Associate Scientific Director, Clinical Pharmacology

📋 Description

• • Serve as a pivotal member of program and study teams, offering strategic leadership and deep expertise in clinical pharmacology throughout the entire drug development lifecycle, from discovery to post-market.
• • Provide essential clinical pharmacology input to cross-functional teams, identifying and leveraging opportunities where advanced modeling and simulation techniques can significantly enhance the understanding of drug behavior, including pharmacological activity, efficacy, and safety profiles.
• • Spearhead the development and meticulous implementation of comprehensive clinical pharmacology development plans, ensuring alignment across strategic, scientific, translational, and clinical considerations.
• • Proactively define critical milestones and decision points within the clinical pharmacology development strategy, critically assessing potential risks and formulating robust mitigation strategies to ensure project success.
• • Lead the end-to-end execution of clinical pharmacology studies, from design and oversight to rigorous analysis and interpretation of results, translating findings into actionable recommendations for program advancement.
• • Conduct hands-on, in-depth quantitative analysis of complex pharmacological and pharmacokinetic/pharmacodynamic (PK/PD) data, effectively communicating findings and their implications to multidisciplinary project teams.
• • Take the lead in authoring and contributing significantly to the clinical pharmacology sections of key regulatory documents, ensuring clarity, accuracy, and compliance.
• • Act as the primary subject matter expert and lead representative in crucial interactions with Health Authorities, preparing and presenting scientific and strategic information effectively.
• • Foster strong collaborative relationships with internal and external stakeholders, including cross-functional partners, external consultants, key opinion leaders, and vendors, ensuring alignment and optimal utilization of expertise.
• • Drive program and study teams towards achieving defined goals, ensuring the timely delivery of high-quality clinical pharmacology deliverables in accordance with approved timelines.
• • Maintain a cutting-edge understanding of evolving regulatory landscapes, best practices in quantitative and clinical pharmacology methodologies, and emerging trends in drug development precedent, ensuring Biogen remains at the forefront of innovation.
• • Contribute to the strategic direction of the West Coast Hub's focus on developing novel targeted therapies for severe immune-mediated diseases, aiming for outsized clinical impact and accelerated development timelines.
• • Integrate knowledge of clinical and quantitative pharmacology to optimize and provide scientific rationale for dosage regimens and study designs, crucial for maximizing therapeutic benefit and minimizing risk.
• • Ensure that all clinical pharmacology activities are conducted in adherence to the highest scientific and ethical standards, contributing to the development of life-changing medicines.
• • Play a key role in shaping the future of drug development at Biogen by contributing to the application of Model-Informed Drug Development (MIDD) principles and strategies.
• • Mentor and guide junior team members, fostering a culture of scientific rigor, continuous learning, and collaborative problem-solving within the clinical pharmacology group.
• • Prepare and deliver compelling presentations at scientific conferences and advisory boards, disseminating key findings and contributing to the broader scientific community.
• • Collaborate with translational science teams to ensure seamless integration of preclinical pharmacology data into clinical development strategies.
• • Oversee the selection and management of external vendors and consultants involved in clinical pharmacology studies and analyses, ensuring quality and efficiency.
• • Contribute to the strategic planning and budgeting for clinical pharmacology activities within assigned programs.
• • Ensure compliance with all relevant company policies, procedures, and regulatory requirements throughout the drug development process.