Marketing Manager

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;
  • Other duties as assigned.

 


Skills and Qualifications

  • Bachelor’s Degree in life sciences, business or medicine is required. MBA preferred;
  • Minimum of 5 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;
  • Expert 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.  Biological Dynamics is an equal opportunity employer. To apply for this position please email your cover letter and resume to BioDyn.Hr@BiologicalDynamics.com.

Chief Financial Officer

Job ID: CFO2018

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 Chief Financial Officer to help lead the company through the next phase of its growth and development.  The CFO is responsible for defining, leading and managing the financial and accounting policies, systems and processes, tax and regulatory requirements and payroll systems, processes and controls.  The incumbent will also be responsible for executive level strategic planning, financial modeling and annual business planning and budgeting.  As a member of the Executive team, she/he will provide leadership and direction to the department, company, CEO and Board of Directors. 


Responsibilities

Strategy & Executive Leadership

  • Develop tools and systems to provide financial and operational information to the CEO and make recommendations on both strategy and operations.
  • Lead long-term budgetary planning and costs management in alignment with company strategic plans.
  •  Assume the role of Corporate Secretary for the Board of Directors.
  • Participate on the board Finance and Audit committees.
  • Participate in identifying and securing external funding and funding sources, participate in fundraising meetings with potential investors.
  • Perform financial analysis of proposed collaborations, merger and acquisition and business development deals with external organizations.
  • Ensure legal and regulatory compliance regarding all financial functions.
  • Make recommendations and implement accounting/financial ERP systems as necessary.

Financial Planning & Analysis

  • Assess organizational performance against both the annual budget, periodic forecast updates and the company’s long-term strategy.
  • Establish yearly financial objectives and targets.
  • Select and engage outside consultants for the purposes of audit and investment guidance.

 Accounting

  • Establish and maintain the organization's accounting principles, practices, and procedures; ensure development and maintenance of appropriate internal controls and financial procedures.
  •  Hands-on responsibility for day-to-day accounting operations, financial statement preparation and reporting.
  • Establish and manage the day-to-day relationship with banks as well as managing existing and future debt and compliance with debt reporting requirements and covenants, if any.  Lead discussions with current and potential lenders; make recommendations related to relationships with financial partners.
  • Oversee weekly cash management, approve weekly payables and check signing.
  • Coordinate audits and proper filing of tax returns.

Other

  • Manage the Stock Option Plan in coordination with outside counsel.
  • Work with outside brokers to obtain required business insurance and identify new insurance needs and changing levels of coverage for current insurance.

 


Skills and Qualifications

  • Bachelor’s degree is required in a business or finance discipline; an advanced degree (e.g., MBA, MS) or certification (e.g., CPA, CFA) is preferred.
  • 15 or more years of relevant work experience with a minimum of 10 years in a leadership role, preferred.
  • Experience in diagnostics, medical devices or biotechnology industries preferred.
  • CFO experience in a public company and or IPO preferred.
  • 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.
  • Effective communicator across all levels of the organization, with the Board of Directors and external stakeholders 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.

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.

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.