At J&J, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. The Lung Cancer Initiative (LCI), which is a cross-sector initiative, is charged by the Executive Committee of J&J with meaningfully altering the course of lung cancer and improving survival by preventing, intercepting, and curing lung cancer.
The Johnson & Johnson Lung Cancer Initiative (LCI) is recruiting for a Sr. Director of Quantitative Sciences. The incumbent will provide statistical direction to all LCI clinical programs, including development of analytic strategy of planned and ongoing clinical trials and observational studies of pharmaceutical, medical device and/or consumer products/solutions. Responsibilities include participating in the design of clinical programs and protocols, development of interim analysis, statistical analysis plans, oversee analysis execution and reporting and as well as development of relationships with internal and external partners, as well as interactions with global regulatory agencies.
ESSENTIAL FUNCTIONS: (CORE Responsibilities)
1. Participate in the design and approval of clinical programs and protocols to meet stated objectives. This includes working with LCI clinical, regulatory, Real World Evidence functions as well as sector partners to create efficient development strategies to meet study objectives. Specific emphasis will be placed on trial design considerations including use of adaptive trial designs including Bayesian approaches, PK/PD modeling (Pharm), randomization methods, sample size estimation, creation of external or historical control groups, use of interim analysis, development of decision rules and SAPs, study result analysis and reporting.
2. As a quantitative strategic leader, identifies opportunities, fosters and drives full integration of modern aspects of research & development, including model-informed drug development (Pharm assets) and statistical methodologies, into LCI strategies and milestones.
3. Prepares and delivers advanced decision-making support to senior management using modern synthesis techniques. Identifies and promotes risk-mitigation combining quantitative sciences and disease area/competitive landscape knowledge.
4. Develops and maintains collaborative relationships with individuals and groups within the organization for purposes of analytic strategy development and execution. This includes primarily the Oncology therapeutic area at Janssen, clinical pharmacology and modeling groups, and the statistical teams within the Medical Devices (e.g. Auris Health, Ethicon and NeuWave), and Consumer sector..
5. Oversee the preparation of statistical portions of regulatory documents including IDEs, INDs, briefing books, BLAs/PMAs and other regulatory submissions.
6. Participate in strategic direction setting for LCI by presentations at LCI Core Team meetings, pillar meetings, scientific forum and in evaluating new business opportunities.
7. Represent LCI at presentations to senior management including Development Committees, First in Human Committee as well as GOC, Executive Committee, corporate partners, Global regulatory agencies and the public at scientific meetings.
- Minimum 8 years relevant experience if PhD or 12 years if Master’s is required
- Experience in early and late stage clinical development required.
- Ability to successfully work in a matrixed environment and with both internal and external stakeholders and KOLs required
- Demonstrated ability to present scientific content to diverse audiences required
- Learning agility and ability to works across multiple sectors (pharm, medical device, and or consumer) required
- Proficiency in SAS or R programming highly desirable
- Medical devices and biopharmaceutical experience highly desirable
- Comprehensive understanding of regulatory guidance documents highly desirable
- Previous experience in people leadership preferred
- This role can be located in either Spring House or Horsham, PA; Boston, MA; Raritan, Somerville, Titusville or New Brunswick, NJ with up to 20% US and International travel. Are you willing and able to meet this requirement?
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-
North America-United States-Massachusetts-Boston, North America-United States-Pennsylvania-Horsham, United States-New Jersey-New Brunswick, United States-New Jersey-Somerville, United States-New Jersey-Titusville
Janssen Research & Development, LLC (6084)