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Clinical Development Biotech Jobs in Iowa (NOW HIRING)

... the clinical research needs of global biopharmaceutical, biotechnology, medical device ... Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing ...

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Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

... biotech manufacturer, API manufacturing and/or pilot plant environment highly preferred ... Client is a leading global contract development and manufacturing organization (CDMO) that provides ...

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Clinical Development Biotech information

What is clinical development in biotech?

Clinical development in biotech refers to the process of testing new drugs or therapies in human participants to determine their safety and effectiveness. This phase follows preclinical research and involves multiple stages of clinical trials, from Phase I (safety) to Phase III (efficacy and monitoring of side effects). Clinical development professionals coordinate the design, implementation, and analysis of these studies, ensuring compliance with regulatory standards. Their work is crucial in bringing innovative treatments from the laboratory to patients. Success in this field requires knowledge of medical science, regulatory guidelines, and project management.

What are the typical challenges faced by professionals working in clinical development within the biotech industry?

Professionals in clinical development for biotech companies often encounter challenges related to navigating complex regulatory requirements, managing tight timelines, and ensuring robust data quality across clinical trials. Additionally, frequent cross-functional collaboration is needed, as teams work closely with regulatory affairs, medical affairs, and data management to drive studies forward. Adapting to evolving scientific advancements and shifting project priorities are also common, so flexibility and strong communication skills are essential for success in this fast-paced environment.

What is the difference between Clinical Development Biotech vs Clinical Research Associate?

AspectClinical Development BiotechClinical Research Associate
Required CredentialsBachelor's or higher in life sciences, relevant certificationsBachelor's in life sciences, often with CRA certification
Work EnvironmentPharmaceutical/biotech companies, labs, clinical trial teamsMonitoring sites, clinical trial sites, sponsor offices
Employer & Industry UsageBiotech firms, pharmaceutical companies, CROsPharmaceutical companies, CROs, research organizations
Common Search & ComparisonYesYes

The Clinical Development Biotech role focuses on planning and managing clinical trials within biotech companies, often involving protocol development and regulatory submissions. In contrast, a Clinical Research Associate primarily monitors clinical trial sites to ensure compliance and data integrity. While both roles require similar educational backgrounds and certifications, their daily responsibilities and work environments differ, with the former being more involved in trial design and the latter in trial oversight.

What are the key skills and qualifications needed to thrive as a Clinical Development professional in biotech, and why are they important?

To thrive in Clinical Development within biotech, you need a strong background in life sciences, clinical trials management, and regulatory compliance, often supported by an advanced degree (e.g., PhD, PharmD, or MD). Proficiency with clinical trial management systems (CTMS), data analysis tools, and familiarity with ICH-GCP guidelines and FDA regulations are typically required. Strong project management, communication, and problem-solving skills help navigate complex studies and multidisciplinary teams. These competencies are essential to ensure safe, efficient, and compliant development of new therapies from concept to market.
What are popular job titles related to Clinical Development Biotech jobs in Iowa? For Clinical Development Biotech jobs in Iowa, the most frequently searched job titles are:
What job categories do people searching Clinical Development Biotech jobs in Iowa look for? The top searched job categories for Clinical Development Biotech jobs in Iowa are:
What cities in Iowa are hiring for Clinical Development Biotech jobs? Cities in Iowa with the most Clinical Development Biotech job openings:

Supply Chain Manager - Development Supply Chain Technologies

Amgen

Breda, IA โ€ข On-site

Full-time

Medical, Dental, Vision, Life, Retirement

This job post hasย expired today.ย Applications are no longer accepted.


Job description

Career CategorySupply ChainJob DescriptionJoin Amgenโ€™s Mission of Serving Patients

At Amgen, if you feel like youโ€™re part of something bigger, itโ€™s because you are. Our shared missionโ€”to serve patients living with serious illnessesโ€”drives all that we do.

Since 1980, weโ€™ve helped pioneer the world of biotech in our fight against the worldโ€™s toughest diseases. With our focus on four therapeutic areas โ€“Oncology, Inflammation, General Medicine, and Rare Diseaseโ€“ we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youโ€™ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youโ€™ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Supply Chain Manager โ€“ Development Supply Chain Technologies

What you will do

Letโ€™s do this. Letโ€™s change the world. In this vital role you will join the Development Supply Chain Technologies (DSCT) organization.ย  The DSCT team manages clinical customization in SAP/ERP to support process execution for Clinical Supply Chain Planning, Clinical Customer Service, Warehouse and Distribution. This role also supports the Business Process Owner for the clinical SAP solution in support of the clinical Order to Cash (OTC) and/or Plan to Stock (PTS) functionality and the implementation of new functional requirements and process improvements.

Responsibilities:

  • Manage assigned end-to-end processes and ensure their readiness for execution of clinical supply chain processes.
  • Partner with DTI to assist with the resolution of technical incidents utilizing the Integrated Service Management-ServiceNow (ISM-SN) application.ย  Point of contact for application issues, incidents, and troubleshooting.ย  Manage timely closure of incidents.
  • Troubleshoot technical incidents with end users utilizing both internal resources and outside organizations such as External Trial Operations (ETO).
  • Monitor iDoc failures and determine the root cause of issues.ย  Work with the business and/or DTI team to implement corrective actions.
  • Act as a change record owner to support continuous improvement initiatives.
  • Manage documentation and maintenance of clinical customization requirements to support readiness for key projects, audits, and inspections.
  • Manage audit readiness playbooks for assigned processes.
  • Interpret customersโ€™ needs to identify potential opportunities for improvements.ย  Generate Business Requirements (BRD) documents to initiate enhancements per the intake process.
  • Support development of business cases for proposed system enhancements.
  • Support and/or lead enhancement implementation. Develop project milestones, adhere to timelines, utilize project management tools such as Smartsheet, communicate issues, ensure issue resolution, and ensure change management for business end users.
  • Act as primary tester for system enhancements and upgrades, which includes script authoring/approval, data preparation, test execution, and defect resolution test approval.
  • Support training in the clinical OTC and/or PTS process at Amgen to DSC and cross functional staff.
What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Supply Chain professional we seek is an individual with these qualifications.

Basic Qualifications:

  • Doctorate or masterโ€™s degree and 2 years of SAP or IS system experience
  • OR
  • Bachelorโ€™s degree and 4 years of SAP or IS system experience
  • OR
  • Associateโ€™s degree and 8 years of SAP or IS system experience
  • OR
  • High school diploma / GED and 10 years of SAP or IS system experience

Preferred Qualifications:

  • Experience with SAP Order to Cash functionality
  • Experience with SAP Plan to Stock functionality
  • Experience with SAP Staging Tables
  • Experience with Clinical Investigational Product management in ERP systems
  • Experience with SAP Security
  • Experience with Electronic Trial Operator systems and interfaces
  • Experience with Logistics Service provider systems and interfaces
  • Experience with data acquisition tools, such as Spotfire
  • Experience with IS management tools, such as ISM - ServiceNow
  • Experience with computerized system validation testing
  • Experience with Project Management
  • Experience with Quality systems and processes such as Change Control and Deviations
What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, weโ€™ll support your journey every step of the way.

This role is paid hourly. The expected annualized salary range for this role in the U.S. (excluding Puerto Rico) is $xxx,xxx.00 to $xxx,xxx.00. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

105,010.70USD -142,073.30ย USD