Exploratory Medicine and Pharmacology Senior Manager
Our client, a global pharma organisation based in Cork are currently recruiting for anExploratory Medicine and Pharmacology (EMP) Manager to join their team on a permanent basis. As Exploratory Medicine and Pharmacology Manager you will be responsible forthequalityand delivery of the clinical trial portfolio.You will also provide leadership withrecruiting/onboarding,inspectionreadiness activities, process improvements, and ensure career development plans are in place.

Responsibilities

• Acts as site leadership for EMP staff
• Work with EMP leadership to represent consistent messages across all global sites
• Leverage technicalexpertiseto coachClinical Trial Project Management Associates toensure plansaredelivered ahead of/to plan and onbudget
• Work with EMP leadershiptoensureplanning databases are accurate andup todate
• Ensure inspection readiness ofstaff’srespective study teamsand participates as needed in mock/realinspections
• Oversee andprovidedirection in obtainingappropriate personnel involvementas compliance issues areidentifiedwhich require further action orfollow-up
• Ensure appropriate escalation of portfolio related issues
• Manage resource needs and trade-offs acrossareas based on priorityto meet/exceed portfoliomilestones
• Facilitate discussions within clinical functionsas neededto manage team priorities and address unplanned demands
• Provide technical coaching andleadership to EMP Operations to enableeffectiveplanning andexecutionof the clinical portfoliotodeliver to meet/exceed milestones
• Ensure quality in clinical research activities by promoting consistent use of GCPs, global SOPs, and bestpractices
• Provides timely communication to staff regarding the strategic direction, realignment of new assignments and new processes
• Facilitates high-level discussions with vendors, as appropriate
• Leads training in study start up processes for staff
• Post vacant positions, coordinate interviews, and lead decisions on hiring staff members with a goal of attracting and retaining top talent in theorganization
• Ensure development plans are in place forstaff
• Evaluate individual skill level and behaviors, identify &appropriate coachesfor staff toenable them to become proficient in completion of study responsibilities
• Monitortraining compliance forassistants ensuringtimelycompletion of all required courses
• Has shared responsibility with training group to ensure that curriculum maps and training programs/courses are maintained appropriately for staffmembersto enable them to perform their job responsibilities. Consult as appropriate on new training programs/courses
• Provide timely communication to staff regarding the strategic direction, realignment of new assignments and new processes
• Facilitate high-level discussions with vendors, as appropriate
• Lead training in study start up processes for staff

• Bachelors or University degree (scientific or health-related field preferred) and 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred)
• Demonstrated technical and process expertise in clinical trial development. Must understand the drug development process and interdependencies of various tasks and functional groups
• Effective communicationskills. Communicates effectively up and down in an organization andmaintainsconfidentiality with respect to strategic and personnel matters.
• Proven ability to coach others & previous supervisory experience
• Strong people and leadership skills with demonstrated ability to influence and lead across clinical functions
• Strong interpersonal, teamwork, and negotiation skills
• Strong self-management and organizational skills.Must be capable of managing staff virtually, demonstratinginclusivebehaviors
• Vendor management and contracting experience
• Demonstrated strong business skills including the ability to understandandsupportplanning processes across clinical functions
• Travel may be required