Job ID: HCA2018
Location: San Diego, California, USA
Based in San Diego, CA, Biological Dynamics, Inc. (BioDyn) is a privately held molecular diagnostics company and a pioneer in the field of Alternating Current Electrokinetics (ACE)-based diagnostics. At BioDyn, we are developing novel diagnostic solutions to screen, diagnose and manage high burden conditions, such as cancer. Our diverse team shares passion for improving patient care, a focus on cutting-edge technology, and a deep commitment to innovation, which shapes the future of our company and drives our innovative culture. To learn more about BioDyn, please visit our website, www.BiologicalDynamics.com, or feel free to view a TEDx Talk given by BioDyn’s Co-founder and CEO, Dr. Raj Krishnan, at https://www.youtube.com/watch?v=wMsOYqJ4ShA.
Of immediate need to BioDyn is a full-time Head of Clinical Affairs to lead the Clinical Affairs department which will include strategic direction, planning, implementation, and management of all aspects of clinical studies. This is a hands-on role, requiring an individual who is 1.) proactively engaged in the execution of all aspects of the Company’s efforts in the clinical space, and 2.) comfortable delivering at both strategic and tactical levels to ensure the success of clinical trials and studies. In addition, our ideal candidate must be comfortable with, and thrive in, an entrepreneurial environment which necessitates a hands-on approach at all levels.
- Leads and performs all planning and execution of activities in support of clinical trials, to include: generation of study protocols and synopses, informed consent forms, CRFs, and data acquisition / management / analysis plans; interacting with Institutional Review Boards; posting of protocols; adverse event reporting; and other required documents and processes;
- Evaluates and identifies CROs to partner with; manages CRO outsourcing support, including serving as the Company’s primary contact with the CRO; and reviews reports and other documentation from CROs to ensure that the clinical studies are performed according to the highest standards of quality and adherence to protocols;
- Interacts closely with clinical study sites, in cooperation with CROs;
- Proactively and swiftly generates and implements solutions to issues or risks to the success of clinical trials;
- Partners and communicates effectively with all other groups at the Company, including Research and Development, Commercial Operations, Quality, and Regulatory Affairs;
- Maintains frequent and productive communications with internal departments / team members and external vendors / partners to ensure clear and consistent messaging to all relevant stakeholders involved in clinical trials and management;
- Optimizes internal processes for clinical research and ensures that the procedures are up to date with current and revised regulations;
- Ensures that clinical studies are optimized to support the launch of new products;
- Manages, independently and in conjunction with CROs, site selection, budgets, and resource planning for clinical studies, in accordance with established timelines and quality standards, including inspection readiness;
- Supports development of the global clinical research strategy and pursues efficient alignment;
- Ensures that sponsored clinical investigations reflect the global strategy of the Company;
- Ensures that the procedures associated with the studies are continuously updated according to current regulations;
- Provides oversight to protocols and case report forms, which will provide adequate effectiveness and safety information;
- Ensures timely completion of sponsored studies;
- Provides and/or supervises management and training on company procedures, policies, and Good Clinical Practices (GCP);
- Leads, motivates, and develops employees in the achievement of goals, growth of the organization, and creation of ideas; and
- Other duties as assigned.
Skills and Qualifications
- Advanced medical / scientific degree (PhD or MD) strongly preferred, with 5+ years of experience in Clinical Affairs and CRO management in medical devices or IVDs; expertise in oncology strongly preferred;
- First-hand experience running clinical trials required;
- Leadership experience required;
- Demonstrated understanding of regulatory requirements (both US and abroad) for clinical studies, including GCP and its application to clinical trials required;
- Direct experience soliciting and evaluating Requests for Proposals from CROs (preferred), selection of investigative sites / CROs / vendors, and management of external resources required;
- Demonstrated ability to solve complex problems and use highly developed independent judgment related to US and international regulations, guidelines, investigator interactions, and timelines;
- Ability to think critically and creatively;
- Travel to scientific and regulatory meetings as well as clinical study sites and CROs required (up to 20% of time); and
- Core Competencies:
- Ability to thrive in a fast-paced, hands-on entrepreneurial environment;
- Effective at planning, organizing, and prioritizing;
- Able to handle multiple tasks and deliver high quality results under tight timelines;
- High attention to detail and accuracy;
- Effective troubleshooting and problem-solving skills;
- Flexible and adaptable to change;
- Adept at building strong relationships and collaborating with colleagues at all levels;
- Highly collaborative, self-motivated, and team-oriented; and
- Effective communicator in both oral and written form.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual may be required to sit; use hands to touch, handle, or feel and reach with hands and arms. As well, s/he may occasionally be required to stand and/or move about the office. Specific vision abilities may be required by this job including close vision and ability to adjust focus.
The successful candidate will join a dynamic, innovative team focused on developing cutting edge technologies in a fast-paced, collaborative environment. We offer a positive, diverse and exciting work environment with competitive pay structures and benefits. Biological Dynamics is an equal opportunity employer. To apply for this position please email your cover letter and resume to BioDyn.Hr@BiologicalDynamics.com.