Executive / senior industry position
A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
- Lead one or more global drug development or lifecycle management project teams as defined by RDC governance, executing the program strategy for the specific project, according to the TPP (Target Product Profile).
- Partner with the Global Project Lead and/or Program Lead in defining the overall program strategy, stakeholder management and overall program leadership topics, including fit-for-purpose GPT (Global Program Team) and/or Local Project Team organization.
- Provide operational leadership to projects of a complex, multi-asset team and lead development of the clinical operational strategy (comprising of multiple trials, and/or multiple indications).
- Ensure an efficient information flow within the local cross-functional project team, and ensure local regulatory and other requirements are communicated to GPT and incorporated into the global program strategies.
- Provide inspirational leadership to the team to achieve superior performance.
- Accountable for individual project delivery within the program strategy with particular focus on delivery of clinical development plan within the budget, timelines and quality standards.
- Direct the global cross-functional project team at R&D Hub leveraging project management and drug development expertise and coach, mentor and engage project team members, ensuring efficient and effective project team operation.
- Lead Clinical Operations Expert Team as appropriate, ensuring seamless communication between GPT and expert team level.
- Provide guidance and leadership support to Global Clinical Trial Leads (CTLs) and other members of the Clinical Operations Expert Team within the assigned program/project.
- Coach and mentor junior project managers.
- Represent Clinical Operations and Project Management within the Global Program Team (GPT) and serve as the key operational point of contact for the program.
- Contribute to performance appraisal of the team by development of annual program objectives and providing input to assessment of key GPT and Clinical Operations Expert Team members.
- Ensure an efficient information flow within the global cross-functional project team, which can be spread across various R&D hubs/countries.
- Lead the global project team through the preparation and update of key project documents (TPP, iDP, GPT charter, etc.) and perform high-level review in the development of key clinical trial documents such as protocols and CSRs. Contribute to and/or review compound level documents such as Investigator Brochures, DSURs, briefing books.
- Coordinate compilation of GPT contract with governance and ensure execution in line with agreed framework.
- Lead the project valuation to provide data to portfolio management as part of the company’s strategic planning process.
- Drive evaluation of alternative development scenarios including contribution by Clinical Operations (comprising costs, timelines, risks, and project valuation) before approval of the project strategy by the respective governance body.
- In alignment with the program lead manage the internal (top management) and external (investors, scientific community) project reporting and communication.
- Lead development and maintenance of project plans that depict the activities in line with the approved global development strategy as documented in the integrated Development Plan (iDP).
- Provide expert leadership and contribution to all operational aspects of the program budget, including oversight of individual trial budgets and forecasts to ensure delivery within the R&D financial standards.
- Present project plan and status, including proactive communication of budgetary and timeline variances to the relevant governance bodies for approval whenever required by the committee or the relevant governance rules.
- Accountable for the successful preparation and presentation of operational content at key governance discussions (FIH, dPoC, DSC, etc.). Ensure critical support is provided to Clinical Trial Leads in order to drive comprehensive, strategic discussions at governance meetings.
- Ensure high-quality project risk management according to company guidelines.
- Ensure the compliance of the project team with applicable legal and regulatory requirements on a global level and ensure oversight, review and delivery of program CAPAs in order to meet corporate compliance standards and timelines.
- Ensure seamless transition of project(s) to post-dPoC phase following respective governance decision.Support the development and implementation of strategic and/or functional initiatives including input on certain SOPs, processes, and workstreams; Lead implementation of the initiatives in R&D Hub
- Project Management responsibilities may expand from local to regional or global as appropriate based on business needs.
- Develop clinical operations strategies and drive clinical trial execution as required based on business needs
- Take on study management responsibilities as Clinical Trial Lead as required based on business needs
PM3 – Associate Director, China R&D Project Leader
- Manages projects/work streams with low to moderate complexity, risk, impact and reach. Manages a medium-sized project team with members also from outside the direct working environment. Coordinates stakeholders from closely related areas or even beyond.
- Accountable for successful project execution including definition of milestones. May also include clarification of project scope. Receives minimal guidance or works independently. Acts as a senior advisor and mentor within the team and beyond and may even serve as best practice resource within own discipline or as technical expert on crossfunctional teams or projects.
- Manage individual global cross-functional project budgets, including clinical trial budgets.
- Responsible for a cost-effective approach to all development plan activities.
