Associate Principal Scientist, Clinical Operations - Immunology jobs in United States
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Merck · 15 hours ago

Associate Principal Scientist, Clinical Operations - Immunology

Merck is a leading pharmaceutical company focused on improving health. They are seeking an Associate Principal Scientist to drive scientific planning, strategy, and execution of clinical studies in immunology, collaborating with cross-functional teams to ensure successful trial execution.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
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Responsibilities

Responsible for the clinical/scientific execution of clinical protocol(s)
Serves as the lead clinical scientist on the clinical trial team
Collaborates with the Medical Writer on clinical/scientific and regulatory documents
Partners with Study Manager on study deliverables
Participates in the set up and design during study start up (e.g., database set up)
Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director
Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities
May include management of direct reports including assignment of resources, professional development, and performance management
May serve as a subject matter expert and/or participate on process improvement teams

Qualification

Clinical ResearchClinical ImmunologyClinical TrialsClinical Practice (GCP)Data AnalysisClinical Data ManagementClinical Study DesignAnalytical Problem SolvingMedical WritingPeople ManagementPrioritizationProject ManagementConflict ResolutionAdaptability

Required

Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
Degree in life sciences, preferred
Demonstrated ability to drive and manage scientific activities on clinical protocols
Apply strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
Manage multiple competing priorities with good planning, time management and prioritization skills
Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions
Interact with key stakeholders across department, division, and company
Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
Demonstrated ability to effectively delegate and assign activities to meet the business needs
Problem solving, prioritization, conflict resolution, and critical thinking skills
Build team capabilities through proactive coaching
Advanced communication, technical writing, and presentation skills

Preferred

Experience in conducting global clinical trials, including trial initiation through database lock
Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders
Experience in developing protocols and study related documents for Immunology related clinical trials
Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in Immunology related clinical trials
Experience in performing medical monitoring in Immunology related clinical trials

Benefits

Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days

Company

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase