With patients at the heart of everything we do, The Lung Cancer Initiative (LCI) at Johnson & Johnson was formed in 2018 to unleash the full potential of lung cancer science to help change the trajectory of this complex disease.
As an R&D engine, the LCI takes a multidisciplinary approach in bringing together the unparalleled expertise, technology, scale, and reach across Johnson & Johnson within its Pharmaceutical, Medical Device, and Consumer Health sectors, and works with collaborators worldwide to advance innovations that aim to create more effective and personalized treatments for lung cancer and other selected solid tumors with the goal to improve patient outcomes.
This position is responsible to lead all the early development oncology pharmaceutical clinical projects, as well provide oncology development experience to the in clinic medical device portfolio used in the treatment of cancer. Specifically, this individual will be responsible for the development and execution of the clinical portion of the LCI pharmaceutical strategy, which is focused on intratumoral therapy designed to treat lung cancer and selected other tumor types across the continuum of disease with a goal of treating earlier forms of the disease and a long-term goal of preventing lung cancer. In addition, the incumbent would provide oncology clinical expertise to the medical device sector in the design & conduct of clinical trials in support of both robotic and non-robotic devices used in the care of solid tumors.
This position is responsible for the design and execution of the early phase clinical trials from first in human to proof of concept and beyond. This will include responsibility for the overall development strategy as well as individual trial design working closely with the discovery and biomarker teams. Key elements of success for this effort will include developing both a short term and long term clinical strategies that acknowledges the existing capabilities and resources that exist within the Johnson & Johnson family of companies, while laying out a vision that is integrated with the overall Lung Cancer Initiative and New Venture strategy. On the medical device side, this position will provide critical oncology drug development experience on areas of endpoints, trial design and conduct to meet evolving regulatory standards for novel medical devices used in the treatment of solid tumors, in particular lung cancer.
Major Responsibilities Include:
- Develop and continuously refine the lung cancer & other solid tumor clinical strategy as well as clinical development plans for pharmaceutical assets at the time of LLO through NME and into the clinic. Meet with key internal (e.g. LCI Management Team, Janssen Oncology) and external (e.g. KOLs, health Authorities) stakeholders to receive input and drive alignment, under the guidance of the Head of Clinical Development & Medical Affairs
- Oversee the execution of the LCI Clinical portfolio to deliver against the LCI strategy, both in terms of scientific and commercial expectations. Partner with clinical operations team both within LCI and within the GCDO organization in Janssen to deliver on timelines and budget for all clinical trials
- Will be responsible to attract & retain talent for the clinical organization as it continues to grow. This will include tumor specific expertise both at physician and clinical scientist level, and across specialties (e.g. radiation oncology, urology, radiology, thoracic surgery. This position will also require managing direct reports responsible for the individual programs
- In conjunction with senior management, will be a key LCI spokesman to help shape the overall LCI efforts both internally and externally. This may require presentations to internal J&J governance teams such as First in Human Committee, Development Committees as well as additional J&J Internal stakeholders as needed.
- Partner with key internal stakeholders to provide clinical input into the business development strategy. This will include supporting landscaping efforts as well as the evaluation of external assets and development of CDPs in support of licensing. This will be done in close partnership with the Pharmaceutical Sciences Leader, Business Development, Innovation centers and JJDC.
- Attend key Scientific Meetings to either present data or to work directly with external experts. Author or edit key scientific (and patent) publications highlighting critical findings from clinical research.
- MD or equivalent medical degree
- Fellowship trained in oncology
- Comprehensive knowledge and experience in early and/or late stage drug development.
- Have minimum of 12 years’ experience in either academics or in biopharma in clinical research
- Have operated in a matrix environment and have worked across a complex organization.
- Outstanding communication skills, able to influence and guide without arrogance or ego across multiple functions.
- Have successfully hired, managed and developed a team.
- To be successful in this role will require deep early and late-stage clinical experience and understanding, across oncology and pulmonology specifically, and an ability to shape clinical strategies with an understanding of the patient, regulatory bodies, competitive landscape and internal capabilities sufficient to ensure optimum solutions.
- Fluent in written and spoken English.
- Working knowledge of the use of Microsoft suite of software products including Excel, PowerPoint and Word.
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.
- Demonstrate and inspire the behaviors that reinforce Our Credo.
- Serve as a role model for making Credo-based decisions
- Create a trusting, collaborative, and ethical work environment
- Maintain the highest standards of quality, compliance and accountability
- Champion programs and initiatives that support our environment and communities
The anticipated base pay range for this position is $213,000 to $368,000.
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.