Medical Director/Associate Medical Director

About Inventprise

At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives—no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large-scale to Low and Middle Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We’re proud to have some of the world’s most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.

What the Role Offers - Medical Director/Associate Medical Director

Inventprise seeks to hire a(n) Associate Medical Director/Medical Director Clinical Development who will report to the Chief Medical Officer and will be instrumental in developing vaccines to improve global health. This individual will work collaboratively with Inventprise’s scientific, manufacturing, and clinical teams to take vaccines from the early phase to global product registrations. The successful candidate’s primary responsibilities will be to provide medical expertise in the oversight planning and execution of clinical trials, medical monitoring of ongoing studies, and contribute to the interpretation of the data. S/he will take hands-on responsibility for designing and managing clinical studies to evaluate the safety immunogenicity, efficacy, and dose selection of product candidates, leading a thorough data interpretation based on deep scientific and disease biology understanding, transnational expertise, and medical knowledge, including patient safety and data integrity. The Medical Director will also help mentor and supervise clinical project managers.

The successful candidate will be highly self-motivated, productive, a quick learner, and creative. S/he will have excellent problem-solving skills as well as strong written and verbal communication skills. This position requires an independent strategic thinker motivated by performance excellence and team success, someone who can roll up their sleeves and assist where needed, working within a lean Clinical, Regulatory and Portfolio Management team, and partnering with employees at all levels of the organization. The successful candidate will be a positive and enthusiastic team player, able to work with moderate guidance and take pride in the quality and timely delivery of their work.

What You Need to Succeed

• Support the conceptualization and design, development, execution, and communication of clinical studies evaluating vaccines for a variety of global health infectious disease indications.
• Own and ensure preparation for clinical sections of key documents according to regulatory and medical standards, including Investigator's Brochures, clinical protocols, clinical study reports, summaries submitted to regulatory authorities, responses to questions from regulatory authorities, IRBs and ethics committees.
• Provide medical oversight of ongoing clinical trials including but not limited to assessment of eligibility criteria and review of adverse events.
• Act as sponsor contact for medical and participant safety issues.
• Provide scientific and clinical guidance to clinical operations staff and contract research vendors in order to meet project deliverables and timelines
• Ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
• Review and interpret safety data and ensure timely regulatory reporting as required.
• Participate in the development and review of clinical and regulatory SOPs.
• Participate in immunogenicity and safety lab vendor selection, including review of clinical assay development and validation reports
• Effectively communicate protocols and other relevant information with contract research organizations and clinical site investigators and staff
  
• Interpret clinical trial data and communicate results clearly and accurately to multiple internal and external stakeholders.
• Develop abstracts and present data at scientific congresses and participate in the development of manuscripts for publication in peer-reviewed journals.
• Represent clinical team at decision/governance meetings, senior management, or advisory boards as applicable.
• Support in-licensing and out-licensing activities and partner relationships.
  

Required Qualifications:

• M.D., or DO with clinical research experience.
• MPH and/or other advanced training in statistical methods and/or trial design desirable.
• Board certification in primary care specialty with pediatrics training preferred.
• Infectious diseases or allergy/immunology fellowship training desirable or other evidence of expertise in immunology and/or infectious diseases.
• Demonstrated leadership experience and several years (>2+ years) line management experience in matrix organization. Ability to lead horizontally and drive execution of work plans in collaboration with other functions, without having formal line management authority.
• At least 2 years experience in clinical development—academic clinical research with regulated products acceptable but experience working in pharma/biotech or contract research organization preferred and prior vaccine development experience in either academia or industry highly desirable.
• Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated in later-stage programs leading to successful registration is an advantage.
• Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies.
• Excellent scientific communication skills (both verbal and technical) and interpersonal skills.
• Ability to work independently and effectively in a fast-paced, team-based, cross-functional environment. Possesses a sense of urgency without overlooking key details; identifies challenges and problems and takes the initiative to identify solutions.
• Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings. Ability to apply situational management style to both mentor and accelerate capabilities of its reports.
• Strong personal time-management and project-management skills
• Mastery of Microsoft Word, PowerPoint, and Excel.
• Experience with GraphPad Prism, SAS, or R desirable.
  

Physical Requirements

• Frequently use of office equipment that requires manual dexterity to operate (i.e. computers, phones, etc.).
• Occasional carrying, handling, and reaching for objects up to 30 pounds.
• Frequently sit or stand for long periods of time.

Mental Requirements

• Requires operational discipline to consistently focus and execute work-related tasks, with a minimum of human error and supervision. This involves self-checking of work immediately upon completion, and the ability to find / correct errors.
• Ability to elevate potential concerns/discrepancies to supervisors or management in a timely fashion.
• Ability to manage time effectively to coordinate multiple projects simultaneously required.
• Ability to use problem-solving techniques to ensure project goals are met.
• Effective communication skills both verbal and written are necessary to communicate within different departments and with external clients, maintaining a professional demeanor.
• Ability to adhere to ethical standards of conduct as well as applicable state and federal laws.

Working Conditions:

• Remote, with on-site presence based on business needs.
  
• International and domestic travel 15-20%.
  

Estimated Base Salary: $175,000 to $240,000 / yearly DOE

Benefits:

• Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
• Paid Time Off: Generous PTO, in addition to paid holidays.
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock plans.

Our People-First Philosophy

At Inventprise, you’ll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.

Equal Opportunity Employer

Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.