Spyre Therapeutics

👥 1-50💰 $180,000,000 Post-IPO Equity over 1 year agoBiotechnologyTherapeutics📈 Public Company
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Spyre Therapeutics is a biotechnology company focused on developing innovative antibody therapies aimed at transforming the treatment landscape for inflammatory bowel disease (IBD).

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📍 US

💸 255000.0 - 295000.0 USD per year

🔍 Biotechnology

  • Ph.D. in Pharmacology, Pharmaceutical Sciences, or related field, with a strong focus on clinical pharmacology.
  • A minimum of 10 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry, with significant experience in antibody development.
  • Proven track record of accomplishment in drug development, from early-stage research through to regulatory submission and approval.
  • Extensive experience with regulatory submissions and interactions with health authorities, particularly the FDA and EMA.
  • Strong analytical and problem-solving skills, with expertise in PK/PD modeling and simulation.
  • Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.
  • Lead the strategic planning and execution of clinical pharmacology studies, including PK/PD modeling, dose-response analysis, and bioequivalence studies.
  • Collaborate closely with cross-functional teams, including clinical development, non-clinical development, DMPK, regulatory affairs, and clinical operations, to ensure alignment and integration of clinical pharmacology principles throughout the drug development process.
  • Oversee the development and implementation of modeling and simulation strategies to predict drug behavior, optimize dosing, and support clinical trial design.
  • Provide expert guidance on clinical pharmacology topics to regulatory submissions and interactions with health authorities worldwide.
  • Stay abreast of emerging trends and regulations in clinical pharmacology and antibody development to ensure Spyre Therapeutics remains at the cutting edge.

Data AnalysisCross-functional Team Leadership

Posted 11 days ago
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📍 US

🧭 Full-Time

💸 100000.0 - 112000.0 USD per year

🔍 Biotechnology

  • Bachelor’s degree in accounting; Master’s degree preferred
  • CPA preferred
  • 3 - 5 years of accounting experience
  • Public audit and industry accounting experience; combination of small and large company experience preferred
  • Strong general ledger accounting and internal controls background
  • Knowledge of monthly closings and US GAAP
  • Experience understanding and maintaining internal controls, policies and procedures
  • Knowledge of financial systems (including major ERPs and purchase-to-pay systems)
  • High level of proficiency in Excel (v-lookup, pivots, etc.), Word, and PowerPoint are required
  • Excellent organizational, analytical, prioritization and problem-solving skills in an environment of high volume of projects; detail-oriented
  • Possesses a professional demeanor, discretion and judgment
  • Ability to work effectively and establish and promote positive relationships
  • Self-starter who possesses initiative and ability to work alone while capable of driving business results without significant supervision
  • Must have schedule flexibility to meet the demands of monthly and quarterly close
  • Excellent verbal and written communication skills
  • Ability to work effectively with persons at all levels
  • Perform full-cycle general ledger accounting, including preparing schedules and journal entries, and performing various account reconciliations
  • Ensure reporting calendar is met by working cohesively with the accounting/finance team
  • Manage multiple tasks under tight deadlines with strong attention to detail and accuracy
  • Collaborate with other departments and third parties to facilitate the timely and accurate receipt of financial data
  • Provide detailed support and timely communications to assist with the external audit process
  • Assist with quarterly analysis of financial statements
  • Assist with maintaining the company’s ERP and other accounting systems
  • Formulate and recommend system and process changes through evaluation, analysis of controls, and application of GAAP
  • Maintain ownership and documentation of business processes and key controls for Sarbanes- Oxley compliance
  • Understand and enforce accounting policies and procedures
  • Ad-hoc reporting and analysis
  • Other duties as assigned

AccountingBudgetingFinancial analysisBookkeeping

Posted 17 days ago
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🔥 Senior Medical Writer
Posted 28 days ago

💸 140000.0 - 157000.0 USD per year

🔍 Biotech/pharmaceutical

  • 4+ years of regulatory medical writing experience within the biotech/pharmaceutical industry
  • Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
  • Excellent leadership, collaboration, communication, and interpersonal skills
  • Strong problem-solving and critical thinking abilities
  • Ability to meet deadlines and adapt to changing priorities
  • Proficiency in word processing software and document management systems
  • Author clinical study protocols, amendments, IBs, and other supporting documents
  • Author CSRs and data summaries for INDs, CTAs, BLAs, and MAAs
  • Identify risks and contribute to risk mitigation or contingency planning for submission activities
  • Contribute to the maintenance of document templates, job aids, and training materials. Identify opportunities for process improvement.
  • Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.
  • Other duties as assigned.
Posted 28 days ago
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