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Medical Director/Associate Medical Director
4 months ago
Title: Medical Director/Associate Medical Director
Overtime Status: Exempt
Employment Status: Full-Time
Pay Range: $175,000 to $240,000 / yearly DOE
The hiring pay range for this position is $175,000 to $240,000 per year based on skills, education, and experience relevant to this role.
Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.
At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:
Benefits:
Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:
- Medical, Dental, Vision, FSA, or HSA: Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents. Medical plans are currently provided through Premera Blue Cross.
- 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
- Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
- Paid Holidays: Inventprise offers 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.
- Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.
Job Summary
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.
Job Responsibilities:
- 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 Education, Experience and Skills:
- 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 workplans 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 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, Mental, and Environmental Requirements:
- Ability to sit and use a computer for extended periods.
- Ability to thrive in a fast-paced and dynamic environment with ambiguity.
- Strong problem-solving and decision-making skills.
- Ability to manage multiple priorities and meet deadlines.
Working Conditions:
- Remote, with on-site presence based on business needs.
- International and domestic travel 15-20%.
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.
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