Shape Therapeutics is a biotechnology company developing next-generation RNA-targeted therapies to treat the world’s most challenging diseases. The ShapeTX technology platform includes RNAskip™, a proprietary suppressor tRNA technology that enables premature stop codon readthrough; RNAfixTM, a precision RNA editing technology using endogenous Adenosine Deaminase Acting on RNA (ADAR); and AAVidTM, a next-generation engineered adeno-associated virus (AAV) platform producing highly specific, tissue-tropic AAVs. The power of the ShapeTX platforms resides in redirecting the cellular machinery already present in our cells, thereby bypassing the risks of immunogenicity and DNA damage seen with other contemporary editing technologies. 

At ShapeTX, we are a dynamic team of professionals who are dedicated and passionate about making cures a reality. Through diversity of thought, scientific knowledge, professional rigor and focus we are merging cutting-edge science with extensive drug development expertise to unlock cures to many debilitating diseases. Shape Therapeutics is headquartered in Seattle, Washington with a satellite site in Cambridge, Massachusetts.

ShapeTX is looking for a Sr. Director / Vice President, Clinical Development to advance a pipeline of next-generation RNA-targeted therapies from IND through clinical proof-of-concept to registration. In this role, reporting to the CEO, the successful candidate will lead development of the clinical strategy, trial design and execution.  The candidate will work closely with research, program management, regulatory affairs, clinical operations, biostatistics, data management and medical writing to advance ShapeTX’s clinical programs. This physician scientist will play a key leadership role, as ShapeTX continues to evolve into a clinical stage biotech.

 

Roles and Responsibilities:

  • Develop the clinical development strategy for ShapeTX’s lead research candidate(s)
  • Assist in building and recruiting talent for the clinical development organization
  • Liaise with external stakeholders
  • Represent the clinical program on program/project teams and to senior management, business partners and regulatory agencies
  • Lead the planning, design, and implementation of clinical trials across all phases; Manage the medical monitoring of sites and trials
  • Partner with Translational Research on biomarker selection, pharmacodynamic endpoints, and patient stratification considerations
  • Provide pharmacovigilance oversight and manage timely reporting of safety signals to regulatory agencies
  • Guide Research team on decisions that have clinical components and implications
  • Maintain accountability for all clinical development timelines and deliverables
  • Manage the writing of protocols, presentations, and publications (regulatory submissions, original peer-reviewed articles, abstracts)
  • Review key documents including protocols, investigator brochures, and informed consent forms
  • Partner with Clinical Operations on the selection and implementation of in-house versus outsourced approaches for various Clinical Development capabilities
  • Maintain the highest quality clinical programs, following GCP and ICH guidelines
  • Help guide overall company strategy and trajectory as part of leadership team
  • Provide leadership and mentorship to clinical development team members

Requirements:

  • MD or MD/PhD with 10+ years of industry experience
  • Experience in a rapidly growing biotech company is preferred
  • Background in gene therapy, rare disease and/or neurology preferred

Skills and Experience:

  • Proven track record of drug development with Phase 1 through 4 trial experience preferred
  • Outstanding communication and leadership skills accompanied by a readiness to “roll up the sleeves” to contribute to team efforts
  • Excellent writing skills evidenced by publications and polished presentations to influence internal and external audiences
  • Ability to develop creative approaches to processes, practices, services, business models, and strategy
  • Takes personal accountability for outcomes and thrives on increasing levels of responsibility to move the business forward
  • Robust regulatory experience with Pre-INDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US
  • Experience having managed significant accelerations and challenges in clinical programs

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