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AVAILABLE JOBS

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Clinical Pharmacology Director - Home-Based (US)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

  • Provide clinical pharmacology support for programs through the worldwide marketing application filing, including supportive registration documents and presentations.
  • Review and prepare documents for regulatory submission, including clinical development plans, Investigator’s Brochure, and the Clinical Pharmacology section of INDs, CTAs, and/or NDAs.
  • Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, documents for regulatory meetings, NDA/BLA/MAA.
  • Participate in designing the overall clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.
  • Write and review scientific documents, such as Clinical Study Protocols, Standard Operating Procedures (SOPs), Statistical Analysis Plans, and Clinical Study Reports
  • Collaborate with cross-functional teams, including clinical, clinical operations, regulatory affairs, and biostatistics, to ensure the successful execution of clinical trials
  • Ensure the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
  • Development and execution of clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application.
  • Oversee population PK, ER, c-QTc analyses conducted by the vendors and perform PK NCA analysis/fit-for-purpose PK/PD simulation if needed.
  • Provide expert PK/PD advice to cross-function project teams.

 

  • Advanced degree (PhD, PharmD, MSc) in Pharmacology, Pharmaceutical Sciences, or related field.
  • Minimum of 5 years of experience in clinical pharmacology in the pharmaceutical industry.
  • Strong knowledge of PK/PD principles and their application to clinical pharmacology.
  • Familiarity with PK/PD software (e.g. WinNonlin, NONMEM, Monolix, R, etc) and working knowledge of MIDD concepts.
  • Experience in oncology small molecule development is preferred.
  • Experience in regulatory submissions and interactions with regulatory agencies.
  • Experience in clinical pharmacology study design and interpretation.
  • Experience in clinical pharmacology data analysis and reporting.
  • Excellent written and verbal communication skills.
  • Ability to work independently and as part of a team.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others


Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles

Apply here

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Beckman Coulter Diagnostics

Job Title: Staff Clinical Project Manager

Location – USA Remote

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Staff Clinical Project Manager for Beckman Coulter Diagnostics is responsible for managing the In-Vitro Diagnostic clinical research for the Neurodegenerative Disease portfolio.

This position is part of the Clinical Affairs department located in Chaska, MN and will be Remote. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Clinical Affairs Team and report to the Senior Manager of Clinical Affairs responsible for In-Vitro Diagnostic Clinical Research. If you thrive in an innovative, dynamic role and want to work to build a world-class Clinical organization—read on.

In this role, you will have the opportunity to:

  • Design and lead early phase clinical research focused on neurodegenerative disease clinical evidence planning and portfolio development.
  • Develop clinical strategy, protocol design, case report form and informed consent design.
  • Manage clinical study timelines, resource demand and budget across the disease portfolio.
  • Develop internal and external partnerships to ensure stakeholder satisfaction.
  • Support good clinical practice and scientific integrity concepts.
  • Proactively identify and resolve business challenges and/or regulatory issues.

The essential requirements of the job include:

  • Bachelor’s Degree in field with 14+ years of experience or a master’s degree with 12+ years of experience or PhD/MD degree with 9+ years of experience
  • Experience designing sponsored clinical studies for in vitro diagnostic (IVD), pharmaceutical, or medical device.
  • Advanced knowledge of Good Clinical Practice and global IVD medical device
  • Experience developing regulatory strategy as it relates to clinical study design and negotiating with regulatory agencies as a subject matter expert.
  • Experience in neurodegenerative disease clinical research

It would be a plus if you also possess previous experience in:

  • Experience working with external strategic partners.
  • Experience collecting real world evidence.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

The annual salary range for this role is $150 - $200 K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.  Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

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

If you’ve ever wondered what’s within you, there’s no better time to find out.

To apply by sending updated resume to: Patina Jackson at patina.jackson@danaher.com and use external link to apply.