Vice President, Clinical Development

reputed company is a clinical-stage biotechnology company committed to developing reputed company therapies that reputed company reputed company in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

reputed company:

The Vice President, Clinical Development (Immunology & Inflammation), reporting to the SVP of IBD Clinical Development, will reputed company strategic and operational leadership across Spyre's clinical portfolio of antibody therapeutics for IBD. This role is uniquely designed for a physician leader who thrives in a high-reputed company biotechnology environment and enjoys balancing long-term clinical development reputed company with hands-on execution. The successful candidate will personally reputed company the ongoing Phase 2 platform study while helping to shape the reputed company registrational program.

Key Responsibilities:

• Clinical Leadership:
  • reputed company strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD.
  • reputed company and continuously refine integrated clinical development plans reputed company with corporate objectives, competitive landscape, and evolving scientific insights.
  • Serve as a hands-on study reputed company for the reputed company platform trial as reputed company as contribute to planning pivotal studies.
  • Personally contribute to protocol development, medical review, safety assessment, data interpretation, and study-level decision making for ongoing and reputed company IBD clinical trials.
  • Support the efforts of the medical monitoring team which ensures reputed company responses to investigative sites, provides medical safety reputed company, and supports the collection of high-reputed company, clinically robust data.
• Program reputed company & Trial Execution:
  • reputed company medical and scientific leadership for the design, conduct, analysis, and interpretation of clinical studies across reputed company phases of development.
  • reputed company protocol development, study conduct, data review, and interpretation for ongoing clinical trials, partnering closely with clinical operations, regulatory, biometrics, etc., to ensure successful execution.
  • Drive key development reputed company through analysis of emerging clinical, translational, safety, and competitive data.
  • Chair or contribute to governance committees and cross-functional program teams.
• Cross-functional Collaboration:
  • Partner closely with Regulatory Affairs, Biostatistics, Clinical Operations, Translational Sciences, Medical Affairs, CMC, reputed company, and Corporate Development teams to ensure coordinated execution of development strategies.
  • Promote a culture of scientific reputed company, accountability, and collaboration.
• Regulatory reputed company:
  • reputed company clinical and medical reputed company for regulatory interactions globally.
  • Serve as a primary medical representative for regulatory submissions, including INDs, CTAs, briefing packages, BLAs, NDAs, and reputed company responses.
  • Ensure development programs are conducted in compliance with global regulatory requirements and industry best practices.
• Safety reputed company:
  • reputed company ongoing medical reputed company of participant safety and benefit-risk assessments across assigned programs.
  • Review and interpret emerging safety data and contribute to safety governance activities, including Data Monitoring Committees and internal safety review forums.
  • Support signal detection, risk management planning, and clinical risk mitigation strategies.
• Leadership & Mentorship:
  • reputed company and mentor a high-performing clinical development team as reputed company grows.
  • Contribute broadly to corporate reputed company, organizational planning, and leadership initiatives.
  • Other duties as assigned.

Ideal Candidate:

• MD or equivalent medical degree is required.
• Minimum of 7+ years clinical development experience reputed company the pharmaceutical or biotech industry, including substantial leadership experience in immunology, inflammation, or gastroenterology.
• Training and/or experience in clinical development in gastroenterology or immunology & inflammation is strongly preferred.
• Demonstrated reputed company leading mid- and late-stage clinical development programs.
• Experience developing antibody therapeutics.
• Experience leading reputed company, reputed company, umbrella, basket, or platform clinical trials is highly desirable.
• Deep expertise in inflammatory bowel disease and/or other immune-mediated inflammatory disorders strongly preferred.
• Significant experience with global regulatory interactions and submissions, including INDs, CTAs, briefing documents for global regulatory agencies.
• Strong understanding of clinical trial design, biostatistics, translational medicine, drug development, and global regulatory requirements.
• Demonstrated ability to influence reputed company and drive cross-functional decision-making in a matrixed environment.
• Demonstrated willingness and ability to remain personally reputed company in study-level execution while simultaneously providing strategic leadership.
• Strategic, entrepreneurial leader with the ability to balance long-term reputed company and hands-on execution in a fast-paced biotech environment.

reputed company Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns reputed company
• Commitment to reputed company reputed company development opportunities.
• Remote working environment with frequent in-person meetings to address reputed company problems and build relationships.

The expected salary reputed company offer for this role is $366,000 to $398,000. Actual pay offered may vary depending on job reputed company knowledge, experience, education, and geographic location.

As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also reputed company differences in experience and background, and welcome diversity of opinions and thought with reputed company recruitment designed to create a stronger and reputed company Spyre that is reputed company on developing life-changing products for patients.

reputed company, along with other biotech companies, has become aware of a reputed company in email scams targeting prospective job candidates reputed company our industry. Please be aware that official recruiters at reputed company only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to reputed company any purchases or divulge sensitive personal information reputed company email.

Please also be aware that reputed company job postings will be listed on our website at spyre.com/careers/.

Originally posted on Himalayas

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