Our Pharmaceutical client seeks a Senior Manager Early Clinical Development Group Lead who will contribute to delivering the successful conduct of assigned studies in US and to strengthen study management function by adding value to early clinical development. This position reports to the Sr. Director.

Preparation and Start-up activities before Country Study Manager (CSM) onboarding

• Review protocol synopsis/study design, master ICF and CDPs from US operation point of view
• Support selection of CRO/service provider
• Contribute to country selection from operational and/or regulatory point of view in the US
• Support feasibility survey in the US in collaboration with Study Team (ST)/CRO
• Support early outreach to PAGs if applicable
• Establish a recruitment plan in the US in alignment with the recruitment plan of the study
• Support HA and TAE consultation & Interaction
• Oversight and management of assigned Clinical personnel in the US where applicable.

CSM Oversight and support

• Oversee whether CSM activities are consistent with the goal of the project/study
• Support CSM to establish a recruitment plan and to boost enrollment in case of delay
• Oversee CSM to maintain inspection readiness consistent with GCP/SOP and local regulations
• Contribute to operational issue resolution in collaboration with CSM
• Provide guidance on SOP and Process, where needed
• Support communication between CSM and HQ (CSK) and resolve the issues/problems by communicating with CSM, Study Leader (SL), and/or line manager of SL
• Escalate regional matters to head of Early Clinical Development in a timely manner
• Support handover of CSM during studies
• Understand high-level summary of data in ongoing clinical trials to support of discussions with PI/site/CRO.

Value Adding Activities

• Identify and build relationships with TAE and next-generation leaders in the US
• Maintain connection with high-performing/unique specialty clinical sites and site networks in the US
• Contribute to collaboration with PAG in the US
• Accumulate and utilize Lesson & Learnt in the US
• Contribute to process improvement including collaboration
• Contribute to adaptation of new clinical trial initiatives in the US
• Ensure to follow the latest regional regulations, ensure processes & SOPs are up to date.
• Support identify/access to cutting-edge technology in the US
• Contribute to the assessment of CRO performance in the region and attend governance meetings, where needed.

Supervisory

• This job may have direct supervisory responsibilities next to the above listed SMGL responsibilities.

Travel Requirement

• 1-3 times per year, internationally to Japan (Company HQ), Europe (Company Affiliates), or other locations (related to position) as well as domestically (typically up to 30%).
• Possible travel requirements for training or conference(s), usually domestic but potentially international.

REQUIREMENTS

• MD or MS in a pharmaceutical-relevant field
• 7+ years experience managing (global) oncology, clinical trials as Study Leader. Experience leading and managing multi-regional studies.
• Experience working within a global environment, preferably including Japan
• Experience in process development and SOP review
• Demonstrable general knowledge of clinical trial conduct in assigned indications or ability to become proficient in a short period.
• Cultural awareness. The skills to address conflicts with both local and CSK colleagues; contexts rely on a nuanced comprehension not just of cultural variations like high/low context and hierarchical/flat communication but also on recognizing the numerous distinctions between the local environment and Japan. These distinctions encompass factors such as the medical and social environment, lifestyle, and more.
• Experience in personnel management
• Ability to identify risks from cross-study point of view
• Advance knowledge of ICH-GCP and local regulations
• Proficient in Microsoft Suite, including PowerPoint
• Working knowledge of virtual meeting software and tools
• Advanced project management skills
• Communication skills
• Proactive risk management skill
• Demonstrate sound judgment and analytical problem-solving. Understands issues both in and outside area of expertise. Demonstrates technical/professional competency. Establishes effective plans, allocates resources efficiently, and manages time effectively.
• Build good working relationships throughout all levels of the organization. Exhibits tact and accepts constructive feedback. Demonstrates effective written and oral communication; facilitates honest and open communications, listens well; displays appropriate conflict resolution (keeps emotions under control in difficult situations).
• Accepts assignments willingly; keeps commitments and follows through and responds to requests in a timely manner. Demonstrates commitment to the organization and takes initiative to generate new ideas by thinking beyond existing processes. Seeks increased responsibilities.
• Teamwork evidenced by a cooperative effort to achieve common goals; volunteers for added responsibilities; completes team assignments on time. Exhibits objectivity and openness to other’s views. Puts success of team above own interests. Contributes to building a positive team spirit.
• Leadership evidenced by positively influencing others to act. Thinks strategically by considering a broad range of factors when making decisions and solving problems. Identifies high payoff strategies. Reacts well under pressure. Inspires respect and trust and manages for organizational success (financially and operationally). Demonstrates and promotes Leadership Philosophy. As a supervisor, exhibits sound hiring decisions, mentors and develops staff. Provides for succession planning and regular performance feedback to staff.

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing highly talented professionals in the Pharmaceutical and Medical Device industries.

\#IndeedPosting