Senior Director, Clinical Science
About The Position
Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.
Requirements
- PhD, PharmD, in a relevant scientific or clinical discipline or equivalent experience.
- 12+ years of clinical research/clinical development experience in the biopharmaceutical or pharmaceutical industry, including significant experience in a clinical science leadership role.
- Demonstrated experience authoring clinical protocols, CSRs, and regulatory submission documents.
- Deep knowledge of clinical trial design, GCP, and global regulatory requirements.
- Strong scientific and clinical data interpretation skills, including familiarity with statistical concepts.
- Proficiency with clinical trial management and data visualization tools.
- Proven ability to lead and influence cross-functional teams without direct authority.
- Experience mentoring and developing junior scientific staff.
- Sound judgment in escalating and resolving complex scientific and operational issues.
- Excellent written communication skills, including regulatory and scientific document authoring.
- Strong verbal communication and presentation skills for internal leadership and external regulatory/scientific audiences.
- Ability to translate complex scientific data into clear, actionable insights for varied audiences.
Nice To Haves
- Experience interacting directly with global regulatory agencies (e.g., FDA, EMA) preferred.
- Experience in autoimmune, immunology, or inflammation indications strongly preferred.
Responsibilities
- Serve as the senior clinical/scientific lead on cross-functional study teams, providing scientific direction for protocol design, endpoint selection, and data interpretation.
- Author and critically review clinical study protocols, statistical analysis plans, clinical study reports, and regulatory submission documents (e.g., IND/NDA/BLA sections, briefing documents).
- Partner with Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs to ensure scientifically sound and operationally feasible trial designs.
- Support the design and execution of multiple clinical studies across the development plan
- Study Medical Manager responsibilities from setup through CSR completion, including CRF design, study start-up activities, enrollment monitoring, and patient profile reviews
- Lead the clinical interpretation of emerging safety and efficacy data, including ongoing monitoring of trial data and contribution to Data Safety Monitoring Board materials.
- Represent clinical science in interactions with regulatory authorities, key opinion leaders, and external scientific advisory boards.
- Contribute to the design and execution of clinical development strategy, including lifecycle management and indication expansion planning.
- Lead the development and execution of Clinical Science strategy, priorities, and long-term organizational objectives
- Co-lead establishment of a company-wide clinical trial data management and analytics platform
- Develop future leaders by mentoring Clinical Scientists and associate clinical scientists across program teams, strengthening scientific, strategic, and leadership capabilities across the organization.
- Perform other duties and responsibilities as assigned
Benefits
- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule
- A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
