MAIN PURPOSE OF JOB
- As the Associate Director, Asset Lead you will be accountable to oversee a team of Clinical Program Managers across an Asset or Assets ensuring their clinical programs are delivered to time, cost and quality. You will provide operational expertise and strategic input to the development of the clinical development plans supporting the overall clinical strategy Phase 1-3.
- Accountable for the operational delivery of CPMs and their programs, ensuring all program deliverables and milestones are met with quality and within budget
- Collaborate with cross-functional counterparts to oversee the performance for all activities to deliver programs on time and with qualitParticipate in program strategy meetings, contributing the operational strategy of program/studies.
- Provide direction and support to CPMs for the development of study strategy operational plans including enrolment models and risk management strategy. Ensure consistent approach and process across the portfolio.
- Review and provide expert clinical operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, monitoring plans, Communication plans and project plans.
Support efforts for the selection and oversight of external service providers, including CROs and other vendors as necessary
- Review of study protocols and related study documents, as required, for operational execution.
- Oversight of team’s study execution and procedures as required to ensure regulatory compliance of protocol activities
- Support Clinical Program budget negotiations and management of Clinical Operations spend related to clinical program execution. Works closely with Global Project Managers, Outsourcing Management, and Finance to ensure on a regular basis that budgets are accurate.
- Play an active part in CRO selection and review of RFP’s when required, ensuring the appropriate CRO is identified and properly vetted. Work with internal and external teams as required, ensuring the programs are initiated and managed in line with company strategy and key clinical and regulatory milestones
Supports and participate in request and review of scope of works, budgets, vendor performance and issue resolution
- Identifies and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads as needed
- Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs and consistently across the portfolio.
- Participates and or Leads governance committee with Vendors
- Ensure program meets all GCP/ICH Guidelines and is Inspection Ready
- Leads and/or contributes to department initiatives and assists in the design and implementation of standardized work processes.
- Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones
- Assist in SOP and working instruction development, review and approval
Interpersonal Skills - Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner. Demonstrated effective team leadership in cross-functional matrix teams.
Communication Skills - Excellent oral and written communications with ability to present data to all levels of audiences.
Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to proactively identify and take appropriate initiatives to fulfil the requirements of the role. Ability to maintain a high level of productivity with minimal supervision.
Strategic Thinking – Strong capability of strategic thinking and proposing innovative solutions to issues.
Collaboration & Teamwork – Advanced competence in collaboration & teamwork, communications, influence, conflict resolution, strategic agility, planning & organizing, team building, driving results and problem solving.
Experience & knowledge
- Worked to fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes. Supporting and influencing key stakeholders where required for the successful delivery of projects
- Provided a strong clinical operational focus whilst being able to identify program needs and deliver practical, straight-forward, solutions which work first time
- Vendor Oversight experience
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Understands and applies the principles of GCP. Creating and maintaining healthy, creative, relationships with study sites and principle investigators; helping to support and influence where required
- Proficient in MS Word, Excel, Power Point, Outlook, MS Project, SharePoint
- Experience with immunotherapies in Oncology would be an advantage
Key behavioural attributes
- Attention to Communication
- Managing Self Performance
- Results Orientated
- Written and oral communication
- Building collaborative relationships
- Fostering teamwork
- Influencing others
- Developing others
- Forward thinking
Education & qualifications
- BA/ BS. or higher in a related scientific subject
- 10+ years’ experience in pharmaceutical industry and/or clinical research organization, including majority of years in clinical study/project management. Experience must include early phase clinical studies/Phase I-III studies and global/international studies or programs. Experience in oncology is highly desired.
- Requires approximately 10-15 % travel, including overnight and international travel
Immunocore is an equal opportunities Employer