Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation of inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Role Summary
The Senior Director of Clinical Development for Immunology and Inflammation will lead the clinical development strategy and execution for innovative therapies targeting immunological and inflammatory indications. The Senior Director will play a pivotal role as a clinical lead within our global clinical development programs, reporting into the SVP, Clinical Development. This role will design, plan, and implement study protocols, collaborate with cross-functional teams and support regulatory activities to advance the development of our cutting-edge antibody portfolio. This individual will join the Clinical Development tram at a relatively early stage and will play a key role in directing research and formulating strategy to drive program success.
Key Responsibilities
- Clinical Leadership: Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in I&I indications.
- Trial Management: Oversee the study design, execution and interpretation of results, with a focus on proof-of-concept and later phases of development.
- Cross-functional Collaboration: Work closely with cross-functional teams including Biostatistics, Regulatory Affairs, and Development Operations to ensure integrated and strategic trial execution.
- Regulatory: Provide scientific/medical content and other input as appropriate for INDs, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Ensure compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters.
- Safety Oversight: Ensure the safety of study participants by actively participating in safety monitoring and data review processes.
- Stakeholder Engagement: Serve as the primary medical representative, interfacing with regulatory agencies, investigators, and KOLs.
- Other activities as required.
Ideal Candidate - Education: MD or equivalent medical degree is required.
- Experience & Skills:
- Minimum of 3-5+ years clinical development experience within the pharmaceutical or biotech industry within I&I indications.
- Experience with antibody therapeutics preferred.
- Proven track record in designing and executing clinical trials in immunology or inflammation.
- Experience with regulatory filings and interactions with health authorities.
- Strong understanding of GCP, clinical trial design, statistics, and global regulatory processes.
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.
- Ability to manage complex projects in a fast-paced environment.
What We 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 base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $325,000 to $345,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
