COMPANY BACKGROUND & CULTURE
Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.
Who is Janssen?
We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives.
Our Mission and Vision:
Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So, every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate, but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
Within Discovery, Product Development & Supply, the Small Molecule Drug Product Development organization has an open position for a Senior Scientific Director.
The job holder has accountability for the senior scientific leadership for Drug Product Development (DPD) within Small Molecule Pharmaceutical Development, Janssen R&D, assuring scientific excellence. This encompasses all formulation and process development aspects of the entire small molecule development portfolio from late discovery until commercialization across all drug product technology platforms in oral solid, liquid and parenteral dosage forms, covering multiple internal-external sites globally (North-America, Europe, Asia).
The job holder provides strategic guidance to the DPD organization. As senior scientific leader, he/she is accountable for scientific-technical coaching and in-depth reviews with respect to all pharmaceutical development related aspects across the entire small molecule drug product portfolio. As needed, he/she is responsible for internal escalations and participates in cross-functional governance bodies within Small Molecule Pharmaceutical Development (SMPD) and beyond. To achieve these business-critical objectives, the senior scientific leader will as needed closely partner and fully align with key stakeholders within e.g. SMPD, Clinical Supply Chain, Janssen Supply Chain, QA, Regulatory Affairs, Clinical Pharmacology, Discovery Sciences, Nonclinical Safety, Therapeutic Areas and/or the Global Commercial Strategy Organization.
Related to the goal to establish best processes at launch, the job holder will be responsible and accountable for co-defining and implementing the evolving end-to-end process development and engineering strategy and improvements within pharmaceutical development, also including associated disciplines such as PAT, modelling, data sciences. Further, he/she will manage the DPD risk register across the entire portfolio.
Across DPD, the job holder will be accountable for identifying and installing (alternative) funding mechanisms and innovation budgets – both internally as well as externally – and partnering with external (academic) networks. Further he/she will introduce and/or strengthen new and innovative technologies and practices in pharmaceutical development, as required by e.g. DPD, SMPD and Janssen R&D in terms of drug delivery strategies and novel modalities. In view of existing and emerging drug delivery needs, the senior scientific leader will ensure thorough scouting and rapid access to know-how and innovation, enabling technologies and lab capabilities across various internal/external sites, partners, companies and (academic) institutes.
Together with the DPD Leadership Team, the job holder will have overall responsibility for the optimization of the pharmaceutical development footprint, including establishing, strengthening and properly maintaining strategic partnerships and other CROs/CMOs in the global DPD and SMPD network (Europe, Asia and North-America).
Depending on the portfolio needs, the job holder will be end-accountable for critical L&A and deep-dive activities, troubleshooting, investigations and/or related development projects.
The senior scientific leader will as needed directly interact with health authorities and external experts/consultants/partners, as required by the Therapeutic Areas and JSC portfolio, and lead cross-functional drug product oriented (external) scientific advice meetings.
The job holder will have a proven ability to lead, manage and develop high functioning and diverse teams in a global context. The job holder will have scientific-technical expertise and significant drug product experience gained through developing and filing numerous Small Molecule compounds, next to a proven track record in strategic improvements and impact. He/she demonstrates excellent professional skills in terms of (1) strategic thinking and the ability to help define a vision for the future, (2) communication and stakeholder management, (3) influencing and impacting others, both within Drug Product Development and externally with other CMC, R&D or JSC departments worldwide.
The position will report to the Global Head of Small Molecule Drug Product Development and be part of the DPD Leadership Team.
Major Duties & Responsibilities
Approximate Percentage of Time
Direct involvement in portfolio projects: (1) functional, deep-dive reviews and coaching of all project development activities within DPD; as applicable, cross-functional reviews, internally and externally; (3) external representation to health authorities, L&As and external collaborations, and general scientific community; (4) direct participation in issue resolution as needed.
Accountability/responsibility for various strategic initiatives and objectives, e.g. overall DPD strategy, drug delivery and governance, funding mechanisms across DPD, global footprint optimization including strategic partnerships and outsourcing, introducing and strengthening innovative technologies, partnerships and practices in small molecule pharmaceutical development.
Stakeholder management – work with all stakeholders to ensure they are kept informed and consulted with respect to developments on projects and applicable initiatives within DPD and SMPD, with particular focus on key internal (TAs, JSC, Regulatory Affairs, Quality, Discovery Sciences, ClinPharm, GCSO, …) and external (health authorities, scientific community) partners.
Talent development, including scientific-technical and non-technical coaching and mentoring, and attracting and developing key talent to the organization.
Member of DPD Leadership Team.
Required Minimum Education:
PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering or Equivalent by experience with Masters Degree in the Relevant Area
Required Years of Related Experience:
15+ years, and 3-5 years of experience and progressively advanced duties at the Senior Scientific Director level, or the equivalent training/experience.
Required Knowledge, Skills and Abilities:
- Broad and strong scientific drug product development knowledge. Particular areas of focus are preformulation, formulation & process development for small molecules, peptides, oligonucleotides, development of (clinically relevant) control strategies, technology transfers… across a variety of drug delivery technology platforms in oral solid, liquid and parenteral dosage forms
- Experience in leading groups in a global context, strong managerial capabilities
- Demonstrated strategic thinking capabilities and the ability to help define a vision for the future
- Demonstrated drug delivery and innovation track record from late discovery until commercialization
- Strong interpersonal skills to effectively communicate with external sites and various internal and external functional areas and stakeholders
- Sound business skills, including financial acumen and business planning
- Good understanding of global regulatory requirements and ability to respond to health authority questions
- Ability to prioritize and balance compliance with business needs
- Ability to seek creative approaches to improve efficiency, reliability and productivity within Drug Product Development, by driving process/design Excellence, applied innovation, data sciences and continuous improvement initiatives
- Organizational, planning, problem solving skills and the leadership competencies needed in the completion of deliverables to the discovery and development teams
- Experience in (virtually) leading groups in a global context
- Excellent partnering and decision making skills
- Master the balance between nice-to-have and need-to-have, apply fit-for-purpose approaches to provide scientifically valid assessments
- Negotiate and influence decision-making processes, think and manage through issues into resolution, lead scientific discussions
- Make fast decisions if needed, but at the same time be inclusive and an excellent team player
- Excellent oral and written communication skills and ability to clearly and concisely present and communicate assessments and its impact to various audiences, including medicinal chemists, biologists, preclinical leaders, clinical leaders, development leaders, TA leaders… and internal management boards
- Ability to connect and empower people, coach and mentor, discover and develop people potential and challenge in a positive manner where necessary.
Janssen Pharmaceutica N.V. (7555)