CFTR, protein and insufficient CFTR protein function. CF is an orphan disease that affects an estimated 70,000 to 100,000 patients worldwide, with the vast majority of affected individuals in the United States, Canada, Europe and Australia. CF is the most common fatal inherited disease in Caucasians, and there is presently no cure.
We seek to hire talented people and to create an environment that facilitates continued professional growth. The extensive and ongoing work with our founders and collaborators adds an outward-looking, collaborative aspect to the company’s culture. This blend of internal and external talent, combined with cutting-edge science and an innovative business model, make Proteostasis Therapeutics an exceptional place to work.
Position Title: Senior Director and Head of Biometrics
Reporting to the Chief Medical Officer, the successful Biometrics candidate will serve an overarching role to position Biostatistics and Statistical Programming as a well-coordinated and innovative function at PTI, ensuring strategic planning and close cross-functional communication to drive programs forward.
Duties and Responsibilities:
- Establish and lead a high-performance biometrics team to support clinical development and translational medicine activities with a focus on quality and excellence
- Oversee biometrics activities including strategy, program support, personnel oversight, best practices, compliance, timely study deliverables and application of emerging science
- Assure that biometrics activities comply with health authority regulations
- Lead or support technology-based initiatives to support clinical development with data visualization tools or other technologies
- Apply innovative approaches to study design, analysis, data modelling and exploration, and presentation methodologies from phase 1 to registration studies
- Leads development of biometrics department SOPs and best working practice guides
- Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors
- Author relevant sections of regulatory submissions and represent PTI at regulatory agencies, and participates in writing, review and finalization of abstracts and manuscripts for publication
- Represent PTI on data safety monitoring boards to oversee clinical studies
- Develop and retain key talent by managing and mentoring biostatisticians, programmers, data managers and other personnel as needed to grow a cohesive unit
- Anticipate and communicate the project level and the study level resource and quality issues that may impact deliverables or timelines, propose and implement solutions, escalate issues to management as appropriate
- Ensure development and implementation of departmental standards and process improvements
- Work collaboratively with other quantitative disciplines including clinical pharmacology, translation medicine/biomarkers, and computational biology/bioinformatics to support clinical development
Qualifications and Skills:
- Minimum of 10 years of experience in pharma or biotech
- Strong methodological technical and analytical expertise, with leadership experience in both early and late development contributing to governance milestones, strategy, health authority interactions, protocols and submissions
- Proven track record of effective leadership experience including managing reports, teams, taskforces or initiatives
- Proven knowledge and expertise in statistics, statistical programming and data management, and its applications to clinical trials
- Knowledge of FDA, EMA, ICH guidelines and regulations related to clinical trials, statistics and data handling
- Prior registration and NDA/BLA experience
- Sound knowledge of clinical database management, statistical programming languages (including SAS), software.
- Excellent communication and presentation skills
- Experience with translational data analysis preferred
- Experience in managing biostatistics, statistical programming and data management preferred
- Experience with outsourcing biometrics activities, and in overseeing services provided by CROs and contractors preferred
- Team player, with ability to work successfully across functions
Candidates must be authorized to work in the U.S. and live locally only – we will not support relocation for this position. Applicants should send a resume and cover letter to: Director of Human Resources at email@example.com.