Clinical Research Director, Rare Disease

Clinical Research Director, Rare Disease

In this role you will contribute to the creation and execution of the clinical development strategy for assigned Rare Disease projects, driving clinical and scientific knowledge and advancing operational capabilities while challenging the status quo.

Responsibilities

• Draft the extended synopsis of studies, contribute to the clinical development plans (CDP), the clinical sections of integrated development plans (IDP), and oversee execution of these plans by operational units in compliance with Good Clinical Practice (GCP) and applicable laws, regulations, and standard operating procedures (SOPs).
• Represent the project in relevant teams and the protocol review committee, reviewing and commenting on the Investigator’s brochure.
• Assist with defining timelines, budgets, and contingency/risk management plans to assure successful execution of clinical trials.
• Defend the CDP before internal management committees, regulatory agencies, and alliance partners where applicable.
• Provide input into strategies to increase understanding of the drug’s mechanism of action, including the identification of biomarkers.
• Contribute expertise on an ad‑hoc basis to tasks such as evaluating potential in‑licensing candidates.

Scientific and Technical Expertise

• Strong scientific and clinical foundation in internal medicine, with knowledge in metabolism and all aspects of drug development.
• Leadership skills and the ability to collaborate effectively with external partners, regulators, and diverse internal stakeholders.
• Deep scientific, technical, and clinical expertise in internal medicine and related areas.
• Up‑to‑date knowledge of pre‑clinical, clinical pharmacology, and data relevant to the molecule of interest.
• Critically reads and evaluates relevant medical literature with deep understanding of data and status of competitive products.
• Ensures all development activities are proactively planned and targeted toward timely achievement.
• Engages with opinion leaders and consultants.

Complex Problem Solving

Ability to integrate highly complex scientific, medical, and operational information into sophisticated CDPs, using an innovative and open‑minded approach to solve complex development challenges.

Regulatory Responsibilities

• Represent the project at key regulatory agency meetings as the medical spokesperson for studies and projects.
• Ensure clinical data meets all necessary regulatory standards.
• Support registrations, label submissions, and modifications.
• Participate in Advisory Committee preparation.

Scientific Data Dissemination

• Ensure timely submission and dissemination of clinical data.
• Support the planning of advisory board meetings.
• Establish and maintain collaborations with knowledge experts.

Basic Qualifications

• Medical Doctor, PhD desirable.
• Completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).
• More than 5 years of clinical or scientific, or more than 10 years of industry experience within drug development.
• Strong scientific and academic background with deep understanding of the therapeutic area.
• Clinical research experience in rare disease drug development preferred.
• Knowledge of drug development.
• Good networking ability in a cross‑cultural environment.
• Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization.
• Performance oriented with the ability to work along agreed timelines and a focus on strategy and execution.
• Outstanding communicator; excellent problem‑solving, conflict‑resolution, and decision‑making skills.
• Fluent in English (verbal and written communication).