The Senior Director, Global Toxicology, in Nonclinical Safety (NCS) supports the development of novel therapeutics spanning all therapeutic areas and modalities through people leadership of a local team of nonclinical safety leads (NCSL) and by serving as an NCSL him/herselves. The Senior Director assures that NCS scientific toxicology strategies and operational execution are in step with internal guidelines, and clinical and regulatory goals, to deliver our therapeutics to patients in an efficient and robust manner. The Senior Director assures that his/her team is seamlessly, globally connected, efficiently managed, and has a strong talent pipeline that has the nimbleness to support the pipeline, end-to-end.
In partnership with NCS Therapeutic Area Leaders and NCS functional area management, the Senior Director ensures that NCSLs are well positioned to develop, implement and evaluate nonclinical safety de-risking strategies from discovery through post-marketing approval. He/she will manage 8 – 10 direct reports in a single region and will strongly interact with his/her peers at other R&D sites. The Senior Director has accountability for globally improving and aligning processes to assure optimization of people resource, future capacity planning, budget, resource and timeline commitments for the group. He/she has responsibility for career and talent development, as well as succession planning, to create a team that can deliver the diverse and broad portfolio on short and long term. Responsibilities includes scientific, regulatory and soft skill coaching as well as assurance of delivery of high-quality presentations and written documents including regulatory documents by the NCSLs in his/her team. The Senior Director encourages partnering of NCSLs with appropriate functions within and outside NCS, emphasizing the importance of global multidisciplinary collaborations across regions and departments. The Senior Director will also partner with peers in other DPDS departments, therapeutic areas, regulatory and clinical functions to assure efficient processes and provision of scientific input by/to their staff.
The Senior Director has a desire for teaching, learning, and innovation and continue career development through participation in and presentations at regulatory meetings and/or scientific pharma/industry meetings. The latter is critical to help gain broader consensus and support of new approaches by the regulatory community and for recruiting future talent.
- People leader role for the NCSL team in Beerse (8 - 10 NCSLs direct reports but also indirect management of NCSLs residing in other functions), including hiring, managing and developing staff, succession planning, as well as coaching on scientific development and soft skill development.
- Accountable for toxicology output (plans, safety assessments, regulatory submissions documents) being delivered with high quality and maximal efficiency, high regard to 3R’s, and with appropriate risk taking and with impact towards the portfolio by driving internal decision making and regulatory acceptance of submissions. Ensures clarity of communication of cohesive story for audience that is beyond NCS.
- Assures appropriate staffing of NCSLs in R&D teams, as well as appropriate and timely execution of strategies. Develops strategies for assuring proactivity in pipeline work, anticipates future modality needs, engages external network to inform research priorities.
- Assures close collaboration with relevant functions, in particular with peers, NCS Therapeutic Area Leaders and NCS functional area leaders. Strong understanding of DPDS and other relevant organizations to facilitate proper interface and effectiveness of collaborative and consulting partnerships and to serve as thought leader providing ideas on portfolio/collaboration strategies.
- Serves as an Non Clinical Safety Lead
- Ph.D. in toxicology, pathology, veterinary or clinical medicine, biochemistry, immunology, cell biology, pharmacology, toxicology or related discipline (bioengineering, medicine, veterinary science or related field) and/or professional degree (DVM, MD) with training or extensive experience in cell and molecular toxicology or related biologic disciplines
- 15 + years of pharmaceutical/biotechnology research management coincident with experience in drug development and nonclinical safety project management in particular. Strong preference for experience in drug development of both small molecules and large molecules/new modalities.
- Proven track-record in leading complex teams, including direct people management.
- Exceptional diplomacy and negotiating skill.s
- Excellent communication and interpersonal skills, a high level of organizational ability and attention to detail.
- Strong ability to work effectively in a collaborative and global environment .
Janssen Pharmaceutica N.V. (7555)