Manager/Senior Manager, Preclinical Development Operations
Rubius Therapeutics
 Cambridge, MA
Rubius Therapeutics is a rapidly-growing, clinical-stage biopharmaceutical company that is genetically engineering red blood cells into an entirely new class of allogeneic, off-the-shelf cellular medicines.  Our Red Cell Therapeutics™ (RCTs) can potentially be used to replace missing enzymes for patients living with rare enzyme deficiencies, kill tumors in cancer and regulate the immune system for the treatment of autoimmune diseases.  Our first RCT™ product candidate is RTX-134 for the potential treatment of phenylketonuria, a rare metabolic disorder.  We expect to report initial clinical data by the end of 2019 from our Phase 1 clinical trial.  Additionally, we plan to file our first oncology Investigational New Drug (IND) application for RTX-240 for the treatment of solid tumors by early 2020.  In total, we plan to file four to five INDs during 2019 and 2020.

We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are based in Cambridge, MA and currently expanding across all functions within the organization.  Having completed our initial public offering in July 2018, (Nasdaq:RUBY), we are well capitalized to execute our vision of creating life-changing cellular medicines. Red blood cells are no longer just for carrying oxygen.  At Rubius, we are transforming them into medicines.  Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn.

Summary
Rubius is seeking a Scientist/Sr Scientist to join the Preclinical Development team with a focus on supporting preclinical safety (toxicology), pharmacokinetic and biodistribution studies for advancing Red Cell Therapeutics. The position reports to Head of Preclinical Development.  This job requires interactions with contract research organizations (CROs) and Rubius’ toxicologists.  We are searching for an enthusiastic and highly motivated individual who is comfortable working in a fast-paced entrepreneurial environment. 

Responsibilities

  • Manage CRO process including assisting in CRO selection, requesting study quotes, leading internal quote approval, monitoring CRO performance according to protocols and GLP compliance, tracking invoices and study phases
  • Assist toxicologists in reviewing non-GLP and GLP study protocols, amendments and reports
  • Collaborate with toxicologists throughout non-GLP and GLP study conduct
  • Travel to CROs to monitor critical phases of the preclinical studies (approximately 10%)
  • Coordinate study-related activities between all internal functions and CROs to meet program needs and timelines
  • Quality check CRO protocols, amendments, reports and regulatory submission documents
  • Identify and implement process improvements within Preclinical Development

Qualifications & Education

  • PhD degree in Toxicology, Biology or related discipline and 4+ years of relevant experience working at a CRO, pharmaceutical or biotechnology industry. Bachelor’s or Masters degree with 8+ years of relevant experience may also be considered
  • Detail-oriented, self-driven individual with a strong work ethic
  • Strong organizational and prioritization skills
  • Experience with GLP regulations for the conduct of preclinical studies
  • Previous experience working with in vivo models
  • Exceptional oral and written communication skills
  • Ability to identify and proactively solve issues in a collaborative manner
  • Previous experience with cellular therapy is a plus
EEO Statement: Rubius Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Recruitment & staffing agencies: Rubius Therapeutics does not accept agency resumes unless contacted directly by internal Rubius Talent Acquisition. Please do not forward resumes to our careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.