Director Pharmaceutical Developability
Director Pharmaceutical Developability
Locations: Beerse, Belgium
Functions: Product Development
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Requisition ID: 1905761912W
Within Discovery, Product Development & Supply, the Small Molecule Drug Product Development organization has an open position for 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 Developability Department, to the Discovery and the Development teams and organization. This role will enable the you to build strong partnerships with key stakeholders within Discovery, Nonclinical Safety, Product Development, 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 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 direct key growth initiatives, and will drive the development of appropriate new capabilities to fully enable Discovery efforts within Janssen R&D. 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 know-how, enabling technologies and lab capabilities in the various Centers of Excellence in Discovery and within the Product Development organization across the various internal/external sites.
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.
Approximate Percentage of Time
Portfolio Management & Governance - Represent Drug Product Development on various cross Discovery-Development-TA governance bodies, related to NME developability, NME selection and early development formulation strategies. Be a key decision maker in candidate evaluations, selection and advancement, as well as portfolio prioritization and strategy.
Capability Building -Maintain an up to date knowledge of cutting-edge advances in developability 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).
Communications - Provide timely and informative updates to the Global Head of Developability, Drug Product Development and Small Molecule Product Development (SMPD) leadership team, Discovery and DAS Heads on progress, portfolio, risks and challenges.
Talent Development - Actively encourage and support career growth for scientific leaders within Developability. 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 Minimum Education: Ph.D or Equivalent
Required Years of Related Experience: 10+ years
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.
Travel on the Job
Type of Travel Required:
Domestic (US) Yes
People Management Experience:
Required Years of People Management Experience:
Needs to show experience in leading scientists at principal scientist / senior scientist level within matrix environment or overseeing development and delivery of technical initiatives & capabilities
Preferred Knowledge, Skills and Abilities:
* A strong understanding of Late Discovery and Pharmaceutical Development such as ADME, Preclinical Safety evaluation and Drug Development
* 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)
* Strategic and broad technical and scientific leadership capabilities; ability to guide/support/oversee delivery of technical initiatives or new capabilities for the organization.
* Good understanding of global regulatory requirements and ability to respond to questions from Regulatory Agencies.
* Experience in matrix leadership and collaborative initiatives, strong managerial competencies.
* Excellent partnering and decision-making skills.
* Understanding and experience with the use of predictive models and data science
* Negotiate and influence decision-making processes, think and manage through issues into resolution, lead scientific discussions.
* 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.
* Ability to connect and empower people, discover and develop potential and challenge in a positive manner where necessary.
Key Working Relationships
Identify the most important working relationships with people inside and outside the company including customers, vendors, associations, etc. Briefly describe the nature of the contacts.
Discovery Medicinal Chemistry, Global Head of Developability, Global Head of Discovery Process Research, Pharm Sciences, Drug Product Development
Academic and industry research collaboration partners, 3^rd party vendors/CROs
List number of employees reporting to this position, both directly and through direct reports.
Direct Reports: None initially
Indirect Reports (oversite of key initiatives & capabilities within Developability)
Janssen Pharmaceutica N.V. (7555)
Non Operating Companies