Senior Clinical Scientist jobs in United States
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Alnylam Pharmaceuticals · 6 days ago

Senior Clinical Scientist

Alnylam Pharmaceuticals is seeking an imaginative clinical scientist drug developer for the role of Senior Clinical Scientist. The successful candidate will work closely with clinical development teams to serve as a clinical research expert and support the scientific integrity and quality of assigned clinical trials.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Work with the Therapeutic Area Head as well as Medical Director(s), to create key strategic documents, including the clinical development plan, protocol concept and full protocol for one or more products in early-stage development, while also contributing to product(s) in later stages of development, including NDA filings
Contribute to the key documents describing products in development, such as the Investigators’ Brochure and safety updates
Contribute to correspondence with the health authorities approached by the assigned programs, such as the briefing book, IND, NDA, as well as responses to health authority questions
Develop a working knowledge of the operational characteristics of the clinical endpoints relevant to the assigned clinical trial indication, the study population represented by various inclusion/exclusion criteria or diagnoses, and their use in previous clinical trials, to enable informed and innovative clinical trial design
Develop a working knowledge of the clinical scales and patient reported outcome tools associated with the assigned clinical trial indication to facilitate their qualification and justification for regulatory correspondence and study start up activities
Develop a working knowledge of the biomarkers and other measured endpoints associated with the assigned clinical programs, their assay characteristics, sample handling requirements, and qualification needs, if any
Monitor regulatory policies and guidance to ensure scientific quality/innovation of clinical study design, execution, reporting and publication
Ensure that all studies observe the highest standards of ethical and safe conduct, and ensure compliance with GCP; monitor study progress and perform medical data review for endpoint and safety management to ensure integrity of study data
Develop effective working relationships with investigators in assigned programs developing study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring Committees throughout the life cycle of a program
Analyze and interpret study data from an individual study; translate study level clinical data across the program of studies for a particular drug
Facilitate the awareness of the real-time availability of clinical trial data (including safety, efficacy, pharmacokinetic and biomarker data), to provide consolidated information for dose escalation meetings, data safety monitoring boards, and interim analyses
Assist Clinical Operations in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties

Qualification

Clinical trial designDrug development expertiseRegulatory correspondencePharmacologic actionClinical Practice (GCP)Scientific abilityAnalytic abilityMultifunctional teamworkMultitaskingStrategic thinking

Required

Minimum of a college degree in life sciences or nursing degree
Minimum of 5 years of experience in clinical research or equivalent
The skills required for success in the job include scientific and analytic ability
ability to think strategically and tactically
an interest in applied clinical research
ability to work effectively in multifunctional and multinational teams
ability to multitask and prioritize

Preferred

advanced degree preferred (i.e. MD, PhD, PharmD or MS)
Clinical trial/drug development Phase 1-3 expertise highly desirable

Benefits

Medical, dental, and vision coverage
Life and disability insurance
Lifestyle reimbursement program
Flexible spending and health savings accounts
401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave

Company

Alnylam Pharmaceuticals

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Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.

H1B Sponsorship

Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)

Funding

Current Stage
Public Company
Total Funding
$4.55B
Key Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO

Leadership Team

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Yvonne Greenstreet
Chief Executive Officer
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Jeff Poulton
Chief Financial Officer
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Company data provided by crunchbase