Sr. Clinical Research Associate

Job ID: SCRA2018

Location: San Diego, California, USA


Job Description

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 a 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.

As part of our company’s commitment to developing and delivering to the market a suite of high-performance products, we have an opening for a Sr. Clinical Research Associate, on a full-time basis.  The individual in this key role will have primary responsibility for the design, set-up, maintenance, and close out of all of the company’s clinical studies and trials.  As well, s/he will work with other members of staff to manage databases of clinical trial-related information and inventories of clinical samples.  As a team member within this small but growing company, the individual will have an opportunity to make a major contribution to the successful development and commercialization of a novel technology.

 

 


Responsibilities

·        Manage all partnerships with the company’s external clinical sites, including communicating and meeting with staff at the sites on a regular and an ad hoc basis;

·        Use knowledge of clinical trial inclusion and exclusion criteria in order to design successful clinical trials and studies;

·        Coordinate logistics on sample transportation and handling;

·        Manage databases of clinical information, and partner on sample accessioning and tracking;

·        Partner with other members of the Team on managing interactions with external CROs;

·        Contribute to defining project scope, budgets, and timelines, and monitor ongoing activities to ensure that efforts are successful and within budget;

·        Ensure that projects comply with all relevant SOPs, regulations, and quality standards;

·        Report on progress and issues with clinical trials and studies on a regular and/or as-needed basis;

·        Contribute to process improvements in all areas related to clinical trials and studies; and

·        Other duties as assigned.


Skills and Qualifications

·        Bachelor’s degree or equivalent in the Health Sciences or Biological Sciences;

·        5+ years of experience managing clinical trials, at a clinical site, sponsor institution, highly desirable;

·        Direct experience with diagnostics or medical devices highly preferred;

·        Experience in handling datasets for clinical studies, with direct knowledge of databases highly preferred;

·        Knowledge of cancer biology and/or therapeutics is a plus;

·        Ability to generate reports, present within the organization, and make external presentations preferred;

·        Strong verbal and written communication skills;

·        Willingness to travel to clinical sites (20% - 25%), both locally and elsewhere in the US, as needed; and

·        Ability to exercise discretion with regard to the confidentiality of patient information, per HIPAA and other guidelines.

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 or an event. Specific vision abilities may be required by this job including close vision and ability to adjust focus.  Variable requirement for travel not to exceed 25% on a regular basis.

The successful candidate will join a dynamic, innovative team focused on developing cutting edge technologies in a fast-paced, collaborative environment. Biological Dynamics is an equal opportunity employer. We offer competitive compensation and benefits as well as a positive, diverse and exciting work environment.  To apply for this position please email your cover letter and resume to Biodyn.hr@biologicaldynamics.com.

 


To apply please send your resume and cover letter to biodyn.hr@biologicaldynamics.com.


Biological Dynamics is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Clinical Research Manager

Job ID: CRM2018

Location: San Diego, California, USA


Job Description

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 a 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.

As part of our company’s commitment to developing and delivering to the market a suite of high-performance products, we have an opening for a Clinical Research Manager, on a full-time basis.  The individual in this key role will have primary responsibility for the design, set-up, maintenance, and close out of all of the company’s clinical studies and trials.  As well, s/he will work with other members of staff to manage databases of clinical trial-related information and inventories of clinical samples.  As a team member within this small but growing company, the individual will have an opportunity to make a major contribution to the successful development and commercialization of a novel technology.  This is a great opportunity for an experienced Sr. Clinical Research Associate ready for advancement and increased responsibility and independence.

 

 


Responsibilities

·        Manage all partnerships with the company’s external clinical sites, including communicating and meeting with staff at the sites on a regular and an ad hoc basis;

·        Use knowledge of clinical trial inclusion and exclusion criteria in order to design successful clinical trials and studies;

·        Coordinate logistics on sample transportation and handling;

·        Manage databases of clinical information, and partner on sample accessioning and tracking;

·        Partner with other members of the Team on managing interactions with external CROs;

·        Contribute to defining project scope, budgets, and timelines, and monitor ongoing activities to ensure that efforts are successful and within budget;

·        Ensure that projects comply with all relevant SOPs, regulations, and quality standards;

·        Report on progress and issues with clinical trials and studies on a regular and/or as-needed basis;

·        Contribute to process improvements in all areas related to clinical trials and studies; and

·        Other duties as assigned.


Skills and Qualifications

·        Bachelor’s degree or equivalent in the Health Sciences or Biological Sciences;

·        2 to 5 years of experience managing clinical trials, at a clinical site, sponsor institution or CRO, highly desirable;

·        Direct experience with IVDs or medical devices highly preferred;

·        Experience in handling datasets for clinical studies, with direct knowledge of databases highly preferred;

·        Knowledge of cancer biology and/or therapeutics is a plus;

·        Ability to generate reports, present within the organization, and make external presentations preferred;

·        Strong verbal and written communication skills;

·        Willingness to travel to clinical sites, both locally and elsewhere in the US, as needed; and

·        Ability to exercise discretion with regard to the confidentiality of patient information, per HIPAA and other guidelines.

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 or an event. Specific vision abilities may be required by this job including close vision and ability to adjust focus.  Variable requirement for travel not to exceed 25% on a regular basis.

The successful candidate will join a dynamic, innovative team focused on developing cutting edge technologies in a fast-paced, collaborative environment. Biological Dynamics is an equal opportunity employer. We offer competitive compensation and benefits as well as a positive, diverse and exciting work environment.  To apply for this position please email your cover letter and resume to Biodyn.hr@biologicaldynamics.com.

 


To apply please send your resume and cover letter to biodyn.hr@biologicaldynamics.com.


Biological Dynamics is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Head of Clinical Affairs

Job ID: HCA2018

Location: San Diego, California, USA


Job Description

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.


Responsibilities

  • 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.

Marketing Manager - Oncology Diagnostics

Job ID: MM2018

Location: San Diego, California, USA


Job Description

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 a 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 Marketing Manager to manage the development and execution of clinical marketing and commercialization initiatives in our Oncology segment. As a member of our dynamic Commercial Operations team, you will be working on multiple fast-moving initiatives in the evolving space of Oncology Diagnostics. This is a unique opportunity to be a key contributor in bringing to market cutting-edge diagnostic solutions for Oncology. The most successful candidate for this Marketing Manager role will be a fast learner who is highly collaborative and possesses sound judgment and exceptional time management skills.  The ideal candidate must be comfortable with, and thrive in, an entrepreneurial environment which necessitates a hands-on approach at all levels.


Responsibilities

·        Contribute to the development and execution of the product launch strategy, as well as the long-term market and product strategy for the Oncology segment;

·        Write copy for marketing materials, collaborate with the internal team and external agencies to develop marketing content (campaigns, positioning, messaging, etc.) and collateral.  Interface with Product Development, Quality, Clinical and other teams to ensure strategic alignment and coordination of initiatives;

·        Contribute to, and update over time, the relevant chapters of the Design Control documents, including the Customer Requirements Document (CRD) and the Product Requirements Document (PRD). Training will be provided;

·        Collect and analyze market research information which includes, but is not limited to, participation in the conducting and documenting of user and customer interviews, and the planning and execution of focus group meetings with varying types of current and potential clients;

·        Perform competitive research and benchmarking, to include the identification of key thought leaders in the industry;

·        Drive, track, and forecast relevant business metrics (revenue, growth targets, etc.);

·        Coordinate and represent the company at industry events and during customer visits, conduct lead follow up, and provide regular updates to the management; and

·        Other duties as assigned.


