Associate Clinical Pharmacology Director

Benefits

Qualifications

• •Bachelor's Degree and Ten Years' Experience
• •Masters' Degree and Eight Years' Experience
• •PhD/PharmD and Five Years' Experience
• •Has significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology
• •Demonstrate ability to effectively apply business acumen to strategic scientific projects
• •When needed, ability to travel
• •3 more items(s)

Responsibilities

• •As a member of a drug development team, routinely provides input into product development strategies and/or research or clinical development plans for assigned products / projects
• •Authors the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area
• •Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, which includes responsibilities for leading the respective cross-functional study team
• •With input from others, designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans
• •Leads study protocol review discussions concerning scientific and procedural aspects of pharmacology study design
• •Works with cross-functional partners and study sites to implement and monitor clinical pharmacology studies
• •Addresses clinical issues arising from clinical pharmacology studies
• •Directs the activities and resources for both internal and external study partners
• •Manages study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies
• •Conducts PK-PD and related analyses and provides clinical pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific presentations or literature
• •Analyzes, interprets and authors documents for clinical and regulatory submissions
• •Presents project updates and other key milestone information to cross-functional partners and stakeholders
• •May support business development / due diligence activities as a clinical pharmacology expert
• •Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies
• •Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thinking
• •Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
• •Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams
• •Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential
• •They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose
• •Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account
• •They provide the support needed to remove barriers and connect their team to the broader ecosystem
• •18 more items(s)