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

Neurocrine Biosciences•San Diego, CA

19d

About The Position

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 a 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. Experience with biomolecules, such as therapeutic antibodies, is required. 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.

Requirements

MD/DO and 6+ years of experience with a combination of clinical practice experience and Medical Affairs or related pharmaceutical consulting capacity.
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

Nice To Haves

Clinical Practice experience in Psychiatry, Neurology or Movement Disorders.
Recognized Internal thought leader and deep expertise in immune-driven diseases

Responsibilities

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.

Benefits

Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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