Skills and Qualifications

·        Bachelor’s Degree in life sciences, business or medicine is required. MBA preferred;

·        Minimum of 2 years of experience in regional or global diagnostics marketing, or a Product Management role within the Clinical Diagnostics industry in Oncology;

·        Experience with the design and execution of marketing programs and launches of clinical products and/or lab-developed tests in the US Oncology segment. Experience with both US and EU markets preferred;

·        Experience with marketing to health care providers and clinical laboratories;

·        Excellent oral and written communication skills, and a demonstrated ability to learn and communicate complex medical topics;

·        Proficiency in the use of PowerPoint, Word, and Excel; comfortable with Salesforce and Google Docs; and

·        Possesses a can-do positive attitude, which is a must!


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. To apply for this position please email your cover letter and resume to BioDyn.hr@biologicaldynamics.com.


Biological Dynamics is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Executive Assistant

Job ID: EA2018

Location: San Diego, California, USA


Job Description

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 Executive Assistant to provide high-level administrative support to the leaders and team members alike, to include such activities as management of calendars, meeting planning and coordination, preparation of correspondence, documents and presentations, conducting research, handling information requests, performing advanced administrative functions and managing complex details.  The ideal candidate for this position will possesses a can-do, will-do attitude which will be critical, as is the ability to recognize a need and, without direction or encouragement, be willing to act accordingly to meet the need or resolve the issue.  S/he must also be effective at multi-tasking and maintaining a highly organized environment.  In addition, the ideal candidate must be comfortable with, and thrive in, an entrepreneurial environment which necessitates a hands-on approach at all levels.


Responsibilities

•        Exercises independent judgment in relieving the leaders and team members of administrative details;

•        Creates and maintains a well-organized and efficient office environment;

•        Manages calendars, effectively communicates changes as needed and fosters an environment of promptness and timeliness;

•        Answers and screens incoming calls with a focus on taking care of the callers’ needs in order to minimize the need for a hand off to others;

•        Greets callers and visitors in a professional manner and assists with the handling of incoming mail and packages;

•        Coordinates travel, onsite meetings and board meetings;

•        Provides timely and organized information and correspondence;

•        Develops and manages a confidential administrative and legal filing system;

•        Creates and maintains a database of key information and reports;

•        Fulfills the role of a project manager when needed to ensure the team members are on track and timely in their submission of reports, presentations and other materials;

•        Responsible for meeting planning, including coordinating of reports, agendas, board packages, media, etc.  Prepares agendas and attends meetings as requested;

•        Manages reception area which could include the efficiency of processes and procedures, and coordination of schedules to ensure a secure facility during the company’s operating hours;

•        Generates ideas that will streamline work and identifies issues that require immediate attention in the organization; and

•        Performs other tasks as requested.


Skills and Qualifications

  • Communication skills:  This position requires excellent written and verbal communication skills.  The individual must have ability to compose correspondence using proper grammar, sentence structure and spelling and must be able to effectively communicate and interact with team members at all levels;
  • Mathematical skills:  Requires basic mathematical and analytical skills;
  • Computer skills:  Requires advanced working knowledge of MS Office software and strong working knowledge of PowerPoint presentation and graphics software.  Experience with Gmail and Google docs is highly preferred;
  • Reasoning ability and other skills: Requires above-average reasoning ability and the ability to maintain confidentiality.  Requires excellent organizational skills and attention to detail.  The individual must have ability to prioritize work and shift priorities quickly and handle multiple assignments and tasks simultaneously;
  • Demonstrates traits consistent with the company culture - drive and perseverance in accomplishing goals; sense of responsibility and integrity; effectiveness as a team member; adaptability to new projects; planning and organizational skills; resourcefulness; determination and motivation to accept and complete tasks and possessing of enthusiasm for the business and his/her work.  A can-do, will-do attitude is critical as is the ability to recognize a need and, without direction or encouragement, be willing to act accordingly to meet the need or resolve the issue.

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.  To apply for this position please email your cover letter and resume to BioDyn.hr@biologicaldynamics.com.

 


Biological Dynamics is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.