SystImmune 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). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
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, you will be responsible for the clinical oversight, medical monitoring, and execution of one or two key assets in Phase 1 to 3 clinical trials in solid tumor or hematology indications. You will act as the primary clinical development contact between sites/ principal investigators, CRO and the company, ensuring that study conduct aligns with the clinical development protocol, regulatory requirements, and safety standards. You will also have the opportunity to participate in the protocol development, clinical development plan, strategic discussion and cross alliance discussion. This will be an associate director or director level position with high leadership visibility and significant growth potential in a highly dynamic team within a rapidly growing biotech company
Key Responsibilities1. 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
Qualifications- Education: MD or equivalent with clinical training; oncology or hematology subspeciality 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.
Compensation and Benefits:
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.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also 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, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
