You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• Provide strategic and operational leadership for the clinical pharmacology team including planning, budgeting, recruiting, and leading the team.

• Oversee design, delivery, and scope of integrated or stand-alone clinical pharmacology services to meet needs of current and prospective clients.  Responsible for the associated budget and proposal templates to ensure consistency of service design, delivery, and gross margin.

• Responsible for organizational design and development to cultivate knowledge and skills essential to effective service delivery including a contractor network to supplement and complement in-house capabilities and enable comprehensive service delivery. 

• Monitor industry trends and developments to ensure ongoing readiness of the clinical pharmacology organization and services to meet client needs.  Develops and implements plans and objectives to drive revenue and gross margin growth in alignment with corporate strategy, plans, and goals. 

• Ensure excellent working relationship between the clinical pharmacology group and other consulting and clinical development services functions, to preserve alignment across activities and ensure client service excellence.

• Support team members in the development and execution of client services and directly support clients through billable consulting project work, as and when needed.  Interact with FDA and other regulatory health authorities as part of drug development meetings (eg, Pre-IND, EOP2, Pre-NDA) and prepare/mentor other scientists, regulatory professionals, and sponsors for FDA meetings.  Oversee or complete data review, protocol design, regulatory submission section authoring and review (e.g., CTD sections for INDs, BLAs and NDAs), and other necessary project work.

• Monitor operational performance of clinical pharmacology organization, including individual and team utilization and service delivery effectiveness.  Manages assignment of the clinical pharmacology team members to business development activities and contracted clients and projects to drive client support based on capacity and expertise. 

• Represent Premier in the scientific community and the marketplace.  Support commercial planning and activities.  Participate as a subject matter expert in business development.  Contribute to thought leadership through content development and delivery.  Attend industry conferences and events.

• Contribute to and provide strategic input to the Consulting Leadership Team, including development of business plans and targets; adherence to operational standards; and support of the group and company culture to include culture pillars and core values through leadership actions and personal behaviors.

What We Are Searching For:

• Ph.D. in pharmacology, pharmaceutical sciences, PharmD, or a related discipline

• 10-15 years of experience in clinical pharmacology studies/programs for biological and small molecules, development of compounds and biologics in a CRO, pharma, biotechnology, or related environment. 

• Knowledge in 505(b)(2) programs and regulatory requirements for biologics, gene therapy, and/or vaccines is highly desired.

• Board certification in Clinical Pharmacology (e.g., DABPC (AP)) is highly desired.

• Demonstrated knowledge of the research process and direct research experience.

• Demonstrated scientific writing and editing skills.

• Ability to work collaboratively in a team environment, including global companies and sponsors.

• Able to read, analyze, and interpret common scientific and technical journals.

• Define problems, collect data, establish facts and draw valid conclusions.

• Effectively communicate technical concepts within a project team in both written and spoken English.

• Flexibility regarding schedule and work projects.

• Ability to travel 10-15%, including inter-office travel.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status