Job Title*:Project Lead (PL) Supervisors’s Title: Project Head, AP Development
Development Office: AP Development
Country: China Date: March 15, 2019
JOB PURPOSE/ COMPANY RELATIONSHIP
This position belongs to Asia Pacific (AP) Development. The mission of this department is to accelerate geographic expansion (AP Expansion) of new products through global simultaneous development (GSD) or regional parallel development; and to maximize Life Cycle Management of existing products (LCM). The mission of the position includes both clinical research leadership and project direction leadership.
Clinical Research Leadership (70%): Be responsible for the clinical development strategy and planning, each study design, execution of clinical development plans, direction for regulatory submission from clinical perspective, and responces to health authority (HA)’s clinical and/or medical questions leading to regulatory approval in AP countries. The position is also responsible for supervision of the set-up, implementation, conduct, analysis and reporting of those clinical trials.
Project Leadership (30%): Be responsible for leading development projects from entry into development to successful approval (and through critical LCM activities). It will lead the Project Team in the creation of a project strategy documented Plan and directs a cross-functional Project Team to assure the successful completion of projects according to rigorous scientific and regulatory standards within agreed upon timelines and budgets. Actively directs the project for completion of milestones and actively addresses any deviations from the plan that would trigger review of the project by the appropriate management committees. Leads the preparation of the documentation and coordinates the presentation of the project and possible contingency plans to management committees. In collaboration with the respective functions, the Project Lead facilitates the creation of resource and budget plans for review by management committees.
The incumbent can take the position of CL for a couple of projects and postion of PL for another project, mostly early projects.
(See Organizational chart attached)
This is an individual contributor role.
(Sales, budget, headcount…)
- As CL (70%):
- Be capable of planning and directing a clinical program leading to regional regulatory submissions. This entails writing the clinical part of the Integrated Development Plan (IDP), protocol Extended Synopsis (ES), briefing package for meeting/consultation with HA, supervising the writing of the full study protocol, writing and/or directing Common Technical Document (CTD) clinical module, responces to HA inquries/deficiency letter in order to surely register the drug with appropriate scientific justifications.
- To coordinate and to supervise the conduct of clinical trials in compliance with Sanofi SOPs as well as institutional and governmental regulations and in close collaboration with the Clinical Study Director (CSD) and the Clinical Operations Group in order to ensure the completion of these trials with required quality and in a timely fashion. Supervise the writing of the Key Result Memo and of the Clinical Study Report.
- Serve as medical and scientific expert for the clinical programs and be responsible for the ongoing review of clinical trial data as regards to quality and in accordance with Asia Pacific regulations and ICH.
- Select, in collaboration with the Clinical Science & Operations platform, the investigator centers participating in these studies.
- Direct and take all responses – clinical part - in the building of AP registration dossier in close relationship with the Project Lead, Regulatory Affairs, and other key contributors.
- Interact with the Pharmacovigilance department to ensure that the serious adverse events occurring in clinical trials are followed up, evaluated, reported to regulatory authorities and notified to investigators promptly. Collaborate with Pharmacovigilance in the timely and accurate follow-up of the patient safety (e.g. adverse events) in clinical trials, ensure the data surveillance plan and the risk management plan, if any is implemented and conducted.
- Participate in written and oral presentations to experts and investigators, to business partners, and to regulatory bodies involving discussion of the clinical issues relating to the project.
- As PL (30%)
- Project Strategy:
Directs the creation of an IDP to translate the overall project strategy and scope into an executable development plan in AP region and countries. Leads the implementation of cross-functional Project Team at the start of a new project. Upon arrival of new team members, in collaboration with functional management trains the team member on project-specific issues and assures optimal integration into the team.
- Operational Management:
- Manage / coordinate the operational activities through a team approach in order to efficiently and diligently implement the development plan. Motivate and encourage team members with the goal of creating an ambitious, scientifically rigorous development team. In collaboration with the Operation Director, monitor, anticipate, and track any deviation from the agreed plan (time, risk, scope). Anticipate needs for a contingency plan and have such a contingency plan ready by the time the anticipated issue is faced. Work with team members and function heads to ensure the project is adequately resourced and all project milestones are completed as planned. Proactively identify potential issues and manage cross-functional and cross-cultural resolution.
