Scientist - Biotech jobs in Elkhart, IN

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

We are currently seeking a Director, Clinical Project Scientist located in Warsaw, Poland. Remote based options within Poland may be considered on a case by case basis and if approved by the company. A pre-identified candidate has been identified for the position, however all applications will be considered.

The Director, Clinical Project Scientist (CPS) develops and leads goals/objectives and end to end delivery of clinical trials within the Oncology Therapeutic Area, including but not limited to designing, planning, developing, monitoring, and reporting of clinical research data. Interprets research results and evaluates the safety, marketability, and medical usefulness of drug product candidates. Responsible for the compliance of department, company and regulatory standards and procedures. This position may report to the CPS head or Clinical Leader.

Essential Functions:

• Executes clinical research strategies and contributes to the development and execution of clinical research programs
• Directs end to end delivery of clinical studies
• Defines clinical study parameters, supports deliverables, policy compliance and resource needs
• Serves as a clinical point of contact for cross functional teams and program level workstreams
• Reviews, evaluates, interprets results of clinical trial data preparation for submission and assists with interactions with regulatory health authorities
• Leads and performs medical monitoring/reporting, evaluates ongoing clinical trial data
• Manages and provides oversight on trial results
• Assists with development of clinical research protocols, study case report forms, informed consent forms
• Organizes documentation needed for data collection, analysis
• Reviews and maintains protocol specifications in alignment with standard operating procedures
• Guides and mentors less experienced team members in adherence to clinical research guidelines and safety procedures
• Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies
• Communicates detailed outcomes and results of research findings to relevant partners
• Anticipates areas of opportunity to ensure delivery of a quality database and contributes to data quality process improvements
• Presents research status at internal/external meetings, including investigator meetings and company sponsored events
• May lead one or more program or therapeutic area initiatives
• Works with high level of autonomy, providing decision accountability for project, owns escalations, and communicates effectively at all levels, including senior stakeholders

• Experience developing, presenting, and leading clinical data discussions

• Mentorship of less experienced team members and may have direct reporting/people management accountability

Principal Relationships

Contacts within the Company:

• Members of the Clinical and Cross Functional Trial teams

• Members of Oncology TA

• Cross Functional Senior Management

Contacts outside the Company:

• May act as a liaison, in partnership with Global Operations and Study Responsible Physician, between company and Investigators, Site Managers, Site staff, global clinical research staff, vendor project managers, and CROs

• Develops credible relationships with senior leaders, opinion leaders, medical directors, and key regulatory officials

Qualifications

• Minimum of a bachelor’s degree in a scientific discipline required, with advance degree (i.e., MSc, Ph.D., or Pharm D) preferred

• A minimum of 8 years of progressively responsible experience in clinical research, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.

• Significant knowledge clinical oncology research and its application to cancer drug development is important

Required Technical Knowledge or Skills:

• High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards is required.

• Successful independent ability to navigate in a matrix team environment with global cross functional teams is required.

• Fluent in written and spoken English with excellent oral and written communication skills is required.

• Working knowledge of the use of Microsoft suite of software products is required.

• Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality oncology clinical trials including protocol development, medical review, oversight of safety, study conduct, and data quality is required.

• Ability to travel approximately 25% domestic/international travel may be 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

This job posting is anticipated to close on May 9, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.