Clinical Scientist, Clinical Development

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard 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 and IL-17A/F as well as rational combination programs. Role

Summary

As a Director Clinical Scientist at Spyre Therapeutics you will play a key role in designing executing and interpreting clinical trials that support development of our novel antibody-based therapies in rheumatic and/or other I&I diseases. You will collaborate across functions (clinical operations regulatory translational science biomarker teams) to ensure robust study designs high-quality data generation and efficient progression of programs. You will bring scientific and operational expertise and act as a bridge between internal teams external investigators and CRO partners.

Key Responsibilities

Lead/Contribute to study design and amendments in collaboration with internal and external stakeholders. Collaborate with Clinical Development regulatory and other internal partners/stakeholders with authoring and submission of protocols protocol amendments regulatory filings and other regulatory documentation. Collaborate with clinical operations data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs. Work closely with translational science/biomarker teams to integrate mechanistic biomarkers PK/PD modelling patient stratification and exploratory endpoints. Provide scientific oversight and decision-making support during trial execution site selection study start-up monitoring of key trial metrics risk-based quality oversight and study close-out. Interpret clinical data (safety efficacy biomarker PK/PD) and present findings internally (e.g. to senior management or clinical development committee) and externally (investigators scientific meetings publications). Write and/or review abstracts posters content for scientific meetings conferences other events and presentations and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders. Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g. FDA/ICH GCP) and support regulatory submissions and interactions. Develop and maintain clinical trial documentation (protocols clinical study reports investigator brochures informed-consent forms etc.). Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre’s pipeline programs. Additional duties as assigned.

Ideal Candidate

PhD MD PharmD or equivalent in life sciences clinical pharmacology immunology or related discipline is preferred alternatively MSc plus significant industry experience. 5+ years (or more for senior levels) of clinical development experience in the biotech/pharma industry ideally with at least 2 years in rheumatology or other immune-mediated disease area. Demonstrated experience designing and executing clinical trials in rheumatology or other I&I therapeutic area. Strong understanding of clinical biomarkers PK/PD modelling patient stratification and immunologic endpoints. Familiarity with regulatory requirements (FDA/ICH guidelines GCP) and Good Clinical Practice. Proven ability to work cross-functionally in a matrix organization (clinical operations translational science regulatory QA). Excellent written and verbal communication skills presentation and interpersonal skills ability to influence diverse stakeholders. Comfortable working in a fast-paced dynamic environment with ambiguity and willing to wear multiple hats.

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 $215000 to $230000. 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/.