Company Description

Biotech Consulting Group is an award-winning, data-focused consulting firm serving the pharmaceutical, biotech, and medical device industries. The organization specializes in addressing complex clinical trial data and regulatory submission challenges using a rigorous scientific approach. Its teams transform intricate data into clear, compelling submissions that align with stringent global regulatory standards. With strong industry experience and a commitment to data-driven drug development, Biotech Consulting Group provides strategic guidance that helps clients advance therapies efficiently and responsibly. Professionals joining the group can expect a collaborative, high-performance environment focused on quality, integrity, and innovation. Role Description The Clinical Lead, Lupus will oversee clinical activities for lupus studies, ensuring scientific integrity, patient safety, and regulatory compliance across designated programs. This contract, remote role includes leading protocol development and review, managing study-related documentation, and providing clinical oversight for trial conduct and data interpretation. The Clinical Lead will collaborate closely with cross-functional teams—such as biostatistics, data management, regulatory, and medical writing—to guide endpoint selection, support study design decisions, and contribute to submission-ready materials. Daily responsibilities include reviewing clinical data for accuracy and consistency, addressing study-related medical questions, supporting risk/benefit assessments, and participating in internal and external meetings with sponsors and key stakeholders. The role also involves staying current with lupus clinical guidelines and emerging therapies to inform strategic planning and evidence generation.

Qualifications

Clinical expertise in autoimmune diseases, preferably lupus, with experience in clinical trial design, execution, and oversight. Strong background in interpreting complex clinical and biomarker data, including familiarity with statistical outputs and safety profiles. Proven ability to collaborate with cross-functional teams (clinical operations, biostatistics, data management, regulatory, and medical writing) in a remote setting. Excellent written and verbal communication skills, including experience presenting clinical findings to internal stakeholders and external partners. Advanced degree in life sciences, medicine, pharmacy, or a related field (MD, DO, PhD, PharmD, or equivalent preferred). Solid understanding of ICH-GCP, relevant regulatory requirements, and good clinical practice in global drug development. Demonstrated ability to work independently, manage multiple priorities, and meet deadlines in a contract, remote environment. Prior experience with regulatory submissions (e.g., INDs, NDAs, BLAs or equivalent) and interaction with regulatory authorities is advantageous. Experience with lupus or other autoimmune clinical programs in the pharmaceutical, biotech, or CRO setting is strongly preferred.