- Accountable for quality sign-off of financial data for OP in respect of the project.
- Take accountability for the cross-functional quality of iMAP data in the context of OP planning.
The China R&D Project Leader
- is responsible for the operational leadership of one or more drug development or lifecycle management projects on a global level, exercising control over sizeable resources, supporting and funding projects, products, services or technologies within the sub-function and by developing policies and plans.
- drives the clinical operations aspects of the strategy within the cross-functional program team
- leads the respective cross-functional project teams at R&D Hub through the execution of the project strategy and interacts closely with the respective global project lead and/or program lead who is responsible for the strategic direction and overall program leadership
- is accountable for end results of the team in respect of the specific project.
- is the key contact on a project level both for internal partners as well as, in the case of co-development projects, for the respective counterparts in the other company
- is a member of the GPT for the drug development program
- oversees the respective functional sub-teams of the global cross-functional project teams and coaches and directs the sub-team leads to achieve timely completion of their respective work packages
- is responsible for the budget and overall timelines and deliverables of the respective project
- is accountable for the quality of financial planning data for the OP in particular for lifecycle management projects
- ensures appropriate risk management and issue resolution on the project level
- is responsible for timely reporting of the project status to the program lead, governance bodies and key stakeholders as needed.
- provides the project management expertise and leadership to enable efficient development of new drugs with the respective project teams and in line with global and local industry benchmark data for timelines, costs and quality
- leverages strategic knowledge and serves as subject matter expert across TA portfolio for current drug development/clinical trial management processes, regulations, and therapeutic knowledge
- provides input into the improvement of project management principles within Healthcare.
- provides strategic leadership to GPT on drug development, clinical operations, and governance interaction.
- develops innovative clinical operation strategies (including patient access and feasibility plans) across multiple indications, trials, and geographies
- provides key learnings and best practices from the project teams into the organization to increase efficiency of drug development
- Project management responsibilities may expand from local to regional or global as appropriate based on business needs
- Develop clinical operations strategies and manage clinical trials as required based on business needs
PM3 – Associate Director, China R&D Project Leader
Impacts through successful execution of projects, handles staff management issues. Handles sensitive issues or even guides, influences and convinces others, in particular colleagues in other areas as well as external customers or agencies. May also contribute to value-added perspectives or advisory services that are important to decision making.
Scope of people responsibility:
Matrix Management of People
- Independently lead an interdisciplinary global and local project team and Clinical Operations Expert Team without direct reporting lines
- Together with program lead responsible and accountable for project objectives setting and performance review of team members (providing input into the HR performance management process for the team members)
- All L2 functions in R&D, with frequent contact at L1 level
- All development functions in GHO
- Global and local R&D controlling
- Legal, Patent, Communications, etc.
- Partner Companies in co-development projects
- Representatives from service providers, particularly from CROs
- External consultants for the respective projects
Education / Work Experience
- Candidate should have a Masters’ degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals); PhD in Life Sciences preferred.
- Professional Project Management certification or qualification (e.g. PMI, IPMA) highly desirable
- Highly developed written and verbal communications skills in English, working knowledge of Chinese an advantage
- Working experience in cross-functional and international global and local drug development teams with demonstrated success.
- Cross-functional knowledge of the Drug Development Process and Drug Development Regulations.
- Deep knowledge of and /or experience in project management, spreadsheet and database management software is required.
- Broad clinical operations experience.
- Comprehensive understanding of finance and accounting principles in an industrial setting
- Experience in financial valuations of projects, risk management, decision making, and scenario thinking
PM3 – Associate Director, China R&D Project Leader
- Minimum of eight (8) years of experience in R&D and/or drug development in the global pharmaceutical industry with at least 3 years direct experience of leadership in a project management related discipline, with clear potential for leadership roles in the future.
- Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Requires senior knowledge and experience in own discipline and beyond which may also require good market and competitor knowledge
Job Specific Competencies and Skills
- Strong interpersonal skills in a multi-cultural environment
- Strong leadership skills in a matrix environment
- Advanced project management skills
- Strong scientific knowledge of drug development
- Problem solving and analytical skills
- Substantial strategic thinking skills
- Robust organizational skills
- Expertise in Clinical Operations
- Excellent communication and influence management skills
- Strong facilitation skills
- Sense of accountability and goal-orientation
- Strong English language skills, with fluency in Chinese language desirable
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