Clinical scientist job description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
What you will be doing:
Assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management May support a single study or multiple studies May lead a study with limited scope (e.g., Survival Follow-up) May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives
Qualifications
What you need to have:
Educational Requirements
BS/BA/MS/PhD in Life Sciences with 2+ yrs relevant career experience If no degree in Life Sciences, must have significant experience in clinical development (>5 years)
Minimum Years of Experience
Pharmaceutical experience beneficial but not required TA (Oncology) specific experience beneficial 2 years medical monitoring experience preferred Demonstrated oral and written communication skills Excel and PP experience required Ability to travel up to 15% (might include international travel) To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
Position based remote in US or Canada

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, color, 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.


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The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As QuidelOrtho continues to grow, we are seeking a Clinical Scientist I (Sample Coordinator). The Clinical Scientist, under the supervision of the Clinical Affairs Manager will be responsible for managing the inventory of clinical samples and non-clinical samples collected and purchased by the clinical affairs group. The Clinical Scientist will work in a team environment on sample acquisition, related handling, and proper management to ensure samples are available for testing purposes. The individual will drive results through a focused and disciplined approach to clinical development that is consistent with best practices in the industry. This position is located in Rochester, NY.

The Responsibilities
Receipt and reconciliation of incoming sample shipments.Management of sample inventory within the Labware database.Database tracks sample storage location, space allocation, demographic and/or medical information related to samples.Receipt and Processing requests for sample retrieval from the biorepository.Assisting project teams with the acquisition of characterized samples from vendors.Preparing samples for offsite shipping to Centers of Excellence testing sites.Aliquoting serum and plasma samples upon receipt from collection sites.Maintain EXCEL spreadsheet of patients and intended testing sites.Ordering and receiving materials necessary for sample collection kits Support clinical personnel with the assemble and shipment of collection kits to collection sites.
Coordinate the biorepository function in support of clinical trials, handling of potentially biohazardous materials including blood, body fluids and other tissues from various sources, data management of the data associated with the specimens including support of clinical trial logistics (sample fulfillment, shipments, randomization, and labeling).Performs other work duties as assigned.

The Individual
Bachelor or higher degree required in a biological science (medical technology, clinical laboratory science, microbiology, infectious diseases, immunology, biochemistry, or closely related science).3 or more years of clinical laboratory experience, R&D, or validation experience preferred. Experience with diagnostic laboratory methods and handling biohazardous materials including proficient pipetting skills.Must be willing to work with potentially biohazardous materials in an approved safe manner and to work in biohazardous environments.Knowledge of regulations and standards (CFR, GCP, ICH, ISO, etc.) affecting IVDs and Biologics required.Demonstrated ability to build and foster relationships with scientific and medical thought leaders.Must be able to work both independently and within a cross-functional team environment. Proven oral and written communication skills.Proven interpersonal, leadership and organizational skills & effective time management.Ability to work independently and within a cross-functional team environment to solve problems and to make sound decisions.Strong interpersonal and negotiating skills when dealing with colleagues, peers, and outside professional contacts.Demonstrated experience in computer skills to include Microsoft Word, Excel, and basic templates.

Key Working Relationships
Internal: Interacts with department personnel from, Clinical Affair Team Leads and Assay Product Development to align deliverables required for the conduct of clinical studies.External: Interacts with clinical investigators, consultants, sample vendors, clinical research organizations and other external service providers to coordinate clinical sample shipments for the conduct of clinical and non-clinical studies.

EOE/AA Disability/Veteran

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin's Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients' lives.

The Clinical Pharmacology Scientist I role will be responsible for the design, execution, interpretation and reporting of both nonclinical and clinical Pharmacokinetic/Pharmacodynamic (PK/PD) studies. With a growing portfolio, this individual will have the opportunity to work on small molecules, protein therapeutics and gene therapies across the development cycle (candidate selection to post marketing). This individual will work with Clinical Pharmacology leaders on projects and provide support in characterizing the Clinical Pharmacology profile with an emphasis on dose and regimen selection. Depending on experience, this individual could also serve as the Clinical Pharmacology representative on study and project teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators.
RESPONSIBILITIES

* Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development across drug modalities (eg: small molecules, oligonucleotides, gene therapies) and therapeutic indications
* Analyze, Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing
* Perform population PK and PK/PD analyses on drug candidates as they progress through clinical development
* Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel within BioMarin for the timely completion of clinical and nonclinical studies and regulatory filings
* Represent Clinical Pharmacology on multi-disciplinary study teams with a potential to represent the function on project teams
* Write protocol sections, analysis plans, reports, sections to INDs, NDAs, etc.

EXPERIENCE

Required

* 0 to 5 years of industry experience with a strong background in Pharmacokinetics and Pharmacodynamics
* Strong training in PK/PD analyses with a preference for population-based modeling and simulation
* Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin and NONMEM software
* Excellent writing and verbal communication skills
* Ability to work in a matrix environment and with different leadership styles
* Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated

Preferred

* Experience with therapies in neurological and/or cardiovascular disorders
* Post-doctoral and/or some industry experience

EDUCATION

* Ph.D. in a Pharmaceutical Science, Pharmacology or related field such as Bioengineering with an emphasis in PK/PD modeling

LEVEL GUIDELINES:

Scientist 1:

* PhD or equivalent relevant experience, plus 0-2+ years industry experience

Scientist 2 :

* PhD or equivalent relevant experience plus 2-5+ years industry experience

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.