Director, Investigational Drug Section

Job Description

Job Description

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. 

The START Center for Cancer Research is seeking a  Director, Investigational Drug Section  who is responsible for overseeing all components of IDS operations at the assigned site. Additionally, the director should fulfill all existing clinical pharmacist job duties. This includes all facets of medication order verification, dispensing and documentation process for investigational drugs, conventional chemotherapy and supportive care medications provided by the IDS. The pharmacist may be involved in the provision of pharmaceutical care including assisting with patient interviews, maintenance of current medication lists, providing patient medication education, providing drug information to the healthcare team and patients. The pharmacist will practice with a high degree of autonomy, guided by IDS SOPs and quality assurance verification guidelines. This role is responsible for the daily supervision of staff assigned to medication preparation, dispensing, and operation of the IDS in accordance with all applicable rules and regulations.  The director will serve as a direct supervisor to all site-specific pharmacy team members including other pharmacists and pharmacy technicians. 

Essential Responsibilities

• Partner with Director, Nursing and study operations leader to ensure efficient, high quality
  patient care is maintained and prioritized  

• Collaborate with site leadership team, shared services leaders and integration team members to promote alignment in workflows and processes  

• Ensure adherence to all local/federal expectations for IDS space, ensure compliance with all applicable internal SOPs  

• Verify medication orders including accuracy of dosages and calculations, review of basic patient eligibility criteria, including but not limited to accurately signed / dated study consent form(s), laboratory values within treatment criteria, all appropriate tests have been completed, resolution of known toxicity from previous chemotherapy, and an absence of serious known drug interactions.   

• Oversee the preparation and dispensing of all medications from the IDS, including supervision of certified pharmacy technicians during preparation of IV admixtures and oral medication dosages, insuring compliance with all steps of the double-check verification process prior to releasing dosages from the IDS.   

• Provide pharmaceutical care including patient medication and supportive care counseling, and drug information to the healthcare team and patients.   

• Oversee drug inventories including documentation of current inventory, projection of expected usage in concert with ordering, receiving, storage and dispensation tracking of Phase I and conventional medications.   

• Assist pharmacy technicians in maintaining adequate investigational documentation, records, weekly inventory, and interactions with study personnel   

• Review new protocol(s), protocol amendments and associated forms.   

• Maintain and generate reports using the IDS drug accountability program.  

• Contribute to the effective operation of the pharmacy department. Enter accurate medication computer order entries and accurate maintenance of reported patient home medications in the EMR.   

Required Education and Experience: 

• Graduate of an ACPE accredited School of Pharmacy.  

• Current State license.   

• Previous hospital/clinic pharmacy experience.  

• Familiarity with sterile compounding requirements for chemotherapy agents, USP <797> , USP <800> , laminar airflow hood(s) / biological safety cabinet(s); telephone and copier / scanner / facsimile machine.  

• Computer skills, including use Microsoft
  Office products, including Word, Excel, Power Point and Access. 

• Familiarity with the use of electronic medical record program(s), pharmacy software programs and study IRT systems.  

• Knowledge of Good Clinical Practice (GCP) principles. 

• Sterile compounding & chemotherapy certification. 

• Intravenous sterile product training.   

• Prior experience in clinical trials and management of investigational drugs. 

Preferred Education and Experience:  

• Specialty residency in oncology and/or current BPS Board Certified Oncology Pharmacist (BCOP).   

Physical & Travel Requirements: 

• 80% of time spent standing and/or walking.   

• Ability to lift up to a 25-pound weight load.  

• Some lifting and bending, pushing and/or pulling loads.  

• Intermittent travel, less than quarterly, to support new site activation    

Best-in-Class Benefits and Perks

We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and vision insurance provided
• Robust retirement planning: 401(k) plan available with employer matching
• Financial security: Life and disability insurance for added protection
• Flexible financial options: Health savings and flexible spending accounts offered
• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
• Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.

More about The START Center for Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.

Learn more at STARTresearch.com.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.