Executive Director, Study Start Up

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Summary:

The Executive Director, Site Start Up position is responsible for all clinical site start-up activities and provides leadership, line management, and serves as subject matter expert for the clinical operations organization. 

Essential Functions:

• Drive implementation, continuous assessment and improvement for site-start-up activities, including (but not limited to): site feasibility, site essential document collection, review & filing, site contract development & execution, site activation support.
• Work with the rest of the Executive team in establishing corporate objectives and delivering within the assigned framework.
• Supports Business Development Department efforts in identifying new opportunities.
• Assist with the development and completion of RFI and RFPs responses for clinical operations delivery.
• Accountable for design and implementation of strategic and operational resourcing plans for the Clinical Operations organization including ensuring open headcount positions are identified and filled expeditiously with qualified individuals, and long-range planning to meet scalability, productivity goals and succession planning.
• Develops and executes staffing plans to ensure adequate and appropriate clinical operations delivery.
• Recruits, motivates, and manages all start-up and clinical operations staff to ensure professional development and training of a high performing team with an aim towards operational excellence, and fostering a collaborative, highly integrated and collaborative culture.
• Fosters and contributes to a culture of collaboration and learning across the organization that aligns with the Company’s values.
• Partners with other department heads to maintain strong, positive collaborations and ensure effective priority setting, budgeting, and resource deployment.
• Implements a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies, and industry best practices.
• Establishes quality processes within Clinical Operations that focus on data integrity and patient safety while identifying possible improvements and initiating and implementing the same.
• Accountable for and contributes to the design of operational excellence activities including program and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials.
• Supports responses to audits (site, internal file and process, and regulatory agencies).
• Serves as the functional representative during inspection readiness activities and during on-site regulatory audits/inspections.
• Supports Quality Incident reporting activities and resolution of CAPAs related to the conduct of clinical trials.
• Supports the development and optimization of processes for Clinical Operations (SOPs). Proactively assesses the need for new/updated processes and implements process improvement initiatives.
• Other duties as assigned.

Necessary Skills and Abilities:

• Supports the development and optimization of processes for Clinical Operations (SOPs). Proactively assesses the need for new/updated processes and implements process improvement initiatives.
• Thorough understanding of clinical development cross functional lifecycle.
• Work with the rest of the Executive team in establishing corporate objectives and delivering within the assigned framework.
• Supports Business Development Department efforts in identifying new opportunities.
• Assist with the development and completion of RFI and RFPs responses for clinical operations delivery.
• Accountable for design and implementation of strategic and operational resourcing plans for the Clinical Operations organization including ensuring open headcount positions are identified and filled expeditiously with qualified individuals, and long-range planning to meet scalability, productivity goals and succession planning.
• Develops and executes staffing plans to ensure adequate and appropriate clinical operations delivery.
• Recruits, motivates, and manages all clinical operations staff to ensure professional development and training of a high performing team with an aim towards operational excellence, and fostering a collaborative, highly integrated and collaborative culture.
• Fosters and contributes to a culture of collaboration and learning across the organization that aligns with the Company’s values.
• Partners with other department heads to maintain strong, positive collaborations and ensure effective priority setting, budgeting, and resource deployment.
• Implements a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies, and industry best practices.
• Establishes quality processes within Clinical Operations that focus on data integrity and patient safety while identifying possible improvements and initiating and implementing the same.
• Accountable for and contributes to the design of operational excellence activities including program and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials.
• Supports responses to audits (site, internal file and process, and regulatory agencies).
• Serves as the functional representative during inspection readiness activities and during on-site regulatory audits/inspections.
• Supports Quality Incident reporting activities and resolution of CAPAs related to the conduct of clinical trials

Educational Requirements:

• Bachelor’s degree or advanced degree (e.g., Master, PharmD, PhD) preferred. Candidates with equivalent combination of education, training, and experience will be considered.

Experience Requirements:

• Deep understanding of global study start-up activities in a clinical trial setting
• Awareness of regulatory requirements / regulations in countries ProPharma is currently or plans to be active in
• Line management experience with a team of ≥5, global line management preferred 
• Ten (10) years of clinical development experience in the pharmaceutical industry or an equivalent combination of experience with advanced degree(s).
• A minimum of five (5) years’ experience in a leadership capacity including managing permanent and contract direct reports.
• Experience working at a Sponsor company and a CRO is preferable.

#LI-JH1