Associate Director / Director, Clinical Science

Who we are :

MBrace Therapeutics is an oncology company developing first-in-class antibody drug conjugates (ADCs) directed to novel targets. Its overarching goal is to improve the lives of cancer patients .

Job Description

Reporting to the Senior Vice President of Clinical Development, the Associate Director / Director Clinical Science will oversee all aspects of clinical research studies. You will be responsible for designing, developing, and implementing clinical trials to ensure they are conducted in an ethical and efficient manner. This role also ensures that all research studies comply with regulatory requirements.

Essential Duties and Responsibilities

• Lead the clinical science strategy and execution for assigned therapeutic programs or products within the biotechnology and pharmaceutical industry.
• Provide scientific and clinical expertise to guide clinical trials' design, conduct, and interpretation, ensuring alignment with strategic objectives and regulatory requirements.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and translational medicine, to develop and implement integrated clinical development plans.
• Oversee the development of clinical protocols, investigator brochures, informed consent forms, and other study-related documents.
• Collaborate with Clinical Operations to oversee clinical trial operations, including site selection, patient recruitment, monitoring, and data management, to ensure timely and successful study completion.
• Analyze clinical trial data and collaborate with biostatistics and data management teams to generate insights and support regulatory submissions.
• Serve as the primary clinical science liaison with investigators, key opinion leaders, and external partners, fostering productive relationships and advancing scientific understanding.
• Contribute to the preparation of regulatory submissions, including INDs, NDAs, and BLAs, by providing clinical science expertise and supporting document development and review.
• Stay abreast of scientific and clinical advancements in relevant therapeutic areas, including competitive landscape analysis and emerging trends, to inform strategic decision-making.
• Interpret and communicate clinical information, including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge and support a robust clinical development strategy
• Identify, qualify, manage, and maintain relations with clinical trial sites—including collaborating with Principal Investigators, CROs, and field teams—to develop robust study protocols, drive site selection, and promote robust patient recruitment programs
• In cooperation with Clinical Operations and Finance, develop and effectively manage the annual budget for clinical activities
• Write, review, and / or approve clinical project deliverables including investigational product labeling / kitting, Pharmacy Manuals, Lab Manuals, informed consent, regulatory submissions / approvals, site activation materials, monitoring plan and tools, CRF's, DMP, edit checks, safety plans, close-out plans, CSRs and SOPs
• Collaborate with the regulatory team to deliver regulatory documents and respond to any health authority questions or comments on time

Qualifications :

Salary Range : $165,000-215,000

MBrace Therapeutics is an Equal Opportunity Employer (EOE) – we celebrate diverse experiences and welcome applicants who meet the minimum requirements. All applicants must be legally authorized to work in the US without sponsorship.

This role is NOT open to agencies; please do not send emails or make phone calls.