About Beeline Medicines:
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.
Job Summary:
The Senior Director, Clinical Science provides senior scientific and strategic leadership for the design, execution, and interpretation of clinical trials across one or more therapeutic programs. Acting as a key scientific expert and thought partner to program and functional leadership, this individual shapes clinical development strategy from early-phase proof-of-concept through late-stage registration and lifecycle management. The role requires close, ongoing collaboration with Biostatistics, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and external investigators and key opinion leaders to ensure that trial designs are scientifically sound, operationally feasible, and aligned with evolving regulatory expectations. The Senior Director is expected to exercise independent scientific judgment on complex, ambiguous problems, represent the organization credibly in front of regulatory authorities and scientific advisory boards, and mentor and develop junior clinical scientists, building both the technical depth and strategic thinking of the broader clinical science function.
Work Arrangement & Location:
Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.
Essential Duties and 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
Qualifications:
- Education: 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.
- Experience interacting directly with global regulatory agencies (e.g., FDA, EMA) preferred.
- Experience in autoimmune, immunology, or inflammation indications strongly preferred.
- 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.
Salary Range:
The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.
Benefits:
We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:
- 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
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.
Equal Employment Opportunity:
Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Reasonable Accommodation:
If you require a reasonable accommodation to participate in the application or interview process, please contact [email protected] to request an accommodation. We are committed to providing equal access to all candidates.
Privacy
Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines
Skills Required
- PhD, PharmD, or equivalent experience in a relevant scientific or clinical discipline
- 12+ years clinical research/clinical development experience in biopharmaceutical or pharmaceutical industry
- Demonstrated experience authoring clinical protocols, clinical study reports (CSRs), and regulatory submission documents
- Deep knowledge of clinical trial design, Good Clinical Practice (GCP), and global regulatory requirements
- Strong scientific and clinical data interpretation skills with familiarity of 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 clinical scientists
- Excellent written and verbal communication skills for regulatory and scientific audiences
- Experience interacting directly with global regulatory agencies (e.g., FDA, EMA)
- Experience in autoimmune, immunology, or inflammation indications
What We Do
Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies for people living with autoimmune and inflammatory diseases. The company leverages a mechanistically-guided approach to target the underlying drivers of immune dysfunction, aiming to define new treatment paradigms and provide durable, life-changing impact for patients suffering from a broad array of devastating immune-mediated conditions to improve patient outcomes.
