Spyre Therapeutics - Senior Medical Director, Clinical Development

Remote - US- Remote$343k - $365k+ Equity1mo ago

Remote Director NA Pharmaceuticals Biotechnology Clinical Director Documentation Reporting Clinical Trials GCP Cross-functional Collaboration Regulatory Affairs Later

Requirements

• MD or equivalent medical degree is required. • Minimum of 4+ years clinical development experience within the pharmaceutical or biotech industry within I&I indications, rheumatology strongly preferred. • 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.

Responsibilities

• Clinical Leadership: Contribute strategic leadership and medical expertise to the clinical development of our cutting-edge antibody portfolio in rheumatic indications. • Trial Management: Contribute to 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 Clinical Operations to support 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: Represent the Clinical Development function in interactions with regulatory agencies, investigators, KOLs, and other external stakeholders, as appropriate. • Other activities as required.

Benefits

• 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. • 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 $343,000 to $365,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.