Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Associate Director Pharmaceutical Developability located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Within Discovery, Product Development & Supply, the Small Molecule Drug Product Development organization has an open position for Associate Director Pharmaceutical Developability.
The position will be accountable as of Lead Optimization for the developability profiling of key compounds of interest within Janssen's Discovery portfolio. In this position, you will partner with Discovery to help guide and influence the optimal design and selection of New Molecular Entities (NMEs) and ensure identification of the best compounds for progression into clinical development in line with the Disease Area Stronghold (DAS) and Therapeutic Area (TA) Strategy. Furthermore, this leader will assure formulation development strategies up to First in Human (FIH) clinical studies, also taking into consideration later formulation trajectories.
As part of the Global Developability team, you will work closely with the Global Head of Small Molecule Pharmaceutical Developability providing strategic and scientific mentorship and guidance to the Spring House Developability Department and will collaborate closely with key partners in both the Discovery and the Development organizations. This role will enable the you to build strong partnerships with key stakeholders within Discovery, Nonclinical Safety, Product Development, Drug Metabolism and Pharmacokinetics, and other key functions across Janssen R&D.
You will assist in Discovery Sciences management and participate in relevant Discovery-TA governance bodies where you will drive effective decision-making and ensure the optimal transition of compounds from the discovery portfolio (internally and externally) to NME selection and into clinical development. You will be part of a dynamic, accomplished Developability team that supports multiple R&D therapeutic areas across Discovery, and you will contribute to data-driven solutions that enable the Discovery portfolio.
As part of a Global Developability Team, you will provide strategic support to the department, will help to direct key growth initiatives, and will drive the development of appropriate new capabilities to fully enable Discovery efforts within Janssen R&D and at the Spring House site. You will also be involved in oversite of Developability work conducted at key external organizations.
The Developability teams will reside on the discovery teams and will be an integral contributor to these teams, enabling evaluation of efficacy, safety, and a number of Developability criteria to ensure appropriateness for progression of key discovery molecules into development. In this role, you will ensure rapid access to various formulation capabilities/approaches including various routes of administration including oral, intravenous, intramuscular, ophthalmic, and inhaled. Experience with formulation of poorly soluble small molecules is highly preferred as well as formulation strategies to enhance absorption of peptides, protein degraders (PROTACS), delivery of oligonucleotides, and siRNAs is highly desirable. Knowledge and understanding of liposomal formulation strategies and the use of amorphous solid dispersions for enhancing delivery of poorly soluble molecules is also highly desirable.
Further key accountabilities/responsibilities details:
- Assess Lead to Late-Lead candidates within discovery using state-of-the-art tools and approaches.
- Actively connect and engage key Discovery partners, Therapeutic Areas, Pharmacokinetics, Toxicology, and Product Development teams.
- Stay informed on and invest in innovative screening tools and formulation options to meet the needs of the Discovery programs, in collaboration with experts within Janssen R&D, academic institutes and contract labs.
- Provide strategic and scientific guidance and mentorship to a team of scientists (developability representatives, formulators) and lab technicians
- Help guide developability input into Janssen’s data science initiatives and contribute to the development and use of data and computational models.
- Opportunity to significantly influence the scientific and strategic direction of the Developability team. You will have the opportunity to help ensure world-class support of the Discovery portfolio, to cultivate collaboration across multiple teams, and improve scientific expertise.
- Represent Drug Product Development on various Discovery programs ensuring relevant Pharmaceutical Development input & emphasizing key risks with a goal of identifying the best compounds for development. The candidate will be accountable for assessing developability of New Molecular Entities in small molecule design, will be accountable for polymorphic form and salt selection, and will determine formulation strategies to support both safety assessment & FIH clinical studies. Be a key decision maker in candidate evaluations, selection, and advancement.
- Maintain an up to date knowledge of cutting-edge advances in developability and formulation sciences to ensure maximal performance of the organization. Provide oversite and guidance of key initiatives associated with Developability capabilities including the use of automation, data analytics & prediction, and key formulation tools to enable the Discovery portfolio. Assist the Global Head of Developability in maintaining and building external global networks to ensure access to and collaboration with world leading scientists (academic, government, and industry).
- Provide timely and informative updates to the Global Head of Developability, Spring House Developability team and on assigned Discovery teams to ensure understanding of progress, portfolio, risks, and challenges.
- Actively encourage and support career growth for scientific leaders within Developability. This role will likely have direct reports where mentorship and guidance will be required. Serve as a matrix leader to help embed understanding of key developability criteria within Discovery teams. Support a high performing organization with emphasis on innovation and scientific excellence as recognized by internal and external partners.
Required Knowledge, Skills and Abilities:
A Ph.D. degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering with 10+ years of relevant experience, or proven equivalent experience desirable.
BS or MS with robust experienced and understanding of Developability within the Pharmaceutical industry preferred.
A strong understanding of Late Discovery and Pharmaceutical Development such as ADME, Preclinical Safety evaluation and Drug Development required.
Demonstrated experience in developability or assessment of New Molecular Entities (NME) for druggable characteristics (e.g. molecular design and interpretation of pharmaceutical properties in relation to exposure and toxicology data, formulation strategies and optimal dosage forms required.
Strategic and broad technical and scientific leadership capabilities; ability to guide/support/oversee delivery of technical initiatives or new capabilities for the organization required.
Good understanding of global regulatory requirements and ability to respond to questions from Regulatory Agencies preferred.
Experience in matrix leadership and collaborative initiatives, strong managerial competencies required.
Excellent partnering and decision-making skills required.
Understanding and experience with the use of predictive models and data science preferred.
Negotiate and influence decision-making processes, think and manage through issues into resolution, lead scientific discussions required.
Excellent oral and written communication skills and ability to clearly and concisely present and communicate developability assessment and its impact to various audiences, including medicinal chemists, biologists, preclinical leaders, development leaders and internal management boards required.
Ability to connect and empower people, discover and develop potential and challenge in a positive manner where necessary required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)