As a key member of the Vaccine Development team, the Senior Program Officer (SPO), Integrated Clinical Development, is accountable for strategically developing and managing a portfolio of grants and contracts in support of the creation of sound clinical and integrated vaccine development plans for internal and external projects. You will provide essential technical expertise to internal Program Strategy Teams (PSTs), Product Development Partners (PDPs) and other foundation partners with a focus on clinical vaccine development plans that are well integrated with CMC (chemistry, manufacturing, and controls) and regulatory activities and aligned with foundation goals. Partnering closely with the Deputy Director, Integrated Clinical Development, you will contribute to the continued development of the team’s strategic vision including participating in the setting of the overall strategy and goals for the group.
Areas of Responsibility:
- Negotiate, implement, and manage a complex portfolio of grants or performance-based contracts; including the review of letters of inquiry and grant proposals as well as providing clear, concise and insightful written analyses and recommendations for funding.
- Apply strategic and technical/scientific expertise to lead integrated clinical development plans for vaccine development in support of rapid response vaccine platforms and the acceleration of vaccine development coupled with improvement vaccine coverage supporting diseases with epidemic/pandemic potential.
- Partner closely with team leadership, including the Director, DD Integrated Clinical Vaccines Development, DD CMC Vaccine Development and DD Vaccine Regulatory, to shape and execute the overall Vaccine Development strategy.
- Consult, provide technical expertise and thought partnership, and support to grantees and other partners to maximize the impact of projects and the creation of well-integrated vaccine clinical development plans, clinical study designs, statistical analysis plans, and clinical assays for vaccine clinical studies. Review, advise, and help shape clinical vaccine development grants.
- Serve as an advisor on clinical vaccine study design; including the review of protocols, analysis plans, and clinical sections of regulatory dossiers.
- Work closely with the Discovery and Translational Sciences (D&TS) team on pre-clinical and early clinical pipeline to support and ensure smooth transitions of vaccines into full clinical development.
- Provide technical guidance and support on the foundation process for Integrated Product Development Plans (IPDPs) and the development process including definition of critical milestones and stage gates. Lead product development process as defined by the foundation for our internal and external partners.
- Support cross-cutting initiatives/sub-initiatives to accelerate vaccine clinical development in collaboration with D&TS and the Global Clinical Trial Consortium (e.g. centralization of clinical assays; pre-identification of extensive phase I and phase III clinical trial centers).
- Support the evaluation of new vaccine technologies; providing input on potential clinical development pathway.
- Represent the foundation and program to the external world as relates to position responsibilities:
- Forge collaborations with key global experts in clinical vaccine development. Work with external advisors to maintain cutting edge approaches to clinical vaccine development.
- Speak and participate in public events, forums and meetings. Serve on boards and working groups.
- Represent foundation interests in developing networks for the program.
- Support internal and external engagement partners on product development activities related to epidemic preparedness
Educational Background:
PhD and/or MD with specialization in infectious diseases and/or clinical immunology coupled with 10-15+ years of industry experience.
Skills/Experience:
We are looking for people who enjoy the opportunity of working on complex projects and collaboratively creating solutions that have the potential for transformational change. We seek a vaccine clinical development professional with an extensive understanding of the ways clinical development integrates with CMC and regulatory development. The following experience is particularly desired:
- Deep expertise in infectious diseases and/or clinical immunology; with an emphasis on knowledge of epidemic infectious diseases coupled with a minimum of seven years of industry experience working with different vaccine platforms and across a range of disease areas, or,
- Experience working on cross-functional product development plans in a role requiring creative problem solving (e.g. working closely with partners and regulators to design trials and decide appropriate safety and efficacy endpoints for novel technologies where no precedent exists.).
Education and Experience
You should have:
- Extensive knowledge of clinical vaccine research from phase 1 through phase 4 including excellent statistical knowledge.
- Significant knowledge of vaccines including major challenges to development.
- Demonstrated ability to learn new disease areas and new vaccine technologies quickly.
- An understanding of regulatory requirements necessary for the various phases of vaccine development and experience interacting with regulators in all geographic regions.
- Experience with business and technical due diligence assessments of potential investments. Ability to synthesize technical and commercial information toward strategic decision making.
- Demonstrated ability to lead and affect data-driven strategy planning and implementation.
- Demonstrated experience with team management; including experience developing cross-functional and diverse (e.g. culturally and professionally) teams.
- Intellectual quickness, curiosity, discipline, resourcefulness and resilience.
- Strong judgment with a demonstrated ability to handle complex issues, multiple tasks, confidential information, and competing priorities with skill, discretion, a strong attention to detail, flexibility and diplomacy.
- Excellent interpersonal and diplomatic skills. You must possess excellent relationship management skills to develop trusting and productive relationships with a wide range of colleagues, dignitaries, leaders, grantees, consultants and other partners.
- Demonstrated excellence in scientific writing and data analysis, written and oral communication skills, and experience advocating and communicating with a broad and diverse audience.
- Understanding of how to navigate and operate within a complex, matrixed environment.
- Ability to travel up to 30% domestically and internationally.
- A sense of humor.
- Demonstrated passion for the Foundation’s values with a commitment to deliver results against our mission.
Job Function:
Organization Info
Listing Stats
Post Date:
Jan 23 2018
Active Until:
Feb 24 2018
Hiring Organization:
Bill and Melinda Gates Foundation
industry:
Nonprofit