The Pharmacy Director in the area of Investigational Drugs will oversee clinical, operational, financial, regulatory and human resources management of all research and investigational drug services. The individual serves as a member of the Pharmacy Leadership Team. The Director works directly with research and medical staff leadership, nursing and pharmacy to promote practice that achieves quality outcomes and medication safety that contribute to the overall success of DM Clinical Research.
DUTIES & RESPONSIBILITIES
- Ensure facilities, security, and accountability according to DMCR, FDA, GCP guidelines, and other regulatory requirements. Ensures that all equipment and facility requirements are compliant with all investigational drug services requirements
- Acts as the liaison with internal affiliated departments and external stakeholders to ensure program integrity
- Attract, retain, and develop a quality Clinical Pharmacy Staff across the enterprise. Ensures clinical research pharmacy staff training and competency
- Lead and manage pharmacy staff, including hiring, training, and performance evaluations, to ensure a competent and motivated team
- Serves as the primary leader responsible for program oversight and all pharmacy research related matters
- Serves as the primary compliance expert on investigational drug program details, policies, and procedures, and ensures compliance with all regulatory standards and proper Investigational Drug Product Accountability and Documentation
- Collaborate with medical staff to promote medication safety
- Stay updated with current trends, advancements, and regulatory changes in pharmacy practice to ensure compliance and provide expert advice to healthcare providers
- Foster effective communication and collaboration with other departments and healthcare professionals to optimize patient outcomes
- Work with DMCR Leadership, investigators, pharmacists, and other department managers and key committees to promote safe and effective use of investigational drugs
- Provides oversight over Investigational Drug Product Dose Preparation and Dispensing. Provides oversight over monitoring visits and/or audits of the clinical research pharmacy and supports such activities at the enterprise level
- Prepare and present reports to the executive leadership team, providing analysis and recommendations to improve pharmacy services and meet organizational goals
- Actively engages with senior leadership and participates in decision-making processes related to the expansion of the research program and/or changes of program
- Represent the pharmacy enterprise in all research related committees
- Follows established department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality
KNOWLEDGE & EXPERIENCE
Education:
- B.S. in Pharmacy, PharmD, required
Experience:
- Registered Pharmacist Pharmacy Experience
- 10 years of experience in pharmacy
- 6 years of experience leading in a pharmacy leadership capacity
- 5+ years in Clinical Research required
- 3+ years in Investigational Product Management
- Minimum 3 years in managerial or supervisory role
Credentials:
- Appropriate state licensure for assigned region
Knowledge and Skills:
- Strong leadership and managerial skills to lead and motivate a team of pharmacy professionals
- Excellent communication and interpersonal skills to effectively collaborate with various stakeholders, including healthcare providers, patients, and administrative staff
- In-depth knowledge and understanding of pharmaceutical principles, drug therapy, and medication management practices
- Strong understanding of financial management and budgeting
- Proficiency in pharmacy information systems and technology to optimize pharmacy operations and enhance patient safety
- Analytical and problem-solving skills to identify and resolve complex pharmacy-related issues
- Ability to prioritize and manage multiple tasks in a fast-paced environment while maintaining attention to detail and accuracy
- Excellent organizational and time management skills to meet deadlines and manage competing priorities
- Knowledge of relevant regulations and accreditation standards (e.g., Joint Commission, CMS) pertaining to pharmacy practice