Clinical Pharmacology Project Lead

2 days ago

Remote, Oregon, United States Analytix Solutions Full time $200,000 - $262,000 per year

The Director, Clinical Pharmacology actively contributes to multi-disciplinary teams by providing innovative and progressive thinking on projects and where appropriate, offers guidance to other team members.

In addition to possessing the scientific expertise, the incumbent must be capable of analyzing and interpreting study data and effectively communicating findings to a broad audience. The Director, Clinical Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to provide sound input on Clinical Pharmacology activities to a variety of project teams.

Essential Functions

Directs and Implements clinical pharmacology plans and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads the development of Clinical Protocols to meet CDP objectives.

Serves as Study Director/Clinical Pharmacology Lead and drives the execution of the study from protocol concept to final report including interpretation of clinical data.

Serves as Medical Monitor (where applicable) to review and monitor study data.

Implements strategies to identify, monitor and resolve clinical program/trial issues.

Interprets study data and develops integrated summaries of Clinical Pharmacology data as it relates to safety and efficacy.

Contributes to Clinical Pharmacology expertise and content to regulatory documents (e.g. briefing books, INDs, NDAs etc.) and represent Clinical Pharmacology in discussions with Health Authorities.

Reviews 3rd party work products and deliverables to approve payment of invoices and resolve discrepancies.

Requirements

A PhD, MD or PharmD degree with at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead.

A thorough understanding of global regulatory requirements on the Clinical Pharmacology and Translational Medicine aspects of drug development.

A thorough understanding of standard Clinical Pharmacology computational programs.

Experience in oncology, pediatric development and translational medicine is preferred but not required.

Strong inter-personal skills are required since the job requires substantial interaction within the assigned Business Group as well with other Pre-clinical, Modeling, and Translational Science Groups.

Complies with all applicable laws/regulations of each country Clinet does business in.

Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients or physicians.

Minimal travel required: less than 10%

Job Type: Full-time

Pay: $200, $262,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Education:

  • Doctorate (Required)

Experience:

  • Oncology: 5 years (Preferred)
  • Clinical Development Plan: 5 years (Preferred)

Work Location: Remote

  • Senior Director and Section Head of Clinical Pharmacology

    4 days ago

    Remote, Oregon, United States Biogen Full time $242,000 - $333,000

    About This Role The Senior Director and Section Head of Clinical Pharmacology & Pharmacometrics leads a team of clinical pharmacologists providing scientific leadership and execution of clinical development plans from Phase 1-Phase 4 programs.  This includes prediction and characterization of the pharmacokinetics, pharmacodynamics, efficacy of drug...

  • Associate Scientific Director, Clinical Pharmacology

    6 days ago

    Remote, Oregon, United States Biogen Full time

    About This RoleAs the Associate Scientific Director, Clinical Pharmacology you will serve as the clinical pharmacology lead on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and...

  • Technical Project Manager

    6 days ago

    Remote, Oregon, United States Clinical Ink Full time $120,000 - $180,000 per year

    Company InformationClinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data...

  • Manager, Clinical Monitoring

    5 days ago

    Remote, Oregon, United States Catalyst Clinical Research Full time $95,000 - $145,000 per year

    As a Manager, Clinical Monitoring you are a key member of the Development Operations, Clinical Monitoring Team responsible for the line management of Clinical Research Associates. This includes professional development, mentoring, coaching, performance management including assessment visits, and resource management. Management duties will include oversight...

  • Lead Clinical Scientist, Transplant

    4 days ago

    Remote, Oregon, United States Biogen Full time $180,000 - $248,000

    Biogen's West Coast Hub is seeking an accomplished and highly motivated Lead Clinical Scientist to provide scientific, strategic, and operational leadership for our organ transplantation clinical development program. This role will help lead the design, execution, and advancement of late-stage clinical trials in antibody-mediated rejection and other...

  • Regional Project Lead

    1 day ago

    Remote, Oregon, United States PSI CRO Full time $80,000 - $120,000 per year

    Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals.  We work on the front-line of medical science, changing lives, and bringing new medicines to...

  • Clinical Project Manager

    4 days ago

    Remote, Oregon, United States Scout Full time $80,000 - $120,000 per year

    Established in 1996 and rebranded to Scout in 2024, we built our foundation on planning meetings for numerous organizations within the life sciences sector (Scout Meetings). In response to emerging industry needs, we expanded our services to include Scout Clinical, one of the top providers of clinical trial patient travel and reimbursements, and Scout...

  • Clinical Project Manager

    6 days ago

    Remote, Oregon, United States INSIGHTEC Full time $120,000 - $180,000 per year

    Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.Our dedication to making a...

  • Director of Clinical Operations

    2 days ago

    Remote, Oregon, United States UST-Clinical Full time $185,000 - $225,000 per year

    Director of Clinical Operations in biotech will be responsible for the strategic planning, execution, and management of clinical trials to ensure they meet company goals, budgets, and quality standards. Key responsibilities include overseeing trial sites, managing vendor relationships (like CROs), ensuring regulatory compliance.Key responsibilitiesClinical...

  • Technical Project Lead

    6 days ago

    Remote, Oregon, United States Bamboo Health Full time

    Bamboo Health is the leader in Real-Time Care Intelligence solutions aimed at improving lives for everyone experiencing physical and behavioral health challenges. We are driven by our mission to empower clients to deliver seamless, high-quality and cost-effective care during pivotal moments to improve health outcomes. From coast to coast, Bamboo Health...