OVERVIEW We are currently searching for a skilled professional to join a well-known client's team as a Director, Clinical Pharmacology in the Wilmington, DE area. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
As an Associate Director or Director within the Clinical Pharmacology Group, you will have ultimate responsibility and accountability for clinical pharmacology programs.
As a member of the Clinical Pharmacology team, you will have unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, you will have the advantage of providing input into a breadth of products within and across your area of responsibility. We seek to provide a fun and rewarding career and a continuous learning experience.
RESPONSIBILITIES

• Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds
• Representing the department and providing subject matter expertise on cross-functional project teams
• Developing and maintaining collaborative working relationship with colleagues within and outside the department
• Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
• Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
• Execution of Clinical Pharmacology studies in close collaboration with Clinical Operations
• Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
• Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Participating in and collaborating with individuals from across the business in special projects

EXPERIENCE

• At least 5 years' experience working in pharmacology
• Must have experience working with healthy subjects with strong understanding of patient safety

EDUCATION

• PhD, PharmD or MD degree or similar degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline

QUALIFICATIONS

• Excellent written and oral communication skills and ability to convey complex technical information clearly
• Confidence and ability to present to and influence senior leaders
• Ability to critically analyze problems and provide creative solutions
• Confidence and discipline to work autonomously
• Genuine curiosity and drive to ask questions - looking for the 'why' of every project
• Desire to strive for continuous improvement

To be a best-fit your strengths must include:

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.