Qureos Mentor

Spyre Therapeutics

<div><div><p>Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (&ldquo;IBD&rdquo;) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting &alpha;4&beta;7, TL1A, and IL-23.</p></div><div><p><b>
Role Summary:</b></p>
<p>
The Associate Director, Drug Product is a key leadership role responsible for overseeing technical operations related to drug product (DP) formulation, development, and manufacturing. This position requires close collaboration with cross-functional teams, including CMC, supply chain, clinical operations, regulatory, quality, and senior management.</p>
<p>
This role will lead the development of protein drug product processes and associated technical presentations, oversee technology transfer to CDMOs, and ensure the reliable delivery of high-quality DP supplies to support clinical trials. The ideal candidate brings deep expertise in process development, aseptic manufacturing (including prefilled syringes), combination product development, and GMP compliance.</p>
<p>
As a subject matter expert (SME) in DP manufacturing within the CMC organization, this individual will provide strategic direction and technical leadership across internal teams and external partners, driving alignment and execution from development through clinical supply.</p>
<p><b>
Key Responsibilities:</b></p>
<ul>
<li>Serve as a SME in DP process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams</li>
<li>Develop late-phase and commercial launch strategy for PFS and vial drug products</li>
<li>Oversee DP tech transfer, process development, and GMP manufacturing operations including person in plant (PiP) support</li>
<li>Manage DP CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members</li>
<li>Support phase-appropriate strategies for DP development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness</li>
<li>Perform risk assessments using a QbD approach to define DP process validation strategies</li>
<li>Collaborate with manufacturing development and device teams to develop DP presentations in vial, PFS, autoinjector, and advanced drug delivery technologies</li>
<li>Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations</li>
<li>Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)</li>
<li>Other duties as assigned</li>
</ul>
<p><b>Ideal Candidate:</b></p>
<ul>
<li>Bachelor&rsquo;s degree or advanced degree in chemical engineering, biochemical engineering, chemistry, biotechnology or related field, or commensurate years of education and experience</li>
<li>Minimum 8[JS2.1] years of relevant experience in biotech/pharma industry</li>
<li>Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies</li>
<li>Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations</li>
<li>Experience with process performance qualification (PPQ) and commercialization of biologics</li>
<li>Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory</li>
<li>Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams</li>
<li>Availability to participate in calls across international time zones</li>
<li>Position requires up to 25% of domestic travel. In person attendance at Spyre All Hands meetings is required, typically held twice per year.</li><br>
</ul>
<p><b>What We Offer:</b></p>
<ul>
<li>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.</li>
<li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits.</li>
<li>Unlimited PTO</li>
<li>Two, one-week company-wide shutdowns each</li>
<li>Commitment to provide professional development opportunities.</li>
<li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li>
</ul>
<p>The expected salary range offer for this role is $180,000 to $193,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.</p></div><div><p>
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.</p>
<p>
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 &ldquo;@spyre.com.&rdquo; We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.</p>
<p>
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</p></div></div>

