Your experience includes…
- MD/PhD or equivalent degree with relevant internal medicine training and board certification +15 years of industry experience in clinical development within a pharmaceutical or biotechnology company.
- Designing, implementing, and overseeing multiple early-stage clinical studies, including study start-up activities, medical monitoring and productive partnership with study investigators and clinical research organization staff.
- Authoring documents required for clinical studies, including study protocols, investigator brochures, regulatory briefing packages and dossiers to support IND/CTA/CTN. You must have direct experience with IND/CTA submissions.
- Thorough understanding of ICH and GCP guidelines to ensure the appropriate conduct of global clinical studies.
- Understanding of clinical research methodology and biostatistics principles.
- Demonstrated track record of overseeing a clinical team and successfully completing clinical studies.
- Effective communication and presentation skills.
You are interested in…
- Providing clinical leadership and medical representation for the liver Gene WritingTM programs, serving as primary medical lead/expert and medical monitor for clinical studies.
- Ensuring a streamlined and innovative clinical development and medical strategy by developing expertise in relevant therapeutics areas and staying current with advances in the field. This includes soliciting and incorporating input from academic thought leads, research leads, regulatory authorities and CRO's.
- Authoring medical components for clinical development plans, study protocols, investigator brochures, informed consents, SAPs, pharmacy manuals and associated clinical/regulatory documents including clinical study reports, regulatory briefing books and submissions, responses to questions from regulators, IRBs/ECs, and medical content for other relevant internal/external documents.
- Hiring, developing and managing clinical development resources in accordance with program budget and timelines.
- Overseeing risk-based safety monitoring of clinical studies, including regular review of safety data. Developing appropriate responses to safety issues that might arise.
- Interpretation and analysis of clinical study safety and efficacy data, as well as reviewing nonclinical toxicology studies.
- Preparation of meeting abstracts, posters, presentations, and publications for internal management review and external scientific/clinical meetings.
- Maintaining a constant focus on patient wellbeing across the organization.
About you:
You are an industry experienced physician trained in internal medicine who is interested in leading Clinical Development of Tessera's non-viral lipid nanoparticle (LNP) delivery and Gene WritingTM genome editing platforms to correct pathogenic mutations in the liver. You have experience with strategic oversight, hands-on management and advancement of innovative clinical stage programs.
You encompass skill and drive to be hands on and are interested in building a team from the ground up. You have the ability to create strong collaborations across leadership and key stakeholders while representing the medical perspective for Tessera's programs both internally and externally.
Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization and themselves.
Leadership Structure:
This position reports to: Dave Davidson - Chief Medical Officer
David joined Tessera in 2021 as Chief Medical and Development Officer. David brings over 20 years of expertise in clinical drug development focused on rare diseases and gene therapy.
Most recently, David served as Chief Medical Officer of bluebird bio for nearly a decade, where he played a critical role in advancing a broad genetic medicine pipeline across blood disorders, rare diseases and oncology, successfully leading numerous genetic medicine programs into the clinic and delivering two first-in-class approvals for genetic medicines in the U.S. and Europe. Prior to bluebird bio, David led clinical research for a wide range of therapeutic programs at Genzyme and GelTex, spanning biologics, polymers, and gene therapy.
David completed a fellowship in infectious diseases at the Harvard Longwood Combined ID Program, his residency training in internal medicine and an endocrinology research fellowship at the University of Chicago Hospitals, and received his M.D. from New York University and B.A. from Columbia University.
Company Summary:
Tessera Therapeutics is pioneering Gene Writing— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
