- Pfizer (Collegeville, PA)
- …way in healthcare and make a lasting impact on society.** **What You Will Achieve** As a Clinical Study Team Lead (CSTL), you will be an integral member ... team delivery of multiple complex global studies and/or programs. Your clinical development expertise...operations + Accountable for issue escalation and resolution + Lead study team chartering and… more
- Pfizer (Collegeville, PA)
- …etc.), and lead translation of pre- clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof ... **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU...of clinical research plans into efficiently delivered studies . Creative in the conception of novel study… more
- Pfizer (Collegeville, PA)
- … Lead (and members of the development team ) to establish, lead , coordinate, and execute the early oncology clinical development plan(s) for one ... signals of efficacy (ESOE) and proof of concept (POC) studies . + *The OES Clinical Scientist (Senior...protocol and may participate as an individual contributor on clinical study teams and clinical … more
- Merck (Upper Gwynedd, PA)
- …planning and execution of one or more clinical trials. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical ... team . Job Responsibilities + Responsible for specific clinical /scientific activities on a single study or...for specific clinical /scientific activities on a single study or across multiple studies (eg, medical… more
- Pfizer (Collegeville, PA)
- …excellence in support of strategic imperatives and in collaboration with the cross functional study team (s) + Ensure work carried out by or on behalf ... consistency in asset/submission data. **KEY RESPONSIBILITIES** + Serve as Clinical Data Scientist and Trial Lead for...clinical trials and ability to assess and determine study requirement from protocol review + Strong Project and… more
- Pfizer (Collegeville, PA)
- …functional lines at the core study team . The SCL provides study teams with innovative solutions to clinical drug supply production, packaging, labeling ... execution. The SCL is the matrix team lead of the MedSci GCS Clinical Supplies...of the clinical development program and project team objectives. Participate as a core study … more
- Pfizer (Collegeville, PA)
- …the appropriate roles in Clinical Development & Operations, the AQL will work with Clinical Study Team Quality Leads within their assets to ensure asset ... maintaining 'quality' line-of-sight for assets/protocols within the Pfizer Oncology clinical portfolio. + With this focus, the Asset Quality...in their tumor type(s). + Provide Study Team Inspection Readiness (IR) guidance and support; lead… more
- J&J Family of Companies (Spring House, PA)
- …in accordance with internal processes, with some mentorship from functional management and clinical team , as needed. + If a lead writer for a program: Be the ... clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study...contact and champion for medical writing activities for the clinical team . Responsible for planning, setting strategy,… more
- Merck (North Wales, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... clinical documents including development plans, protocols, trial related documents, clinical study reports and background documents. + Interfaces with… more
- Merck (West Point, PA)
- …or West Point, PA) is also based on the location of the host team . ** Clinical Quality Assurance (CQA) Co-op Opportunity:** Our Research and Development ... Division's Clinical Quality Assurance (CQA) team serves as...serves as an essential independent function with accountability to lead and support audits focused on a risk-based approach… more
- Merck (North Wales, PA)
- …if we are the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer interns. GCTO ... diverse development portfolio. It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company… more
- J&J Family of Companies (Horsham, PA)
- …, investigator-initiated and/or collaborative studies in the Dermatology TA. Contribute/ lead study design, protocol development, clinical study ... * Dermatology or immunology therapeutic area expertise is highly preferred * Experience with clinical study , registry, or real-word evidence study and prior… more
- J&J Family of Companies (Horsham, PA)
- …, investigator-initiated and/or collaborative studies in the Gastroenterology TA. Contribute/ lead study design, protocol development, clinical study ... we all belong. The Medical Affairs Therapeutic Area (TA) team is responsible for developing, coordinating and executing the...therapeutic area expertise is strongly preferred. * Experience with clinical study , registry, or real-word evidence … more
- Pfizer (Collegeville, PA)
- …expected to develop effective collaborations with relevant stakeholders (including Study Statisticians, Clinical , Development Operations, PharmSci, Regulatory ... discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and...the world. **POSITION SUMMARY** As part of the Biostatistics team , you are recognized as a subject matter expert… more
- J&J Family of Companies (Spring House, PA)
- …labeling negotiation strategies. + Provides input into strategy with respect to clinical study design. + Negotiates and manages regional post-approval ... Associate Director, North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative...+ Provides regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development… more
- J&J Family of Companies (Horsham, PA)
- …Medical Affairs, Scientific and Clinical Affairs, and R&D. + You will lead the statistical programming of epidemiologic studies using real world data. + ... all programming efforts, including statistical programming and analysis of real-world data studies to support the generation of clinical evidence for post-market… more
- ThermoFisher Scientific (Allentown, PA)
- …+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed ... clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies . This position requires overnight travel either regionally… more
- Merck (North Wales, PA)
- …a development project as needed + Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program ... for related drug/vaccine projects in Late Development Statistics. + Lead the interaction with Clinical , Regulatory, Statistical...the strategic planning and execution for product development + Lead a team of statistical and/or programing… more
- Merck (North Wales, PA)
- …for the strategic planning and execution for product development + Is involved in clinical development planning to ensure that study designs are consistent with ... statistical methodology. + Analyzes data and interprets results from clinical trials to meet objectives of the study...oral and written reports to effectively communicate results of clinical trials to the project team , company… more
- Merck (West Point, PA)
- …and late clinical development teams + Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities ... planning + Demonstrated ability to participate in and to lead an interdisciplinary team , and to oversee...packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors,… more