Executive Director/Senior Director, Medical Director MD – Immune or Neuro Immune

Role Summary

Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies in immune-driven and/or neuro immune-driven diseases, while working with cross-functional project teams to create and execute clinical development plans that will lead to approvals of Neurocrine's products. Experience with biomolecules, such as therapeutic antibodies, is required. Provide expert medical advice to advance the development portfolio and navigate the complex drug development landscape. Work closely with Research and Preclinical Development to develop biomarkers for evaluating novel molecules in early clinical development.

Your Contributions

• For assigned programs, develop clinical development strategies and be accountable for study design of clinical trials in Development, leading the preparation of clinical study synopses and contributing to writing of protocols/major amendments, data collection systems, interpretation of clinical data, and final clinical study reports. Engage with external experts and organizations as needed.
• Represent Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead. Be accountable for medical input to integrated development plans and clinical development plans; collaborate cross-functionally to support medical activities for clinical studies.
• Provide medical leadership to the Program Team and drive execution of the clinical development plan.
• Develop and implement study protocols with a multidisciplinary Development Team.
• Assist in identifying and selecting clinical investigators for trials and maintain communications as Sponsor medical monitor/representative.
• Conduct medical assessment and disposition of adverse events and evaluate safety of clinical compounds during ongoing studies.
• Oversee the clinical trials program in conjunction with Clinical Operations in accordance with SOPs, Good Clinical Practice, and applicable regulations.
• Identify resource requirements, lead budget planning and personnel forecasting for clinical research programs; contribute to recruitment, training, and development of clinical teams; identify and select clinical consultants as needed.
• Lead 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 collaborations and present trial results.
• Interface with Research, Product Development and Business Development to assess new product opportunities and develop clinical research strategy and product development plans.
• Other duties as assigned.

Requirements

• MD/DO and 6+ years of experience with clinical practice and Medical Affairs or related pharmaceutical consulting capacity.
• Preferred experience: Clinical Practice in Psychiatry, Neurology or Movement Disorders.
• Recognized internal thought leader with deep expertise in immune-driven diseases.
• Broad, deep expertise in leading-edge theories and techniques for the functional area.
• Ingenuity and creativity in problem analysis and resolution in complex/novel situations.
• Ability to influence internal/external business or industry issues affecting Neurocrine.
• Strong mentoring and leadership abilities; capable of supervising lower levels or leading indirect teams.
• Proven ability to translate strategy into tactical plans and drive outcomes.
• Flexible, adaptable, self-motivated; able to prioritize and manage a large volume of work with minimal supervision.
• Strong interpersonal and collaborative skills; proven track record building relationships with medical and scientific experts.
• Excellent oral and written communication; ability to translate complex concepts for diverse audiences.
• Demonstrated success in project management.
• Proficiency with word processing, spreadsheets, databases, presentation software, and filing systems.
• Deep knowledge of the drug development process including technical, business, and regulatory issues.
• Proven track record with regulatory agencies and leadership for filing INDs, NDAs, or similar filings.
• Strong knowledge of Good Clinical Practice and regulatory procedures for investigational drug development.
• Strong knowledge in translational medicine, biomarker evaluation, clinical study execution, regulatory requirements, study design, biostatistics, data analysis, report writing, and scientific presentation of data.
• Ability to operate effectively in a multi-level matrix environment with cross-functional teams and external parties.
• Experience managing interactions with external CROs and consultants; track record in program strategy and project management in Clinical Development.
• Experience developing and implementing policies and processes.

Education

• MD/DO degree required.