Head, Clinical Operations
ROLE AND RESPONSIBILITIES
The Head of Clinical Operations is accountable for strategic planning, oversight, execution of clinical programs. You must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. You will have clinical interactions with multidisciplinary scientists across the company including the CSO, COO and Chief Clinical Development.
Essential Duties & Responsibilities:
- Oversight, management and guidance of phase I – III clinical programs to ensure highest quality, timeline and milestones, and budget goals are met
- Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas within.
- Interact and collaborate with other management team members as appropriate.
- May present Clinical Operation updates to the executive team and to the Board
- Responsible for the strategic resource management of in-source/out-source study requirements
- Evaluate and select service providers (often in collaboration with the company’s COO) and manage these resources effectively
- Perform other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
Have the ability to evaluate and resolve complex problems
Excellent verbal and written communication skills
Must have a thorough knowledge of clinical research concepts, practices, and FDA/EMA regulations and ICH Guidelines regarding drug development phases, clinical research and medical affairs trials, clinical study design, and data management methods.
Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws
Experience with global drug development and BLA/NDA/MAA filing is preferred
Experience in developing protocols, SOPs, Clinical Study Reports, INDs and IMPDs, BLA, MAA and NDAs, as well as other clinical, regulatory, and safety documents
Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
Daily demonstrates a positive, ‘can do’ and service-oriented attitude; detail-oriented with a commitment to accuracy.
Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks and to meet preset and to meet deadlines.
Ability to multi-task and shift priorities quickly while working under tight deadlines.
Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Able to travel as required by business needs
Communication & Interpersonal Skills
Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees at the company.
Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
Dynamic and innovative skill with a well-developed sense of teamwork.
The company is a fast-moving small-medium company, with a sense of urgency around what we do, and a successful colleague can manage ambiguity and uncertainty successfully, and can develop and execute project plans within a busy environment
Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferable
Eight or more years of clinical trial experience in a similar role at a pharmaceutical, biotechnology or CRO company
Ability to effectively manage multiple clinical projects concurrently
Travel, Physical Demands And Work Environment
Regularly required to operate standard office equipment
Ability to work on a computer for extended periods of time
Regularly required to sit for long periods of time, and occasionally stand and walk
Regularly required to use hands to operate computer and other office equipment
Close vision required for computer usage
Occasionally required to stoop, kneel, climb and lift up to 20 pounds