Medical Director, Drug Safety and Pharmacovigilance
About Us
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
As the Medical Director, Drug Safety and Pharmacovigilance, you will play a key role in ensuring the safety of our investigational products.
Reporting to the Senior Medical Director, Drug Safety and Pharmacovigilance, this position will work independently on assigned safety activities while also assisting in the completion of complex tasks, such as pharmacovigilance analyses, signal detection, risk management, and regulatory submissions. You will collaborate closely with the internal pharmacovigilance science and operations to ensure effective cross-functional execution of safety science, operational excellence, and compliance across the DSPV organization. A strong foundation in clinical medicine and pharmacovigilance, excellent analytical and communication skills, and a passion for improving patients’ lives through rigorous safety science is ideal.
We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- Serve as the safety physician lead for designated Dianthus’s product.
- Conduct medical review of individual case safety reports (ICSRs), including seriousness, expectedness, and causality assessment, ensuring appropriate coding and compliance with global regulations.
- Perform aggregate data analysis and interpretation.
- Author and provide medical input to safety related regulatory documents such as periodic safety reports (e.g., DSURs, ASRs, PSUR, PADERs, etc.) or other deliverables as appropriate.
- Contribute to / lead safety review committee activities, including individual and aggregate data analyses, signal detection and evaluation, interpretation of safety signals and trends, and documentation and communication of safety assessments.
- Contribute to relevant clinical and regulatory documents, such as study protocols, investigator brochures, statistical analysis plan, and clinical study reports.
- Collaborate with relevant functions such as clinical development, data management, regulatory affairs, biostatistics, and medical affairs on relevant safety issues.
- Review and summarize relevant scientific and clinical literature to support safety evaluations and regulatory submissions
- Support the senior medical director / designee on complex pharmacovigilance tasks/activities such as integrated safety analyses, benefit–risk assessments, and development of risk management strategies.
- Support internal and external pharmacovigilance audits and regulatory inspections.
- Collaborate closely with the pharmacovigilance scientist and operation to ensure high-quality case processing, database oversight, compliance monitoring, and preparation of relevant safety deliverables.
- Stay current with global pharmacovigilance regulations, guidelines, and best practices.
- Additional tasks as needed.
Experience
MD, DO, or U.S. equivalent required, along with at least 3 years of industry pharmacovigilance (PV) experience as a safety physician.
- Experience in neurology, immunology, and rare disease preferred.
- Experiences in early and late phase clinical trials preferred.
- Strong pharmacovigilance with signal management (e.g., signal detection, evaluation, assessment).
- Ability to lead and conduct individual safety case report processing, including triage, medical review and safety data summarization and analysis.
- Competent knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection.
- Knowledge of and ability to apply pre- and post-marketing drug safety standards.
- Proficient with safety databases (Argus preferred) and safety coding dictionaries (e.g., MedDRA, WHODRUG).
- Excellent problem-solving, analytical thinking skills.
- Excellent oral, written and presentation skills.
- Excellent interpersonal skills and ability to work effectively as part of a team/ Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
- Ability to prioritize, respond to directives, and work in a fast-paced and changing environment remotely.
- Get-it-done-roll-up-your-sleeves attitude and commitment to putting patients first.
- Leadership skills, including a collaborative and team-oriented approach.
- Ability to function independently at a high level in a team setting, whether leading the group or acting as an individual contributor.
- Trustworthy with the highest level of integrity; committed to ethics and science standards.