- Drive project progression along the value chain through a team approach, in order to efficiently and diligently implement the development plan. Prepare, manage, and minute project team meetings on a regular basis. Organize and facilitate ad-hoc operational meetings, when needed. Co-Chair the CTD submission task force. Represent AP Development vis a vis Medical & Marketing, Pharma Operations and BUs (if any) in the AP region/countries, represent AP Development in the global Project Team as key member of this Project Team..Proactively identify potential issues and manage cross-functional resolution, as well as all cross-functional team activities including Business Unit/Division, Discovery, Preclinical, Regulatory affairs, Quality, Pharmacovigilance, and other key R&D departments , if applicable (e.g. CSO, CMC, DSAR).Ensure that team activities are in line with the overall timelines of the development plan in order to meet agreed project milestones.Foster trust, transparency, and cohesion within the team to ensure efficient communication channels with team members.Monitor resources required to complete activities as agreed, and work with each functional representative on the team to achieve this. Prepare project progression reports and present to management committees on regular project updates, milestone decision points, or on occasion of project deviations.
- In close collaboration with the Operation Director and team members, assume responsibility for the preparation and quality of the following documents, e.g. IIDP; Presentation to Management Board, including Position Papers; Project Team Objectives; Executive Summaries and minutes/actions of Project Team meetings. Supervise the completion of clinical overview, clinical-regulatory documents (such as investigator’s brochure, benefit/risk assessment, briefing package for health authorities, etc..) Full director level: proven ability to independently develop above mentioned documents up to a quality ready for management sign-off.
- Use judgment and expertise in executing agreed strategy. Anticipate significant issues for discussion and resolution by clinical teams or management, as appropriate.
- Authority to implement strategy as defined in approved IDP.
- Negotiate resource conflicts with functions.
- Implementation of strategic changes / addressing of emergent issues require close interaction with superior/appropriate management committees.
- Full director level: upon delegation by superior, assume leadership role in critical project-tasks, including key alliance interactions.
PARAMETERS FOR SUCCESS:
- Key Metrics
- Number of programs through phase transition, successful HA meeting, successful NDA approval.
- Network with internal stakeholders: Business Unit/Division, Discovery, Preclinical, Regulatory affairs, Quality, Pharmacovigilance, Medical and Marketing and other key R&D departments to provide direction for AP projects and clinical research activities within the therapeutic domain.
JOB-HOLDER ENTRY REQUIREMENTS:
- Scientific degree (Ph.D.; M.D.; Pharm. D.).
- Certification in relevant medical or scientific specialties is a plus
- Other degrees may be acceptable as scientific qualification if supplemented by appropriate, documented on-the-job scientific expertise.
- Business degree / training (desired, but not necessary).
Experience & knowledge:
- 7+ years in pharmaceutical industry; 5+ years in global/clinical drug development (preferred); 3+ years in project management, as Project Manager (preferred). Strong medical background
- People / Team Management skills:
Ability to lead and challenge multifunctional teams; conflict resolution, and ability to facilitate decision-making; ability to conduct effective meetings; ability to work effectively in cross-cultural environments.
- Technical Competencies in areas such as: Drug development including experience with clinical projects; clinical development planning, clinical direction for NDA/BLA registration, project management; scientific knowledge and experience; budget management; resource management;
- Operational Competencies: Performance-oriented, and achievement-oriented, audacious; familiar with details of drug development process; analytical and troubleshooting competencies; creativity and common sense; issue and conflict analysis; able to communicate and negotiate across all levels of organization; ability to operate in an international and cross-functional environment; professionalism and demonstrates solidarity with organization and team members; customer focus; interpersonal savvy with respect for people; good communication skills (written and oral).
- More specifically from Clinical Research view point:
- strong medical background particularly in hematology, rare blood disorder or rare diseaseas well as a very good understanding of the drug development process and the regulatory framework for clinical trials.
- The ability to interpret clinical data accurately is essential.
- Strong verbal and written communication skills in English and local language (such as Chinese, Japanese, etc) are required to complement the ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions.
- Good knowledge and experience with the process of data collection, management, and analysis are required for direct and indirect management of this process.
- Good negotiation and persuasion skills are important.
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