N

Neurocrine Biosciences

Develops and markets neurology-focused therapies

Senior Medical Director - Clinical Development, Obesity

Biology & BiotechConfirmed live in the last 24 hours
Full-timeSan Diego, CA, USAIn-person

About the Job

Requirements

  • An MD or DO (or equivalent) degree in a relevant clinical specialty for the therapeutic area is required, together with 4 or more years of clinical experience and broad biopharmaceutical, pharmaceutical, or contract research organization industry experience in drug development.
  • Accredited residency training and board certification are preferred.
  • Demonstrated deep expertise in clinical development and comprehensive understanding of the drug development process, including regulatory, technical, and business considerations.
  • A proven track record providing clinical leadership for Investigational New Drug applications, New Drug Applications, or other regulatory submissions and interactions with global regulatory agencies.
  • Strong knowledge of Good Clinical Practice, regulatory procedures, translational medicine, biomarker development, study design, biostatistics, and data interpretation.
  • Demonstrated success leading cross-functional, matrixed teams and managing external contract research organizations and vendors, particularly in small or agile organizations.
  • Experience driving program strategy from early development through late-stage execution.
  • Strong mentoring and people leadership skills, with experience leading direct and indirect teams.
  • Proficiency with standard business and clinical documentation tools, including word processing, spreadsheets, presentations, databases, and archiving systems.

Responsibilities

  • Develop and lead clinical development strategies for assigned obesity programs, with accountability for study design and medical integrity of clinical trials across Phase 1–3.
  • Serve as the Program/Therapeutic Medical Lead on cross-functional Program Teams, providing medical leadership and clinical input into integrated development plans.
  • Drive execution of the clinical development plan, ensuring alignment with corporate objectives, regulatory strategy, and scientific rationale.
  • Translate clinical strategy into actionable study designs and operational plans that deliver high-quality data and meaningful outcomes.
  • Lead preparation of clinical study synopses and contribute substantially to protocols, major amendments, and clinical study reports.
  • Oversee the design of data collection strategies and ensure appropriate interpretation and integration of clinical data.
  • Partner with Clinical Operations to oversee clinical trial execution in accordance with company standard operating procedures, Good Clinical Practice, and applicable regulatory requirements.
  • Conduct medical assessment and disposition of adverse events in collaboration with Drug Safety, and provide ongoing evaluation of benefit–risk throughout clinical development.
  • Collaborate with internal stakeholders to support study activities requiring medical expertise.
  • Engage external experts, investigators, and key opinion leaders to inform strategy, optimize trial design, and advance programs.
  • Assist in identifying and selecting clinical investigators and serve as Sponsor medical monitor/representative.
  • Work with Medical Affairs and external partners to communicate clinical data and establish new collaborations.
  • Lead analysis, interpretation, and presentation of clinical study results to internal and external audiences.
  • Provide strategic direction for scientific disclosures, including conference abstracts, presentations, and peer-reviewed publications.
  • Partner with Research and Translational Medicine to define biomarker strategies that enhance early clinical evaluation and decision-making.
  • Interface with Research, Product Development, and Business Development to assess new product opportunities and shape clinical research strategies.
  • Identify resource needs and contribute to budget planning, personnel forecasting, and development of clinical teams.
  • Recruit, mentor, and develop clinical staff, and identify and manage external consultants and contract research organizations.
  • Contribute to the development and implementation of clinical development policies, processes, and best practices.

About the Company

Neurocrine Biosciences

Develops and markets neurology-focused therapies

Neurocrine Biosciences develops and commercializes medicines for neurological and endocrine diseases. Its work centers on discovering and developing treatments, with INGREZZA (valbenazine) approved to treat adults with tardive dyskinesia and a pipeline of other drug candidates in various clinical stages. The company earns revenue from sales of approved medicines and from milestones and royalties from collaborations with partners. By focusing on both neurological and endocrine conditions, Neurocrine targets patients and healthcare professionals seeking therapies for conditions such as tardive dyskinesia, Parkinson's disease, and endometriosis. Its main goal is to bring therapies to market through development and commercialization, supported by ongoing research across its clinical programs to address unmet medical needs in these areas.

Company size
1,001-5,000
Company stage
IPO
Headquarters
San Diego, CA
Founded
1992

Recently Posted Jobs

Explore more opportunities at Neurocrine Biosciences

See more jobs