Sr. Medical Director MD, Immunology

About the Role

Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies while working with cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety) creation and execution of clinical development plans and in the development of strategies that will ultimately lead to approvals of Neurocrine's products. Provide expert medical advice to advance the development portfolio and will help the company navigate the complex drug development landscape. Works closely with Research and Preclinical Development to develop biomarkers necessary for the most effective evaluation of novel molecules in early clinical development.

Your Contributions (include, but are not limited to)

• For assigned programs, develops clinical development strategies and accountable for the study design of clinical trials in Development, leading on the preparation of clinical study synopses and being a major contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical data, and the preparation of final clinical study reports.
• Engages with external experts and organizations as needed to achieve these aims
• Represents Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead.
• Accountable and responsible for the medical input to integrated development plans prepared by the Program Team and the clinical development plans that underpin them.
• Collaborate cross-functionally to support medical activities for clinical studies
• Provides medical leadership to the Program Team.
• Accountable and responsible for driving the execution of the clinical development plan
• Develops and implements study protocols in conjunction with a multidisciplinary Development Team
• Assist in the identification and selection of clinical investigators for clinical trials and maintain appropriate communication and professional relationships as Sponsor medical monitor/representative
• Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies; Oversee the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations
• Identify resource requirements, leads budget planning and personnel forecasting for clinical research programs; key contributor in the recruitment, training and development of the clinical teams, as well as Identify and select clinical consultants as needed
• Leads the analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences
• Work with Medical Affairs and external opinion leaders to secure new collaborators and present trial results
• Interface with Research, Product Development and Business Development to assess new product opportunities, develop clinical research strategy and product development plans
• Other duties as assigned

Requirements

• MD or DO (or equivalent) degree in relevant clinical specialty for the therapeutic area required
• 4+ years clinical experience with broad bio/pharmaceutical/CRO industry experience in drug development
• Accredited residency training and board certification preferred
• Recognized Internal thought leader and deep expertise in a discipline
• Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area
• Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations
• Influences internal/external business and/or industry issues that have an impact on Neurocrine
• Strong mentoring skills and leadership abilities supervise lower levels and/or leads indirect teams
• Proven ability to translate strategy into tactical plans and drive outcomes
• Must be flexible, adaptable, self-motivated, able to prioritize, and able to manage/progress a large volume of work with minimal supervision
• Strong interpersonal skills and outstanding collaborative skills; proven track record and success in building relationships and having scientific discourse with medical and scientific experts
• Outstanding oral and written communication skills, with close attention to detail; ability to translate complex scientific concepts into simple language tailored for different audiences
• Demonstrated success with project management
• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems
• Deep knowledge and understanding of the drug development process including technical, business, and regulatory issues
• Proven track record working with regulatory agencies and providing clinical leadership for the filing of INDs, NDAs, or other similar government filings
• Strong knowledge of Good Clinical Practice, regulatory procedures relevant to investigational drug development
• Strong knowledge in translational medicine and biomarker evaluation, clinical study execution, regulatory requirements and documents, study design, biostatistics, data analysis, report writing, and scientific presentation of data
• Able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel
• Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group
• Has successfully driven program strategy, launch and project management within Clinical Development
• Previous experience with developing and implementing policies and processes