Associate Scientist, Clinical Development

Biopharma Careers; San Diego (CA); On-site; USD 48,000 - 65,000; Full time

Benefits offered by this job

Annual bonus

Equity long term incentive program

Retirement savings plan with company

Paid vacation and holidays

Health benefits

Job summary

Neurocrine Biosciences is seeking a qualified professional to support clinical development in both early and late phases through registration. You will inform study design, oversee execution, maintain databases, analyze data and summarize results.

You will contribute to multidisciplinary teams by integrating medical, scientific, regulatory and commercial perspectives with emphasis on clinical trial methodology.

Qualifications

• BA/BS or MA in Data Sciences, Psychology or related field
• 2+ years of industry relevant experience
• Timely and accurate monitoring of patient data and study-related information
• Regulatory practices and drug development precedent
• Supports development of regulatory documents for filings and agency meetings
• Reviews competitor landscape and provides insights
• Abstracts, manuscripts, and regulatory document authorship
• Awareness of ICH-GCP, external regulations and procedures
• Strategic thinking to synthesize data and develop clinical strategies
• Excellent computer skills and communication skills
• Excellent project management abilities

Responsibilities

• Provides clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management
• Input to study design, protocol concepts and statistical analysis plans for high value clinical endpoint insight
• Contributes to selection and development of outcome measures for early and late stage trials
• Conducts literature research to identify optimal development paths and study designs
• Collaborates with external opinion leaders and internal clinicians to ensure appropriate study designs
• Works with study and program teams to achieve program goals and deliverables
• Monitors patient data and study-related information at clinical study sites
• Ensures data entry adherence and accuracy at sites
• Meet multiple deadlines across projects with high accuracy

Job description

Who We Are:

Neurocrine Biosciencesis a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are 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 for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than 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. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role:

Supports clinical development in early and late phases through registration. Responsibilities include informing study design, overseeing execution, maintaining databases, data analyses, and summary of results. Contributes to multidisciplinary teams through complex decision-making, integrating input from medical, scientific, regulatory and commercial perspectives with emphasis on clinical trial methodology, management and development of outcome measures. May be a resource to program teams for guidance of all matters related to analysis and communication of clinical data. May lead program discussions and data presentations internally and externally.

Your Contributions (include, but are not limited to):

• Provides clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management


• Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions


• Contributes 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


• Leverages personal subject matter experience, and conducts research into relevant literature, to identify optimal development paths, clinical study designs, and outcomes for inclusion in clinical trials


• Collaborates with external opinion leaders. internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of


• Works with study and program teams to achieve program goals and provides deliverables in approved timeframes


• Monitors patient data and study-related information related to clinical study sites and clinical trial participation


• Monitors site adherence to protocol activities and expectations and works with sites to ensure clear, concise and accurate data entry


• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

Requirements:

• BA/BS or MA in Data Sciences, Psychology or related field and 2+ years of industry relevant experience


• Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable.


• Applies best regulatory practices and drug development precedent to assigned programs


• Supports the development of regulatory documents for filings and agency meetings


• Reviews and interprets scientific knowledge of competitor landscape (molecule/indication)


• Proactive identification of issues/problems and recommend solutions


• Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)


• 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


• Strategic skills thinking skills with the ability to synthesize data, formulate, develop and execute clinical strategies


• Excellent computer skills


• Excellent communications, problem-solving, analytical thinking skills


• Excellent project management skills. May develop an understanding of other areas and related dependencies

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.

The hourly rate we reasonably expect to pay is $35.35-$47.34. 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 15% 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.