- Directs Phase 1-3 Clinical Trials for the clinical development in accordance with Neurocrine SOPs and GCP guidance.
- Develops and implement study protocols consistent with the Development Team direction.
- Assists in the identification and selection of clinical investigators for clinical trials.
- Maintains appropriate communication and professional relationship with NBI Clinical Investigators.
- Conducts assessment and disposition of adverse events (in conjunction with Medical Director if non-physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies.
- Leads effort within clinical development program teams on selection of established and development of novel outcome measures in the context of clinical trials in early and late stages of clinical development
- Oversees the clinical trials program in conjunction with the Clinical Operations.
- Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Sr. Management.
- Participates on multidisciplinary project teams.
- Identifies resource requirements, assists in budget planning and personnel forecasting for clinical research programs.
- Assists in the recruitment, training and development of the clinical teams to ensure efficient operation of the function.
- Identifies and selects clinical consultants. 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
- Provides or assists in the scientific writing and review of clinical study reports and related documents.
- Provides periodic status updates and effectively communicate with Senior Management Team.
- Responsible for developing the infrastructure to support advanced clinical trials.
- Sets strategy for regulatory processes with 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
- Other duties as assigned.
- MS degree in Life Sciences or related field and 10+ years of related experience in industry with expertise in the areas of drug development, operations and strategic plannings. Specialty training appropriate to therapeutic area in addition to experience in clinical drug development (Phase 1-4) in a pharmaceutical/biotechnology company. Prior experience working with CRO is a plus. Extensive previous managerial experiences also required OR
- PharmD or PhD degree preferred and 7+ years of similar experience noted above OR
- MD a plus and 2+ years of similar experience noted above
- Extensive knowledge of clinical drug development is mandatory and should include prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing, and scientific presentation of data
- Must be able 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
- Expertise in the areas of drug development, operations and strategic planning
- Expertise in submissions from investigational new drug through new drug application filings and managing a product from pre-clinical through all clinical phases and product launch
- Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
- Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
- Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
- Strong interpersonal and communication skills as well as strong organizational and team leadership skills are required
- Ability to apply advanced analytical thought and judgment
- Strong leadership, coaching, employee development skills
- Ability to influence others with or without authority at all levels of the organization
- Proactive, innovative, with good problem-solving skills
- Ability to work in a cross functional team and matrix environment
- Excellent written, presentation, and verbal communication skills
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Director, Clinical Development- San Diego based - Neurocrine Biosciences
Description
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:
Responsible for developing strategy and plans for Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety). As needed, interfaces with Research and Business Development to assess new product opportunities, develop clinical research strategy and product development plans.
Your Contributions (include, but are not limited to):
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 $190,900.00-$276, 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.
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