We are seeking a strategic, hands-on, and problem-solving individual with prior industry knowledge to lead clinical programs for our client. that will support the company's global regulatory strategy and post approval medical evidence requirements. The Senior Director of Clinical Affairs will play a key role in the future success of the company and will be a highly visible individual, both inside and outside of the organization in developing physician networks and communicating to regulators. This individual will be critical to furthering the company's mission and deep commitment to developing and commercializing innovative hemoadsorptive therapies that address critical care needs.
location: Monmouth Junction, New Jersey
job type: Permanent
salary: $230,000 - 250,000 per year
work hours: 9 to 5
- Responsible for the design and reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for the development of products from Phase 1 to approval.
- Actively participate in a teamwork environment across all functional disciplines. Work collaboratively with Project Management and the Project Team (including Quality, Regulatory, R&D, CMC, Epidemiology, Biostatistics, Finance and Business Development).
- To design, and provide clinical oversight of company-sponsored clinical trials in the U.S. and abroad:
- Development of trial protocol and other related documents.
- Support interactions with regulatory agencies (e.g. FDA), advisory boards, DSMB.
- Support safety reviews of protocol benefit to risk assessment, protocol adverse event reporting, responses to regulatory questions and ethics committees and oversight.
- Collaboration with external and internal functional stakeholders for the design, conduct, analysis and communication of clinical studies including (but not limited to): clinical operations, biostatistics, preclinical biology, epidemiology, Access and Reimbursement, etc.
- In conjunction with Clinical Operations is responsible for monitoring of clinical trial quality and conduct.
- Under the direction of the CMO to author clinical trial reports and scientific journal articles.
- An M.D. or M.D./Ph.D. or equivalent degree and a minimum of 3-5 years of experience in biopharmaceutical or device development roles.
- Experience in the therapeutic areas cardiopulmonary disease or acute care highly desired with description of contribution in specific areas of development (e.g., early and late clinical, translational, product launch, and post-marketing)
- Understanding of either drug development or experience with device development strongly preferred
- Demonstrated track record of successfully supporting, developing and executing clinical development plans
- Prior regulatory experience with IDE or NDA submissions, preparation of regulatory documents and presentation to FDA or other regulatory authorities desired but not required
- Proven ability to strategize prioritize and manage multiple projects simultaneously to ensure quality, timely, on-target accomplishment of tasks
- Ability to embed medical functional skills and strategic thinking in to teams
- Ability to discriminate between critical and non-critical activities and to develop or improve processes
- An ability to collaborate and communicate effectively internally and externally and to collaborate effectively with internal and external partners including the ability to work in matrixed environments including both company staff and consultants.
skills: NDA, Clinical research
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.