Clinical Development Physician
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Overview
Schedule
Full-time
Career level
Senior-level
Remote
On-site
Compensation
$200,000-$300,000/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Job Description
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 companyKey Responsibilities
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
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.
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FAQs About Clinical Development Physician Jobs at Systimmune
What is the work location for this position at Systimmune?
This job at Systimmune is located in Princeton, NJ, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Systimmune?
Candidates can expect a pay range of $200,000 and $300,000 per year.
What employment applies to this position at Systimmune?
Systimmune lists this role as a Full-time position.
What experience level is required for this role at Systimmune?
Systimmune is looking for a candidate with "Senior-level" experience level.
What benefits are offered by Systimmune for this role?
Systimmune offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Paid Holidays, Paid Vacation, Paid Sick Leave, 401k Matching/Retirement Savings, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Systimmune?
You can apply for this role at Systimmune either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.