Goldfinch Bio

Job Title: Vice President, Regulatory Affairs and Quality

Job Number: 23169

Location: 215 First Street 4th Floor Cambridge, MA 02142

Job Description

Goldfinch Bio seeks a talented, highly motivated and highly qualified individual for the position of Vice President of Regulatory Affairs and Quality (VP-RA).  This position is based in Cambridge, MA and reports to the Chief Medical Officer (CMO). The VP-RA will provide strategic and operational leadership in the management of all regulatory aspects of clinical development, medical affairs, and regulated commercial activities for all of Goldfinch Bio’s products (both small molecule and biologics) in its stated area of therapeutic interest: rare and chronic kidney disease targeted by genomic discovery, and optimized using biomarkers into precision medicines. This position will also oversee and manage all aspects of Quality and regulatory compliance for the company. Goldfinch Bio believes genetic insights are critical to discovering and developing drugs which will safely provide clinically relevant benefits desired by patients The VP-RA fulfills a critical and highly visible role as a key strategist and team member in Goldfinch Bio’s target discovery and clinical development teams, making substantial contributions to the company.
 

Responsibilities

  • Responsible for the strategic regulatory considerations in creation and implementation of product development plans (PDP) across multiple kidney diseases and indications toward the development of druggable targets and biomarkers for precision therapies
  • Keeps current with relevant regulatory, scientific and medical literature and guidelines in support of innovative, efficient and productive clinical-regulatory strategies for optimizing development and productivity of Goldfinch Bio’s product pipeline
  • Plans, coordinates and executes on identification of, and contracting with US and international regulatory consultants and vendors to support development, compilation and delivery of high-quality submissions across the full range of drug development to regulatory agencies and bodies (e.g., INDs, protocols, NDA/BLA eCTDs, REMS, PSURs, value dossiers)
  • Assists in collaboratively optimizing trial designs via the adoption or creation of meaningful endpoints and scientifically and regulatorily acceptable analyses and presentations of data (both in writing (e.g., briefing packages) and at meetings (FDA Type A, B, C, CRDAC, CHMP, EMA, PMDA) with regulatory bodies). In collaboration with our Clinical Development department, ensure these trials are appropriate to the Goldfinch Bio’s and consumers’ (patient, prescriber, regulator, payor) objectives
  • Builds strong regulator relationships
  • Reviews and provides Goldfinch Bio’s regulatory feedback for draft regulatory guidance and other relevant “request for comment” solicitations from governmental agencies or industry consortia
  • Serves as Goldfinch Bio’s regulatory representative to governmental and regulatory agencies as well as to industry meetings
  • Drives development of, and adherence to, standard operating procedures and working practices in compliance with good laboratory, clinical, and manufacturing practices (GXP)
  • Supports appropriate and timely reporting of deviations from GXP and of critical pharmacovigilance findings and their corrective and preventative actions (e.g., IB or labeling updates and communications to prescribers)

 

Required Skills

  • Advanced clinically, biomedical research-oriented degree and training (life-sciences PhD, PharmD or equivalent at a minimum; research-experienced MD or MD/PhD ideal)
  • At least 10 years of experience in a comparable regulatory affairs role at a pharmaceutical or biologics-oriented Sponsor company or organization
  • Matrix or direct personnel and project management experience preferred
  • Ability to thrive in a fast-paced, innovative work environment while remaining flexible, proactive, resourceful and efficient
  • A working knowledge of regulatory submissions tools and processes, with ability to manage/support varied regulatory submissions
  • Experience in Kidney, Metabolic and/or Rare Disease therapeutic areas and interest is strongly preferred
  • Excellent verbal, written and presentation communication skills are essential
  • Skilled in the latest principles and applications of regulatory science for drug development
  • An innate understanding biopharmaceutical business strategy: i.e. the interdependence of scientific discovery and entrepreneurial business development
  • Deep knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials toward regulatory approval
  • Knowledge of applicable HHS and FDA standards for adequate provisions to protect the privacy of subjects and to maintain confidentiality of data
  • Ability to travel up to 15%

 

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