Associate Director, Clinical Development – Immunology

This is a fully remote position, open to applicants in United States.

📋 Description

• Participate in the design and implementation of clinical trials for various Immunology programs, with an emphasis on early-phase (I-II) studies in autoantibody-driven diseases like myasthenia gravis and CIDP.

• Collaborate with clinical operations, biostatistics, data management, regulatory, and safety teams to promote early-phase development programs.

• Assist in the design, development, and execution of clinical trial protocols for early-phase neuroimmunology studies.

• Ensure patient safety by providing medical monitoring, clinical execution, and oversight of clinical studies.

• Act as a liaison for CROs and investigators, addressing protocol-related inquiries.

• Offer scientific therapeutic expertise to both internal and external stakeholders.

• Aid in data interpretation and clinical reporting for early-phase clinical studies.

• Assist in preparations for health authority interactions and responses to regulatory inquiries.

• Contribute scientific content to clinical protocols and other clinical development documentation.

• Support risk mitigation strategies and provide clinical insights for safety management plans.

• Help generate scientific content for protocols, amendments, investigator brochures, clinical study reports, and briefing documents.

• Integrate considerations of disease burden, feasibility, and patient experience into study designs.

• Keep abreast of the external neuroimmunology and autoimmune disease landscape, including competitive intelligence, care standards, and scientific advancements.

• Provide clinical insights to early-stage research initiatives, external collaborations, and due diligence efforts.

• Report to the Sr Director Clinical Development Lead Immunology and Indications Expansion (WCH).

⛳️ Requirements

• MD/DO (or international equivalent) or PharmD with relevant experience is required.

• 0-2+ years of experience in the biotech/pharmaceutical industry, along with additional experience in academic or clinical research.

• Prior experience in a medical monitoring or investigator/sub-investigator position is essential.

• Experience in clinical study execution and/or oversight and collaboration with R&D partners is required.

• Strong written and verbal communication abilities are necessary.

• A deep scientific and clinical understanding of neuroimmunology/autoimmune disorders is needed.

• Capability to manage multiple priorities in a fast-paced environment is essential.

• Willingness to travel domestically and internationally as business needs dictate.

• Preferred subspecialty experience in neurology or neuromuscular medicine, or prior drug development experience in neuromuscular or neuroimmunology diseases.

• Relevant experience in disease areas such as Myasthenia Gravis, CIDP, neuroimmunology, or other immune-mediated conditions is preferred.

• Understanding of regulatory requirements related to drug development is preferred.

• An established network of global Key Opinion Leaders (KOLs) is preferred.

• Open to remote talent based in the U.S., with a preference for candidates near the West Coast site in California.

🏝️ Benefits

• Medical, Dental, Vision, & Life insurances.

• Fitness & Wellness programs, including fitness reimbursement.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation along with additional end-of-year shutdown time off (Dec 26-Dec 31).

• Up to 12 company-paid holidays plus 3 paid days off for Personal Significance.

• 80 hours of sick time each calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Participation in Employee Resource Groups.

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Remote work arrangement.