Senior Scientific Director (China CRO Lead)-00000SKG
Description
A. Basic function and scope
The cc is a key position in the scientific leadership of API Small Molecule Development, with primary responsibility for managing strategic and day-to-day projects and specifically for this function, overseeing development activities performed at external partners in China (typically CROs, and on an ad-hoc basis, CMOs).
•Together with the Vice President of API Small Molecule Development, responsible for: providing a scientific vision for the department, strengthening the scientific cability of the organization to meet project deliverables and accelerate timelines, consistently meeting customer and business partner requirements and supporting scientific and technological innovation; enabling business growth and the capability to develop a best practice organization.
•Also responsible for providing scientific leadership in support of API SM activities at external partners, specifically in China, both with a project focus and also managing/facilitating interactions between Discovery and Operations stakeholders, and internally within the Janssen CMC organisation (Pharmaceutical Development and Manufacturing Sciences; PDMS). PDMS partners would include API SM Integrators and Single Points of Contact also multi-disciplinary and multi-site groups involving both internal resources and external partners.
B. Specific duties
1.Regular oversight and on-site supervision of development activity at external process R&D teams, which includes responsibility for project and resource allocation in collaboration with the management team of the CRO in question
2.Contribution to the selection, recruitment and training and evaluation of CRO personnel in addition to allocation of R&Rs in the team.
3.Accountable for the execution of projects allocated to the team and for ensuring the proper recording of information. Ensures that records and raw data are properly retained. Summarizes, interprets, and reviews data.
4.Ensures the proper and timely preparation of technical reports, manuscripts, and other documents. Consistent with company policy, publishes work in scientific journals. Must have good writing skills.
5.Effectively applies state of the-art scientific knowledge to own or assigned project. Demonstrates considerable knowledge/expertise outside of own field, especially in bridging disciplines. Introduces new approaches to the solution of problems.
6.Must be able to lead teams as needed and assume a (typically scientific) leadership role as either Science Advisor, Technical Integrator, Chemistry Lead, or Single Point of Contact, and establish priorities, checkpoints, and time frames for all aspects of work and projects to achieve adequate progress.
7.Keeps abreast of current scientific and managerial developments and new techniques by reading the current literature broadly, and by interacting with outside experts. Establishes and maintains outside expert contacts. Seeks and utilizes the advice of expert scientists and outside consultants to guarantee efficient and successful projects. Ensures application of all relevant literature search methodologies to drive current projects and to support the development of new ideas. Consults effectively on managerial, technical and conceptual planes with colleagues in own team, as well as other teams and departments.
8.Advises PDMS and CRO management of facilities needed to accomplish tasks. Ensures availability of adequate materials. Recommends and justifies the purchase of capital equipment. Is responsible for long range planning. Organises required budgetary information.
9.Attends in house seminars; local, national and international managerial and scientific meetings, in own or allied field. Presents own work at in house research forums, to department, to outside consultants, and at external meetings and conferences. Has good oral presentation skills. Serves on an as-needs basis as a member, a co-leader or leader of a Research Team and/or member of a Development Project Team.
10.Trains and directs laboratory personnel at external partner. Delegates work assignments effectively.. Strives with supervisee and external partner management to achieve: high level of performance evaluation and development, open communication and mutual respect.
11.Participates in discussions at management and research meetings, thereby sharing information, knowledge, ideas, and judgement to guide and help establish valid strategic and scientific directions. Contributes to the formulation of goals of own division, both overall and specific, through established forums and own initiative.
12.Ensures that new inventions and discoveries are properly documented as evidence of invention and reduction to practice.
13.Ensures that work adheres to established operating procedures and safety regulations adhering to company work standards.
14.Ensures full attention to oversight of GXP aspects at level appropriate to the activity in question, and in collaboration with (and guided by) Quality organisations of both Janssen and the external partner.
15.Performs other duties within and outside PDMS, appropriate to level of experience, and as assigned.
Qualifications
Normally will have the following minimum entry requirements:
a Ph.D. degree in organic chemistry with > 15 years of experience (including postdoctoral studies) within the pharmaceutical and/or fine chemical industries in a development environment, ideally with both early and late development exposure. Experience in initiating and managing external partner activity is essential and manufacturing experience is a plus. In addition to the above, the incumbent:
•Must demonstrate good skills for organising, planning, and problem solving.
•Must provide leadership and development to supervisee(s).
•Must be able to interface with people of various groups and disciplines.
•Must provide leadership to research team and division.
•Must espouse the fundamental importance of the “scientific method” to research.
•Must maintain a high level of professional ethics.
•Has a demonstrated ability to translate creative and innovative approaches into the solution of problems and the timely advancement of projects.
•Is able to write reports and deliver presentations that are clear, organised, focused, and intellectually sound.
•Can readily conduct strategic and/or scientific projects in an organised and productive manner.
•Shows a high sense of responsibility regarding scientific and professional activities.
•Exerts a major presence within the company.
•Has made significant added-value contributions to the company in terms of new or improved products, processes, and/or methods.
A sustained record of significant scientific and/or managerial contributions to projects/programs of PDMS, Drug Discovery and/or Operations
Proven creativity, originality, and productivity.
A high level of peer recognition as a respected scientist, at least within own division.
Recognition in the external scientific community, ideally based on a track record of peer-reviewed publications, and participation in scientific forums.
Concrete added value contributions to the company in terms of new or improved products, processes, and/or methods (scientific and technological).
Primary Location:Asia Pacific-China-Shanghai
Other Locations:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical China (7052)
Job Function: Biology
Description
A. Basic function and scope
The cc is a key position in the scientific leadership of API Small Molecule Development, with primary responsibility for managing strategic and day-to-day projects and specifically for this function, overseeing development activities performed at external partners in China (typically CROs, and on an ad-hoc basis, CMOs).
•Together with the Vice President of API Small Molecule Development, responsible for: providing a scientific vision for the department, strengthening the scientific cability of the organization to meet project deliverables and accelerate timelines, consistently meeting customer and business partner requirements and supporting scientific and technological innovation; enabling business growth and the capability to develop a best practice organization.
•Also responsible for providing scientific leadership in support of API SM activities at external partners, specifically in China, both with a project focus and also managing/facilitating interactions between Discovery and Operations stakeholders, and internally within the Janssen CMC organisation (Pharmaceutical Development and Manufacturing Sciences; PDMS). PDMS partners would include API SM Integrators and Single Points of Contact also multi-disciplinary and multi-site groups involving both internal resources and external partners.
B. Specific duties
1.Regular oversight and on-site supervision of development activity at external process R&D teams, which includes responsibility for project and resource allocation in collaboration with the management team of the CRO in question
2.Contribution to the selection, recruitment and training and evaluation of CRO personnel in addition to allocation of R&Rs in the team.
3.Accountable for the execution of projects allocated to the team and for ensuring the proper recording of information. Ensures that records and raw data are properly retained. Summarizes, interprets, and reviews data.
4.Ensures the proper and timely preparation of technical reports, manuscripts, and other documents. Consistent with company policy, publishes work in scientific journals. Must have good writing skills.
5.Effectively applies state of the-art scientific knowledge to own or assigned project. Demonstrates considerable knowledge/expertise outside of own field, especially in bridging disciplines. Introduces new approaches to the solution of problems.
6.Must be able to lead teams as needed and assume a (typically scientific) leadership role as either Science Advisor, Technical Integrator, Chemistry Lead, or Single Point of Contact, and establish priorities, checkpoints, and time frames for all aspects of work and projects to achieve adequate progress.
7.Keeps abreast of current scientific and managerial developments and new techniques by reading the current literature broadly, and by interacting with outside experts. Establishes and maintains outside expert contacts. Seeks and utilizes the advice of expert scientists and outside consultants to guarantee efficient and successful projects. Ensures application of all relevant literature search methodologies to drive current projects and to support the development of new ideas. Consults effectively on managerial, technical and conceptual planes with colleagues in own team, as well as other teams and departments.
8.Advises PDMS and CRO management of facilities needed to accomplish tasks. Ensures availability of adequate materials. Recommends and justifies the purchase of capital equipment. Is responsible for long range planning. Organises required budgetary information.
9.Attends in house seminars; local, national and international managerial and scientific meetings, in own or allied field. Presents own work at in house research forums, to department, to outside consultants, and at external meetings and conferences. Has good oral presentation skills. Serves on an as-needs basis as a member, a co-leader or leader of a Research Team and/or member of a Development Project Team.
10.Trains and directs laboratory personnel at external partner. Delegates work assignments effectively.. Strives with supervisee and external partner management to achieve: high level of performance evaluation and development, open communication and mutual respect.
11.Participates in discussions at management and research meetings, thereby sharing information, knowledge, ideas, and judgement to guide and help establish valid strategic and scientific directions. Contributes to the formulation of goals of own division, both overall and specific, through established forums and own initiative.
12.Ensures that new inventions and discoveries are properly documented as evidence of invention and reduction to practice.
13.Ensures that work adheres to established operating procedures and safety regulations adhering to company work standards.
14.Ensures full attention to oversight of GXP aspects at level appropriate to the activity in question, and in collaboration with (and guided by) Quality organisations of both Janssen and the external partner.
15.Performs other duties within and outside PDMS, appropriate to level of experience, and as assigned.
Qualifications
Normally will have the following minimum entry requirements:
a Ph.D. degree in organic chemistry with > 15 years of experience (including postdoctoral studies) within the pharmaceutical and/or fine chemical industries in a development environment, ideally with both early and late development exposure. Experience in initiating and managing external partner activity is essential and manufacturing experience is a plus. In addition to the above, the incumbent:
•Must demonstrate good skills for organising, planning, and problem solving.
•Must provide leadership and development to supervisee(s).
•Must be able to interface with people of various groups and disciplines.
•Must provide leadership to research team and division.
•Must espouse the fundamental importance of the “scientific method” to research.
•Must maintain a high level of professional ethics.
•Has a demonstrated ability to translate creative and innovative approaches into the solution of problems and the timely advancement of projects.
•Is able to write reports and deliver presentations that are clear, organised, focused, and intellectually sound.
•Can readily conduct strategic and/or scientific projects in an organised and productive manner.
•Shows a high sense of responsibility regarding scientific and professional activities.
•Exerts a major presence within the company.
•Has made significant added-value contributions to the company in terms of new or improved products, processes, and/or methods.
A sustained record of significant scientific and/or managerial contributions to projects/programs of PDMS, Drug Discovery and/or Operations
Proven creativity, originality, and productivity.
A high level of peer recognition as a respected scientist, at least within own division.
Recognition in the external scientific community, ideally based on a track record of peer-reviewed publications, and participation in scientific forums.
Concrete added value contributions to the company in terms of new or improved products, processes, and/or methods (scientific and technological).
Primary Location:Asia Pacific-China-Shanghai
Other Locations:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical China (7052)
Job Function: Biology