Clinical Jobs

Responsible for devising and directing pharmacokinetic (PK)/ pharmacodynamic (PD) aspects of Early Development and Clinical Pharmacology strategies and plans for all IND-track and development compounds. Manages all aspects including scientific development and design, implementation, analysis, interpretation and reporting of PK/PD results in early and late stage clinical programs. Represents Early Development and Clinical Pharmacology at strategy, development and therapy area level teams and including regulatory meetings. Responsible for preparing and compiling clinical pharmacology aspects of global regulatory submission and documents.

Job Responsibilities

*Lead preparation and execution of Early Development and Clinical Pharmacology plans and strategy to meet corporate, scientific and regulatory needs.

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The Clinical Pharmacy group at Wyeth BioPharma is responsible for the planning, coordination and supply of drug products for global clinical studies. Working with a wide cross-section of functions within Wyeth and external partners, the Clinical Pharmacy group plays a critical role in ensuring the timely supply of study materials to the clinical sites. Clinical Pharmacy works with clinical study teams from first-in-person studies through regulatory approval and post-marketing studies to assess the drug supply requirements for potential worldwide clinical trials. Additionally, Clinical Pharmacy initiates bulk and packaging documents necessary for the preparation of Clinical Trial Material (CTM) and works cross-functionally to ensure the timely delivery of clinical supplies.

Act as a Clinical Pharmacy representative to BioPharma, Chemical and Pharmaceutical Development (CPD), Clinical Research and Development, Regulatory Affairs and others as needed.

Working knowledge of GCPs and clinical trial processes
- Ability to manage multiple priorities across several protocols and therapeutic areas simultaneously
- Identify and recruit investigators, including sites new to GSK
- Conduct site initiation, monitoring and close-out visit activities
- Track study progress and submit subject data to GSK within specified timelines for assigned sites
- Actively contribute to the development of the U.S. Monitoring (USM) organization characterized by process standardization, best practice sharing and continuous improvement
- Work within a matrix environment, cultivating strong working relationships by partnering in a collaborative manner with all internal and external customers to achieve study goals
- Proactively contribute to the resolution of complex monitoring and regulatory issues through discussions with the appropriate internal departments (monitoring, compliance, study staff, etc.)

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career within Merck.

Provides analytical support for characterization of API’s, in-process blend samples and finished drug products in support of the Pharmaceutical Development Center (PDC). Works closely with PDC team members in the design of experiments. Writes comprehensive technical reports describing the results of experiments. Applies creative ability and knowledge of analytical methods and technologies to solve the most complex analytical problems. Provides technical guidance to the PDC analytical team for a wide variety of characterization technologies.

Job Responsibilities

Provide clinical veterinary medical care for a variety a laboratory animal species in compliance with federal regulations, industry guidelines, and corporate policies, practices, and procedures (PPPs). Assist with operating and maintaining the animal facility in compliance with federal regulations, industry standards, and corporate PPPs.

Job Responsibilities

*Provides clinical veterinary medical and research support in accordance with current veterinary medical standards including disease surveillance, prevention, control, diagnosis and treatment. Maintains relevant animal (including medical, diagnostic and surgical) records in compliance with federal and state regulations, industry guidelines, and corporate policies.

*Supervises veterinary technicians and technologists. Develops group and individual objectives, guides the creation of employee development plans and employee development, writes performance appraisals and conducts performance reviews.

Act as change agent for innovative, simulation guided, clinical drug development planning.
•Identify potential opportunities within the R&D portfolio for implementation of Adaptive Trials.
•Provide Learn and Confirm teams with comprehensive review of innovative trial design options, and guidance on selection of most appropriate.
•Work in concert with the Learn & Confirm team leaders and Adaptive Trials Group from conception to final delivery to ensure optimal design and execution of adaptive trials.
•Work with other members of the Adaptive Trials group to distill experiences and continuously optimize processes within the group to maximize the impact of Adaptive Trial approaches at all levels of the organization.
•Serve as a liaison between Adaptive Trials and R&D to create informed advocacy between discovery, translational medicine, early and late development
•Present and educate internal and external audiences on value added of work conducted.

At Merck, we believe in putting patients first in all we do. This commitment, along with our focus on developing novel medicines and vaccines that address unmet patient needs, distinguished us as one of the world's leading research-driven pharmaceutical companies. And it leads us to do amazing things, such as:
Discover and develop medicines and vaccines that provide true advances in patient care
Use our proven research ability to tackle diseases like cancer, Alzheimer's, diabetes and obesity
Help patients who need financial assistance to get the medicines they need
Bring hope to people around the world affected by health crises like HIV/AIDS and river blindness
Make free, unbiased general health information available to everyone
If you, like us, strive for excellence in all you do, consider joining our team of talented and dedicated individuals from diverse backgrounds who are united in bringing Merck's finest achievements to people around the world.

At Merck, we believe in putting patients first in all we do. This commitment, along with our focus on developing novel medicines and vaccines that address unmet patient needs, distinguished us as one of the world's leading research-driven pharmaceutical companies. And it leads us to do amazing things, such as:
Discover and develop medicines and vaccines that provide true advances in patient care
Use our proven research ability to tackle diseases like cancer, Alzheimer's, diabetes and obesity
Help patients who need financial assistance to get the medicines they need
Bring hope to people around the world affected by health crises like HIV/AIDS and river blindness
Make free, unbiased general health information available to everyone

If you, like us, strive for excellence in all you do, consider joining our team of talented and dedicated individuals from diverse backgrounds who are united in bringing Merck's finest achievements to people around the world.

At Merck, we believe in putting patients first in all we do. This commitment, along with our focus on developing novel medicines and vaccines that address unmet patient needs, distinguished us as one of the world's leading research-driven pharmaceutical companies. This approach to drug development leads us to do amazing things, such as:

· Discover and develop medicines and vaccines that provide true advances in patient care
· Use our proven research ability to tackle diseases like cancer, Alzheimer's disease, diabetes and obesity
· Help patients who need financial assistance to get the medicines they need
· Bring hope to people around the world affected by health crises like HIV/AIDS and river blindness
· Make free, unbiased general health information freely available to everyone