J&J Family of Companies Head Established Products & CMC support in Raritan, New Jersey
The Global Head of Established Products and CMC Support in Nonclinical Safety (NCS) supports the development of novel therapeutics spanning all therapeutic areas and small molecules as well as biologics through leadership of a global team that manages support to the CMC organization (impurity management, worker safety/occupational toxicology) as well as support with regard to the Established Products portfolio and NCS-related requests by other groups or business units within JNJ. The impurity management and worker safety/occupational toxicology groups are groups that are facing increasing demands in terms of workload on existing projects as well as questions on new modalities in biologics for which pro-activeness is required to ensure patient and worker safety. The support required for establish products may vary from labelling and scientific questions to questions on contaminations/impurities in marketed products, with a global scope and for small molecules as well as biologics. Additionally, requests for NCS support may come in from various angles, including Johnson & Johnson Business Units such as Consumer and Medical Devices, or other Janssen departments, that need coordination and scientific oversight. The Global Head will be responsible to identify and address organizational needs in these spaces, create synergies and an efficient and flexible organization that supports the entire Janssen portfolio as well as NCS related topics from JNJ Business Units, with scientific quality and speed. Excellent collaboration with various global functional groups within Janssen R&D, as well as within Johnson & Johnson business units, will be pivotal.
The Global Head will be responsible for career and talent development and succession planning. He/she has a desire for mentoring, learning, and strives for innovation and continued career development through participation in and presentations at regulatory meetings and/or scientific pharma/industry meetings.
This role is pivotal in assuring a globally integrated approach to address the growing and complex area of established products and CMC support for small molecules as well as biologics (including new modalities), ensuring patient and worker safety and with direct impact on timelines.
Major Duties & Responsibilities
Evaluates gaps and global organizational needs for existing and new modality support (impurity management and worker safety/occupational toxicology; established products) and works with subject matter experts to evaluate and update the strategy for support to ensure high quality and timely output. Identifies and timely addresses potential hurdles that may impact business conduct and ensures processes are aligned to provide deliverables in an efficient way and with high quality
People leader role for a global organization, including hiring, managing and developing staff, succession planning, optimal and global resourcing. Evaluates opportunities for cross-training within the group but also with other groups in NCS to increase efficiency and flexibility.
Responsible for preparation, review and timely and efficient delivery of safety assessment documents for CMC, occupational toxicology and established product support, with high scientific quality. Ensures compliance with global and company guidelines and policies. Ensures optimal collaboration in the groups as well as between this and other NCS groups (NCSLs, Therapeutic Area Leads, submission groups)
Collaborates with non-NCS groups in Janssen such as (but not limited to) CMC, EH&S and with Consumer/Medical Devices on NCS-related support; coordinates this support and maintains scientific oversight to realize synergies and facilitate proper interface and effectiveness of collaborative and consulting partnerships
Stays up to date with regulatory requirements and industry trends, and engages his/her external network to inform strategies.
• MSc or Ph.D. degree in a relevant medical sciences / life sciences area, with 15 + years of experience in pharmaceutical R&D, with focus on Nonclinical safety
• Proven track-record in building and leading complex global teams, including direct people management. Experience with change management as well as building a successful talent pipeline
• Knowledge of impurity management, occupational toxicology and/or established products support is preferred, including knowledge of applicable regulatory guidelines/policies. Scientific curiosity and willingness to explore and develop requirements for new modalities in these areas is key.
• This role requires excellent diplomacy, communication and interpersonal skills, a high level of organizational ability and attention to detail.
• Ability to network across various departments and functional areas within Janssen and JNJ Business Units, as well as networking in relevant communities in industry and regulatory environment.
• Proven ability to motivate teams to work effectively in a collaborative and global environment
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Janssen Pharmaceutica N.V. (7555)