Sr. Medical Director MD, Immunology

Neurocrine Biosciences • San Diego, CA

1d • Onsite

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline. This role serves as a medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies. The position involves working with cross-functional project teams to create and execute clinical development plans and strategies for product approvals. The Medical Director will provide expert medical advice to advance the development portfolio and help navigate the drug development landscape, collaborating with Research and Preclinical Development to develop necessary biomarkers for early clinical development.

Requirements

• MD or DO (or equivalent) degree in a relevant clinical specialty for the therapeutic area required.
• 4+ years of 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 to supervise lower levels and/or lead 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.

Nice To Haves

• Recognized Internal thought leader and deep expertise in a discipline
• Previous experience with developing and implementing policies and processes

Responsibilities

• Develops clinical development strategies and is accountable for the study design of clinical trials.
• Leads the preparation of clinical study synopses and is a major contributor to the writing of protocols/major amendments.
• Designs data collection systems, interprets clinical data, and prepares final clinical study reports.
• Engages with external experts and organizations as needed.
• Represents Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead.
• Accountable and responsible for medical input to integrated development plans and the clinical development plans that underpin them.
• Collaborates cross-functionally to support medical activities for clinical studies.
• Provides medical leadership to the Program Team and is accountable and responsible for driving the execution of the clinical development plan.
• Develops and implements study protocols in conjunction with a multidisciplinary Development Team.
• Assists in the identification and selection of clinical investigators and maintains appropriate communication and professional relationships as Sponsor medical monitor/representative.
• Conducts medical assessment and disposition of adverse events and evaluates the safety of clinical compounds.
• Oversees the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations.
• Identifies resource requirements, leads budget planning and personnel forecasting for clinical research programs.
• Is a key contributor in the recruitment, training, and development of clinical teams.
• Identifies and selects clinical consultants as needed.
• Leads the analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences.
• Works with Medical Affairs and external opinion leaders to secure new collaborators and present trial results.
• Interfaces with Research, Product Development, and Business Development to assess new product opportunities, develop clinical research strategy, and product development plans.
• Performs other duties as assigned.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree