Executive Medical Director, Clinical Development, Pediatric Neurology

Neurocrine Biosciences

33d

About The Position

About the Role: The Executive Medical Director will be primarily responsible for developing and executing the Neurology strategy and driving clinical programs for pediatric neurological diseases like epilepsy and neurodevelopmental disorders. Specific responsibilities will include: being the clinical or program lead for the development of clinical research strategies, clinical development plans, and independent direction of Phase 1-4 clinical studies collaboratively within cross-functional project teams (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory, drug safety, CMC). Responsible for medical oversight of clinical research studies, providing necessary medical input and decisions (in Sponsor medical monitor role) to the study teams, external partners and clinical sites. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems, data analysis and final reports. Partners with Drug Safety Pharmacovigilance on adverse event reporting and safety monitoring committees as required. Coordinates and develops content for reports and submissions to regulatory or other agencies. Participates in the cross-functional Neurology Therapeutic Area Strategy Group to develop and evolve R&D strategy on new targets, research programs and platform development to support existing and emerging neurology programs, collaborating with other therapeutic areas internally and engaging with external experts as needed to leverage expertise. Collaborates with Research, Preclinical Development, and Experimental Medicine to vet and potentially develop biomarkers necessary for the most effective evaluation of novel molecules. Partners with Business Development in the assessment of external innovation.

Requirements

MD or equivalent degree with accredited residency training and board certification in Pediatric Neurology
8+ years experience in clinical drug development (Phase 1-3) in a pharmaceutical/biotechnology company, including significant experience in senior leadership role
Extensive knowledge of clinical drug development is mandatory, including knowledge of clinical development planning, US and global regulatory requirements and submission standards, study design, biostatistics, Good Clinical Practice (GCP), comfortable with oversight of internal and CRO resources in study conduct, data collection and analysis, report writing, and scientific presentation of data, across early and late development phases
Ability to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of, internal and external personnel, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel
First-hand clinical and research expertise in neurology therapeutic area and diseases
Recognition and track-record of partnering well with multiple stakeholders, eg, collaboration partners, scientific organizations, and patient advocacy organizations
Requires broad and comprehensive expertise in leading-edge theories and techniques within clinical drug development
Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations
Effectively influences internal/external business and/or industry issues that have an impact on Neurocrine
Exceptional analytical and critical thinking abilities to synthesize and communicate complex information
Sets broader picture and longer-term vision for department
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of quality and efficiency
Excellent project leadership skills to lead across functions and teams
Excellent presentation, verbal and written communication skills
Exceptional accountability, interpersonal and organizational skills, and the ability to collaborate and lead effectively in a cross-functional team environment
Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

Nice To Haves

Advanced degree (MS, PhD) in relevant scientific discipline preferred
Demonstrated success in leading clinical programs in neurological and/or rare disease, recent experience in clinical development of drugs for pediatric epilepsy and/or neurodevelopmental disorders desired.
Experience in developing various treatment modalities (small molecules and biologic/genetic therapies) desired

Responsibilities

Drive strategic direction for neurology programs during development and overseeing clinical phases.
Responsible for the design and implementation of clinical plans, data collection and assessment, and communication of results
Lead the planning and execution of clinical development projects globally to achieve company objectives in compliance with GXP and regulatory requirements
Create and foster strong relationships with external scientific leaders and investigators
Accountable to senior management in the development of strategies, research plans, budgets, and data deliverables
Support or oversee as a subject matter expert all relevant US and global regulatory submission documents in collaboration with cross-functional development teams
Lead and/or support process improvement work to ensure best practices are developed and implemented for R&D organization
Supervise the organization of monitoring procedures and collection of data
Monitor clinical trials directly and indirectly through operational teams, QA systems, CROs
Contribute to publication and presentation of data through scientific communications externally
Anticipate factors/opportunities that could impact Neurocrine's strategies and its position in the field and recommend new or innovative solutions
Manage directly or indirectly members of the clinical development organization (MDs, clinical scientists, data scientists) or other functions within a matrix environment
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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