Clinical Development Physician

Syst Immune is a leading and well‑funded clinical‑stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi‑specific, multi‑specific antibodies, and antibody‑drug conjugates (ADCs). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, along with a robust preclinical pipeline of potential cancer therapeutics in the discover and IND‑enabling stages.

The Clinical Development Physician will be a key integral member of the clinical development team, serving as a medical director/monitor for one or more oncology trials. Reporting to the Executive Director, Clinical Development, the physician will provide clinical oversight, medical monitoring, and execution of one or two key assets in Phase 1–3 clinical trials in solid tumor or hematology indications. The role will act as the primary clinical development contact between sites/ principal investigators, CROs, and the company, ensuring study conduct aligns with the clinical development protocol, regulatory requirements, and safety standards.

The position offers opportunities for protocol development, strategic discussion, and cross‑alliance engagement, and is at an associate director or director level with high leadership visibility.

1. Clinical Study Leadership & Design

• Support the Executive Director in the design and refinement of clinical protocols, amendments, and informed consent documents.
• Lead the development of key clinical documents, including Investigator Brochures (IB), Study Manuals, and Clinical Study Reports (CSR).
• Ensure study‑level execution aligns with the Clinical Study Protocols.

2. Medical Monitoring & Safety Oversight

• Serve as the primary Medical Monitor (or coordinate with external monitors) to perform real‑time data reviews, assess patient eligibility, and manage safety queries.
• Lead the clinical review of safety data (SAEs, AEs, and laboratory trends) to identify potential signals and ensure patient safety across sites with the Safety Lead.
• Collaborate with Pharmacovigilance and Data Management to ensure the “cleanliness” and integrity of clinical databases for interim and final analyses.

3. Cross‑Functional Coordination & Alliance Support

• Support cross‑functional discussion with Clinical Operations, Biostats, Regulatory, and Medical Writing.
• Support alliance management activities by preparing technical updates and data summaries for partners.
• Provide clinical expertise to CROs and external vendors to ensure high‑quality deliverables and adherence to timelines.

4. Regulatory & Scientific Communication

• Assist in the preparation of Health Authority briefing packages (FDA/EMA) and participate in regulatory interactions as the study‑level expert.
• Support the development of abstracts, posters, and manuscripts for major congresses (ASCO, ASH, and ESMO).
• Lead site‑initiation visits (SIVs) and Investigator Meetings to ensure PIs and site staff are fully aligned on study protocols.

• Education: MD or equivalent with clinical training; oncology or hematology sub‑speciality training highly preferred.
• Experience: Medical oncology/hematology fellowship with 1 to 3+ years of clinical development experience in the academic setting and/or biotech/pharmaceutical industry.
• Technical
  
  Skills:
  
  Experience in medical monitoring, clinical protocol development, and clinical database review.
• Execution Mindset: Demonstrated ability to multi‑task and execute a task independently or with minimal supervision under tight deadlines (e.g., meeting database cut targets).
• Communication: Strong and open communication skills to align internal stakeholders and external investigators.

The expected base salary range for this position is $200,000–$300,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills. While most offers typically fall within the low to mid‑point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

Syst Immune offers a comprehensive benefits package, including 100 % paid employee premiums for medical, dental, and vision coverage; STD, LTD; a 401(k) plan with a 50 % company match of up to 3 % and a vesting schedule of only 5 years; 15 PTO days per year, sick leave, and 11 paid holidays.

Syst Immune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.