- Drive strategic direction for organizational plans and policies for clinical trials/research and data collection activities. Responsible for the implementation of clinical projects
- Create and foster strong relationships with investigators
- Collaborates with senior management in the development of strategies, research plans, budgets, and clinical summaries
- Monitor adherence to protocols
- Supervise the organization of monitoring procedures and collection of data
- Synthesize study-related data from multiple sources to drive study/program strategy
- Monitor clinical trials directly and indirectly through assigned CRAs and CROs
- Provide necessary input for Investigator Brochures and FDA documents including IND and NDA documents
- Collaborate on multidisciplinary project teams to deliver development goals
- Participate in and speak at professional meetings
- Prepare final study reports
- Anticipate factors that could impact Neurocrine's strategies and its position in the field and recommend new or innovative solutions
- Direct the development of protocols and study designs
- Select, develop and evaluate clinical department personnel to ensure the efficient operation of the function
- Other duties as assigned
- MD or DO required and 6+ years of experience in clinical research and development (Phase I-IV) in either a pharmaceutical/biotechnology company or a clinical research/academic environment or related experience required. and
- Extensive previous leadership experience also required
- Acts as a "trusted advisor" across the company and may be recognized as an external expert
- Provides strategy, vision and direction regarding issues that may have company-wide impact
- Requires in-depth knowledge of the functional area and business needs
- Possesses industry-leading knowledge
- Excellent organizational skills
- Excellent presentation, written and verbal communication skills
- Ability to synthesize data from multiple sources and modalities and apply advanced analytical thought and judgment
- Strong leadership, collaboration, and employee development skills
- Ability to influence others with or without authority at all levels of the organization
- Proactive, innovative, with excellent problem-solving and decision making skills
- Ability to work in a cross functional team and matrix environment
- High degree of planning ability in coordinating the activities of clinical investigations within the limits of clinical research schedules
- Extensive knowledge of federal regulations regarding clinical studies and the conduct of clinical studies
- Effective interpersonal skills (ability to be personable and establish good rapport with investigators, study coordinators, and other study personnel)
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Sr. Director/Executive Director MD, Clinical Development - San Diego, United States - Neurocrine Biosciences Inc.
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.
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 AbbVieAbout the Role:
Drives strategic organizational plans and policies for clinical trials/research and data collection activities.
Works with a multidisciplinary team involving R & D project teams, clinical project managers, business management, regulatory, and others to execute trials.
Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiate study design. Responsible for overseeing human clinical trials, phases I - IV, from a clinical perspective, for company products under development. These responsibilities include monitoring trial participant safety and quality of execution of trial by study sites. In addition, this role coordinates and develops information for reports submitted to regulatory or other agencies._
Your Contributions (include, but are not limited to):
Requirements:
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 $266,100.00-$385, 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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