Associate Director, Drug Product

<div><div><p>Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (&quot;IBD&quot;) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting &alpha;4&beta;7, TL1A, and IL-23.</p></div><h3 class="jobSectionHeader"><b>
Role Summary:</b></h3>
<p>
Spyre Therapeutics is seeking a highly strategic and hands-on commercial leader to shape the future commercial success of our lead assets across IBD and rheumatology as we advance from Phase 2 into Phase 3 and ultimately launch. This individual will serve as a key commercial leader in the company, integrating market access, commercial strategy, and early marketing insights to ensure the portfolio is positioned for optimal value, adoption, and access at launch.</p>
<p>
This role requires a builder and strategic mindset, comfort with ambiguity, and the ability to influence cross-functional decisions that will define the product's long-term commercial trajectory.</p>
<h3 class="jobSectionHeader"><b>
Key Responsibilities:</b></h3>
<h4 class="jobSectionHeader"><b>Market Access &amp; Value Strategy</b></h4>
<ul><li>Develop the global pricing strategy, including scenario planning, pricing corridors and gross-to-net assumptions</li>
<li>Map evidence requirements and gaps to support global payer and HTA decision-making</li>
<li>Build early payer engagement strategy and plan</li>
<li>Assess patient support landscape and build launch strategy, inclusive of hub, call center, copay, nurse, and field reimbursement</li>
<li>Develop US channel strategy for Spyre launch brands</li>
<li>Determine optimal global launch waves and sequencing to optimize commercial value</li>
<li>Regularly monitor global policy and pricing landscape changes and assess impact to Spyre portfolio</li>
<li>Partner with competitive intelligence team to monitor competitor pricing and access dynamics and impact to Spyre</li>
</ul><h4 class="jobSectionHeader"><b>Commercial &amp; Asset Strategy</b></h4>
<ul><li>Partner with CCO and corporate strategy team to refine commercial strategy as Spyre clinical profiles solidify and the competitor landscape shifts</li>
<li>Influence Phase 3 clinical trial design to ensure alignment with key commercial considerations including pricing, access and demand</li>
<li>Partner with R&amp;D, Regulatory and Corporate Strategy to refresh target product profile (TPPs)</li>
<li>Identify and mitigate key commercial risks ahead of Phase 3 investment decisions</li>
<li>Conduct market research to assess drivers of physician adoption and patient access</li>
</ul><h4 class="jobSectionHeader"><b>Launch Planning</b></h4>
<ul><li>Partner with CCO to build an integrated launch plan, including a detailed commercial launch plan inclusive of commercial resourcing and organizational design</li>
<li>Identify and partner with external partners who can support commercial launch preparation</li>
</ul><h4 class="jobSectionHeader"><b>Forecasting &amp; Analytics</b></h4>
<ul><li>Lead commercial forecasting and scenario modeling, incorporating market access dynamics, competitive landscape, and adoption assumptions</li>
<li>Partner with Finance team to conduct ROI assessments to aid with portfolio prioritization and launch sequencing strategy</li>
</ul><h4 class="jobSectionHeader"><b>External Engagement</b></h4>
<ul><li>Generate insights through engagement with payers, KOLs, and advisors</li>
<li>Partner with Medical team to execute cross-functional KOL engagement plan</li>
</ul><h4 class="jobSectionHeader"><b>Cross-Functional Leadership</b></h4>
<ul><li>Serve as the commercial lead on Spyre Product Teams</li>
<li>Ensure alignment between development strategy and commercial success factors</li>
<li>Contribute to Board and investor materials</li>
<li>Engage with potential strategics and represent commercial voice in discussions</li>
</ul><h4 class="jobSectionHeader"><b>Team Leadership</b></h4>
<ul><li>Identify and recruit top talent to join commercial organization as the team grows</li>
<li>Lead, develop and mentor future direct reports</li>
<li>Other duties as assigned</li>
</ul><h3 class="jobSectionHeader"><b>Ideal Candidate:</b></h3>
<ul><li>12+ years of experience in biotech/pharma across market access, commercial strategy, and/or marketing</li>
<li>Demonstrated experience developing biotech/pharma commercial and access strategy for assets in Phase 2 and Phase 3 development</li>
<li>Commercial launch and/or in-line experience, in market access and/or marketing</li>
<li>Expertise partnering with R&amp;D, Medical and Regulatory to develop value maximizing Phase 3 designs and TPPs</li>
<li>Deep understanding of global payer dynamics, pricing strategy, and patient access/services</li>
<li>Experience in commercial forecasting and strategic planning</li>
<li>Experience building commercial and cross-functionally integrated launch plans</li>
<li>Track record of successfully influencing across functions</li>
<li>Excellent communication skills with the proven ability to work effectively in a fast-paced environment</li>
</ul><h3 class="jobSectionHeader"><b>What We Offer:</b></h3>
<ul><li>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.</li>
<li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits.</li>
<li>Unlimited PTO</li>
<li>Two, one-week company-wide shutdowns each</li>
<li>Commitment to provide professional development opportunities.</li>
<li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li>
</ul>
<p>The expected salary range offer for this role is $330,000 to $357,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.</p><div><p>
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.</p>
<p>
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 &quot;@spyre.com.&quot; We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.</p>
<p>
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</p></div></div>

Vice President, Commercial Strategy & Market Access

<div><div><p>Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (&quot;IBD&quot;) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting &alpha;4&beta;7, TL1A, and IL-23.</p></div><p><b>
Role Summary:</b></p>
<p>
As the Associate Director, Regulatory Affairs (CMC and Devices), you will play a key role in executing CMC and potentially Device regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC and Device regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC and Device-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities.</p>
<p>
You will lead submissions across multiple drug candidates and work closely with Regulatory colleagues, Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents.</p>
<p><b>
Key Responsibilities:</b></p>
<ul>
<li>Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs.</li>
<li>Technical Authoring: Independently author and compile Module 2 and Module 3 content, including quality overall summaries, drug substance, drug product and regional sections, stability summaries, comparability assessments, and supporting technical reports.</li>
<li>Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone.</li>
<li>Device &amp; Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions.</li>
<li>Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression.</li>
<li>Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions.</li>
<li>Other duties as assigned.</li>
</ul>
<p><b>Ideal Candidate:</b></p>
<ul>
<li>Bachelor's degree with a minimum of 6+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience).</li>
<li>Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation.</li>
<li>Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development.</li>
<li>Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations.</li>
<li>Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus.</li>
<li>Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.</li>
<li>Meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment.</li>
<li>Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams.</li>
<li>Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).</li>
</ul>
<p><b>What We Offer:</b></p>
<ul>
<li>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.</li>
<li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits.</li>
<li>Unlimited PTO</li>
<li>Two, one-week company-wide shutdowns each</li>
<li>Commitment to provide professional development opportunities.</li>
<li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li>
</ul>
<p>The expected salary range offer for this role is $175,000 to $195,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.</p><div><p>
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.</p>
<p>
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 &quot;@spyre.com.&quot; We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.</p>
<p>
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</p></div></div>

Associate Director, Regulatory Affairs CMC and Devices

Join Spyre Therapeutics and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Spyre Therapeutics

About Company

Associate Director, Drug Product

Vice President, Commercial Strategy & Market Access

Associate Director, Regulatory Affairs CMC and Devices