Senior Director, Global Clinical Development

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

📋 Description

• Oversee the clinical development strategy and implementation for designated programs from proof of concept to late-stage trials and regulatory submissions.

• Offer medical and scientific guidance to cross-functional study teams.

• Ensure the design, execution, and data interpretation of clinical trials are of high quality.

• Act as the medical lead and subject matter expert for specified indications.

• Guarantee compliance of trials with GCP, regulatory standards, and internal procedures.

• Lead and contribute to clinical sections of INDs, IBs, clinical study reports, and NDAs/BLAs.

• Collaborate with regulatory affairs on interactions with global health authorities.

• Provide strategic and medical oversight for vendor and CRO relationships as well as governance committees.

• Facilitate clinical discussions with KOLs and advisory boards.

• Formulate medical monitoring plans and asset development strategies.

• Assist in publication planning and review scientific manuscripts.

• Guide and mentor junior team members.

• Support business development by conducting medical due diligence and evaluating external opportunities.

• Contribute to initiatives for continuous corporate process improvement.

⛳️ Requirements

• M.D. or D.O. degree, ideally with a background in immunology, rheumatology, or dermatology.

• Experience in management, whether direct or indirect.

• A minimum of five years of clinical research experience post-academia is preferred as a general guideline.

• Background in the pharmaceutical industry, clinical practice, and/or academic translational clinical research.

• Comprehensive knowledge of clinical medicine and/or clinical pharmacology along with related fields such as biostatistics, data management, and medical writing.

• Advanced understanding of clinical medicine and scientific principles.

• In-depth knowledge of drug development principles and the management and implementation of clinical trials.

• Thorough understanding of global regulatory requirements.

• Familiarity with marketing and commercialization aspects.

• Awareness of corporate objectives and fundamental business principles.

• Proven experience across various developmental phases, including preclinical or in-licensing evaluations, early clinical safety, proof of concept, global registration trials, and late-stage life-cycle management.

• Demonstrated experience in leading clinical aspects of regulatory interactions.

• Capability to work across different therapeutic areas and stages of clinical development.

• Proven ability to manage and inspire clinical team members, internal staff, and external investigators/consultants.

• Excellent communication and presentation skills.

• Proficient computer skills with experience in Microsoft Word, Excel, PowerPoint, and Outlook.

• Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.

• Willingness to travel approximately 30–35% of the time.

🏝️ Benefits

• Extensive medical, dental, vision, and prescription drug coverage.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement program.

• Assistance with student loans.

• Generous 401(k) matching contributions.

• Flexible time off policies.

• Paid holidays.

• Paid leave options.

• Additional company-provided benefits.

• Opportunities for incentives.