Executive Clinical Medical Director (MD and/or Ph.D)-Psychiatry (Must be based in CA, prefer San Diego)

Clinical Group                ·                US CA San Diego (On site)            ·           Full-time

Remote type: On-Site
Locations: US CA San Diego
Time type: Full time
Posted on: July 15, 2023
Job Requisition ID: R3893

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose – to relieve suffering for people with great needs, but few options.

What We Do:

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. *in collaboration with AbbVie

About the Role:

Formulates Clinical Development strategies and long-term plans for therapeutic area(s). Oversees and directs Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety). I Primary interface with Research and Business Development to assess new product opportunities, potential fit within current clinical development strategies and plans and develop/alter clinical research strategies and product development plans as needed.

Your Contributions (include but are not limited to):

• Contributes to development of vision and strategic direction of the Clinical Development function
• Oversees the direction of Phase 1-3 Clinical Trials for assigned therapeutic area(s) the clinical development in accordance with Neurocrine SOPs and GCP guidance
• Oversees development of study protocols partnering with the Development Team
• Manages overall process for identification and selection of clinical investigators for clinical trials
• Maintain appropriate communication and professional relationship with NBI Clinical Investigators. Collaborate with peers, business leaders, account leaders and internal and external partners
• Conduct medical assessment and disposition of adverse events (in conjunction with Medical Director if non-physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies
• Oversee the clinical trials program in conjunction with the Clinical Operations
• Present results of clinical studies to senior level internal and external audiences
• Sponsor and/or participate on multidisciplinary project teams
• Recommend resource requirements, significantly contribute in budget planning and personnel forecasting for clinical research programs
• Oversee the recruitment, training and development of the clinical teams
• Leads the clinical consultant identification process. Approve the selection of clinical consultants. Seen as an industry expert and collaborates with external opinion leaders. internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes
• Sets vision and long-term strategy and responsibility for all submissions and interactions with the FDA and other regulatory authorities
• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
• Maintains knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing
• Reviews scientific writing and clinical study reports and related documents
• Provide periodic status updates and effectively communicate with Senior Management Team
• Serve as an industry leader and expert and creates formal networks with key decision makers. Serve as external spokesperson for the organization
• Other duties as assigned

Requirements:

• MD and/or PhD with specialty training appropriate to therapeutic area and 12+ years experience in clinical drug development (Phase 1-4) in a pharmaceutical/biotechnology company, including significant experience in senior leadership role. Prior experience with developing clinical development strategy and planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing, and scientific presentation of data. Prior experience working with CRO is a plus OR
• MD with specialty training appropriate to therapeutic area and 8+ years of similar experience noted above.
• Extensive knowledge of clinical drug development is mandatory, including knowledge of clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing, and scientific presentation of data
• 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
• Experience in developing medicines for Mood Disorders, Schizophrenia and other psychiatry diseases
• Experience with Neuroimaging (fMRI, PET), Biomarkers , EEG techniques and drug development
• Recognized as “guru” or external expert in a strategic job function
• Requires broad and comprehensive expertise in leading-edge theories and techniques within a strategic job function
• 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
• Exceptional analytical thinking, influencing skills
• 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 accuracy and efficiency
• Excellent project leadership skills to mentor lower levels and/or leads indirect teams
• Excellent presentation, verbal and written communication skills
• Exceptional accountability, interpersonal and organizational skills, and the ability to work in a cross-functional team environment
• Ability to apply advanced analytical thought and judgment
• Proactive, innovative, with excellent problem-solving/decision making skills

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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.

The annual base salary we reasonably expect to pay is $226,600.00-$337,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. 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.

Please click here to apply.