Medical Director, Clinical Development

Beeline Medicines; Boston (MA); Hybrid; USD 266,000 - 340,000; Full time

Benefits offered by this job

Competitive health and wellness coverage

Paid time off

Flexible work arrangements

Job summary

Beeline Medicines is seeking a Medical Director, Clinical Development to lead clinical trials for innovative therapies targeting autoimmune diseases. This role requires a candidate with a strong background in clinical development, particularly in immunology, and involves responsibilities such as trial oversight and regulatory support.

The position is hybrid, requiring at least two days on-site per week in Boston, Massachusetts. A competitive salary range of USD $266,000 – $340,000 is offered, along with various benefits including health coverage and paid time off.

Qualifications

• Minimum of 5 years clinical and biotechnology experience.
• Direct experience treating lupus or systemic sclerosis.
• Proven ability to lead cross-functional teams.

Responsibilities

• Lead medical oversight for clinical trials.
• Contribute to clinical development strategy.
• Support regulatory submissions and interactions.

Skills

Clinical development

Immunology expertise

Regulatory knowledge

Clinical trial management

Education

MD or DO degree

Board certification in rheumatology or immunology

Job description

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.

Job Summary

The Medical Director, Clinical Development – is a therapeutic and disease area specialist who will play a key role in advancing innovative therapies for patients with immunology diseases through high‑quality design and execution of clinical trials. In this role, you will provide medical leadership across a range of clinical development activities, including but not limited to study design, study execution, the monitoring of patient safety, data interpretation, and contribution to regulatory and scientific deliverables. As an internal scientific leader in the field, you will provide input into the overall clinical development strategy for the asset and incorporate insights from key opinion leader interactions into both study design and development strategy. This role involves working closely with internal cross‑functional partners across a range of disciplines to drive high‑quality clinical programs in a fast‑paced biotech environment.

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

• Lead and provide medical oversight for assigned clinical trials including protocol development, study conduct, medical monitoring, data review & interpretation, and clinical study reporting.
• Contribute to clinical development strategy and program plans by integrating scientific rationale, regulatory requirements, safety considerations, operational feasibility, and business objectives.
• Provide medical leadership on trial design, including endpoint selection, eligibility criteria, dose rationale, biomarker strategy, risk‑based monitoring, and interim analysis frameworks.
• Monitor real time data collection throughout study conduct ensuring robust study conduct and protocol adherence.
• Support pharmacovigilance activities during trial conduct — monitor patient safety and benefit‑risk throughout study conduct through review of adverse events, serious adverse events, laboratory data, safety narratives, and aggregate safety information, and contribute to related safety governance activities in coordination with the Global PV Medical Director.
• Serve as a key medical resource for investigative sites, external advisors, and clinical investigators, ensuring patients meet the appropriate eligibility criteria, responding to clinical and safety inquiries and supporting external interactions, advisory boards, and scientific communications as appropriate.
• Lead and conduct peer‑to‑peer scientific exchange with KMEs, investigators, and HCPs — sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights that inform overall development strategy.
• Review, author, and contribute to key clinical and regulatory documents, including protocols, protocol amendments, investigator brochures, informed consent forms, clinical study reports, briefing materials, and health authority responses.
• Support regulatory interactions and submissions by providing medical and scientific input for agency meetings, annual reports, and clinical sections of regulatory filings.
• Serve as the clinical development lead for an asset if required.
• Perform other duties and responsibilities as assigned.

Qualifications

• Education: Advanced clinical degree (MD or DO) or MD/PhD required. Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty strongly preferred. Additional advanced degree (PhD, MPH, or MBA) is a plus.
• Minimum of 5 years of combined clinical and pharmaceutical/biotech industry experience.
• Direct experience treating, or managing lupus (SLE and/or CLE) and/or systemic sclerosis patients/clinical programs strongly preferred.
• Deep scientific expertise in autoimmune disease — rheumatology, specifically lupus (SLE and/or CLE) or systemic sclerosis, preferred.
• Direct experience of phase 1–3 clinical studies in particular; authoring clinical trial protocols, clinical development plans and regulatory submission documents.
• Deep clinical and scientific expertise in immunology and inflammation — including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches.
• Proven ability to identify, characterize, and mitigate clinical, operational, and regulatory risks across multi‑site, multinational clinical programs.
• Demonstrated ability to lead and influence cross‑functional teams in a matrixed, fast‑paced biotech or pharmaceutical environment without direct line authority.
• Proven ability to build alignment across diverse internal and external stakeholders, including senior leadership, clinical operations, regulatory, and commercial partners.
• Track record of driving program‑level decisions with clarity and accountability, balancing scientific rigor with business urgency in resource‑constrained settings.
• Exceptional scientific communication skills, with the ability to articulate complex medical and clinical data to senior leadership, health authorities, clinical investigators, and external partners.
• Demonstrated scientific writing proficiency, including the ability to evaluate and present complex data sets in regulatory documents, clinical study reports, and scientific publications.
• Skilled at facilitating high‑stakes discussions — including advisory boards, cross‑functional program reviews, and health authority interactions — with confidence and precision.

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.

USD $266,000 – $340,000

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

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 [e-mail] 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 the Privacy Policy – Beeline Medicines.