Full-Time

Executive Medical Director

Clinical Development, MD

Confirmed live in the last 24 hours

Neurocrine Biosciences

Neurocrine Biosciences

1,001-5,000 employees

Biotechnology
Healthcare

Compensation Overview

$294.1k - $425.9kAnnually

+ Bonus + Equity Incentive Program

Senior, Expert

San Diego, CA, USA

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Requirements
  • MD/DO and 6+ years of experience with broad bio/pharmaceutical/CRO industry experience and 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
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
Neurocrine Biosciences

Neurocrine Biosciences

View

Company Stage

IPO

Total Funding

N/A

Headquarters

San Diego, California

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Positive Phase 2 data for NBI-1117568 in schizophrenia and the launch of INGREZZA SPRINKLE highlight Neurocrine's innovative pipeline and commitment to addressing unmet medical needs.
  • The FDA's acceptance of crinecerfont's New Drug Applications with Priority Review could lead to a significant market breakthrough if approved.
  • Recent investments and executive appointments suggest strong confidence in the company's future growth and strategic direction.

What critics are saying

  • The pharmaceutical industry is highly competitive, and Neurocrine must continuously innovate to maintain its market position.
  • Regulatory hurdles, such as FDA rejections, could delay product launches and impact financial performance.

What makes Neurocrine Biosciences unique

  • Neurocrine Biosciences is pioneering in the treatment of congenital adrenal hyperplasia (CAH) with crinecerfont, a first-in-class therapy that hasn't seen innovation in 70 years.
  • The company offers unique formulations like INGREZZA SPRINKLE, addressing specific patient needs such as dysphagia, which sets them apart in the pharmaceutical landscape.
  • Their focus on rare and serious endocrine disorders, combined with successful clinical trials, positions them as a leader in niche therapeutic areas.

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