Senior Medical Director, Clinical Development

BioSpace; Boston (MA); Hybrid; USD 293,000 - 380,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Hybrid schedule

Job summary

Beeline Medicines is seeking a Senior Medical Director, Clinical Development to provide strategic medical leadership across inflammation & immunology programs. You will own clinical strategy, mentor junior physicians, and contribute to portfolio decisions in a fast-paced biopharmaceutical environment.

The role requires an MD/DO with 10+ years in clinical and biotech settings, including Phase I–III experience and strong regulatory and scientific acumen.

Qualifications

• Advanced clinical degree required; board certification in rheumatology/nephrology/immunology strongly preferred.
• Minimum 10 years combined clinical and biotech/pharma experience; 5+ years in clinical development with increasing responsibility.
• Deep scientific expertise in autoimmune disease and immunology/inflammation; experience leading Phase I–III programs.

Responsibilities

• Act as physician medical lead for multiple clinical programs from I through III.
• Design and review protocols, IBs, informed consent, and regulatory submission documents.
• Provide medical oversight of ongoing trials: safety monitoring and risk assessment.
• Lead regulatory interactions with FDA/EMA and respond to health authority questions.
• Coordinate cross-functional teams across Clinical Operations, Regulatory Affairs and Biostatistics.
• Engage with KOLs and academic centers to strengthen clinical network.

Skills

Clinical leadership

Regulatory submissions

Trial oversight

Medical communications

Cross-functional collaboration

KOL relationships

Education

MD/DO required

Board certification in rheumatology/nephrology/immunology

Advanced degree (PhD/MPH/MBA)

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. 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.

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 Medical Director, Clinical Development is a senior physician-scientist who provides strategic medical leadership for one or more clinical programs within the organization’s Inflammation & Immunology pipeline. Building on deep therapeutic area expertise and a proven track record in clinical trial execution, this role bridges hands‑on clinical program leadership with broader cross‑functional and organizational accountability. The Senior Medical Director serves as the primary physician lead for assigned assets, owning the clinical strategy and development plan across multiple phases, while also playing an increasingly prominent role in shaping departmental capabilities, mentoring junior physicians, and contributing to portfolio‑level decision‑making. This role requires the ability to work with independence and authority in a fast‑paced, growth‑stage biopharmaceutical 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

• Serve as the physician medical lead for assigned clinical development programs — owning the clinical development strategy, integrated development plan, and medical decision‑making for pipeline assets across Phase I through Phase III development, with increasing accountability for program‑level outcomes and portfolio contributions.
• Lead the design, authorship, and review of clinical trial protocols, investigator brochures, informed consent documents, and clinical sections of regulatory submissions (IND, NDA/BLA, global filings) — ensuring scientific rigor, patient safety, and regulatory compliance across all deliverables.
• Provide comprehensive medical oversight of ongoing clinical trials — including safety monitoring, medical monitoring, SAE assessment, protocol deviation review, and benefit‑risk evaluation — in close partnership with Clinical Operations, Pharmacovigilance, and Biostatistics.
• Lead and actively represent the organization in regulatory agency interactions — including FDA and EMA meetings, briefing document development, and responses to health authority questions — serving as a primary medical spokesperson for assigned programs and contributing to regulatory strategy.
• Support pharmacovigilance activities during trial conduct — Drive cross‑functional clinical program teams as the senior medical lead — providing strategic scientific direction to Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and Medical Affairs — and ensure integrated, high‑quality program execution with clear accountability and pace.
• Build and maintain relationships with key opinion leaders (KOLs), principal investigators, and academic medical centers to strengthen the organization’s clinical network, gather external scientific insights, and support the medical positioning of pipeline assets.
• Perform other duties and responsibilities as assigned

Qualifications

• Education: Advanced clinical degree (MD or DO) 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 10 years of combined clinical and pharmaceutical/biotech industry experience, with a minimum of 5 years in a clinical development role with increasing levels of responsibility preferred
• Deep scientific expertise in autoimmune disease — rheumatology preferred.
• Demonstrated experience as a physician lead on Phase I–III clinical programs, including hands‑on protocol development, medical monitoring, and regulatory submission experience
• 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 serve as the senior medical authority on cross‑functional program teams — setting scientific direction, resolving complex medical questions, and building alignment across diverse functional stakeholders
• Strong track record of leading clinical programs through critical milestones — including first‑in‑human studies, proof‑of‑concept readouts, pivotal trial initiation, and regulatory submissions — with a bias for rigor, speed, and quality
• Effective at delivering data‑driven recommendations to senior leadership, adapting communication to drive informed decision‑making at the organizational and portfolio level
• Collaborative and influential leader who builds trust and credibility with clinical investigators, KOLs, and regulatory agencies — leveraging scientific expertise and interpersonal effectiveness to advance the organization’s programs and reputation
• Exceptional scientific and medical communication skills — able to present complex clinical data, safety findings, and development strategies clearly and compellingly to diverse audiences including regulators, investigators, executives, and patient communities
• Skilled in authoring and reviewing high‑quality clinical documents including protocols, investigator brochures, clinical study reports, regulatory briefing documents, and scientific manuscripts

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.

Salary Range

$293,000 - $379,500 USD

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 [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 Privacy Policy - Beeline Medicines