Serves as the lead for Vaccine development strategy and execution of clinical trials. This role will be responsible for designing and executing clinical studies, helping to build the clinical development plan and execute the plan for new vaccine assets.
Provides input on local risk management activities and medical oversight of all clinical trial related activities, adhering to GCP/GMP standards & quality.
Connect with both internal and external scientific leaders and key stakeholders. Function as key leader on all vaccine-related business development
- Execute, the design and conduct of Company’s vaccine assets, responsible for the design and medical monitoring (MD) of clinical studies. Create, develop, and implement a successful strategy for our vaccine portfolio that will bring forth programs to successful approval and registration.
- Ensure that clinical programs and clinical studies are designed and monitored optimally. Ensure that clinical documents (Protocols, CSRs, Background Documents) are of the highest quality. Implement clinical R&D policies, SOPs, and related directives
- As the primary expert for assigned studies, be the first point of contact internally and externally for questions regarding the study (e.g., eligibility, enrollment; safety and patient management). Monitor study progress to ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from the cross functional team. Take a key role in the authoring of critical study documents (e.g., CSR, IB, protocol synopsis).
- Contribute to the analysis and interpretation of data generated internally or externally and present study updates, interim results, and final headline data to senior management as required
- Contribute to the cross functional development of clinical development plans (CDPs) that integrate pre-clinical, early clinical findings and data sciences approaches – working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development.
- Identify and engage with external Key Opinion Leaders to address scientific and medical questions relevant to the program.
Education and Experience:
- MD, MD / Ph.D. or Ph.D.
- 4+ years’ industry clinical development experience, preferably in vaccine development including 3+ years’ experience leading cross-functional development teams and management experience
- Demonstrated excellence and experience in late-stage clinical development for vaccines, including the design, execution, and reporting of pivotal trials and NDA/BLA/MAA filing experience
- Experience in leading medical and scientific aspects of clinical studies on cross functions teams
- Ability to critically review, analyze and interpret key aspects of clinical study conduct, including research design, methods, outcome measures, is required.
- Phase 1 clinical study experience desirable
- Effective communication skills to enable engaging and influencing diverse stake holders
- Ability to navigate complexity and make risk-based decisions
- Self-starter who can independently lead assigned projects
- Demonstrated ability to engage and influence diverse stakeholders from a variety of professional backgrounds
Competencies and Attributes:
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s culture and values – courageous, imaginative, selfless, and joyful
The anticipated annual salary range for this role at Director job level is $220,000 – $285,000. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. The final salary offered to a successful candidate will be dependent on several factors that may include – but are not limited to – the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.
The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.
Health & Wellness Benefits, 401(k) and PTO Overview:
- All Company employees (and their families) are covered by medical, dental, and vision insurance, with Company paying ~90% of plan premiums.
- Company pays the full premium for basic life and disability insurance for all employees.
- Company employees are also eligible to enroll in our Company’s 401(k) plan and are always 100% vested in their account balances. The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.
- New Company employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays.