The Global Medical Affairs role for the Lyme Disease Vaccine, reporting to the Global Medical Affairs Lead, is responsible for designing and executing the medical strategies leading to the licensure and introduction of the Pfizer Lyme Disease vaccine. This includes developing the evidence generation strategy, engaging external stakeholders, and collaborating with VRD and BU cross-functional teams to optimize medical benefit and support vaccine recommendations globally.
The Global Medical Affairs role for the Lyme Disease vaccine is the lead for engaging the worldwide medical community to identify the unmet medical need for Lyme disease. He/she will manage relationships and actively build networks with key opinion leaders in the infectious diseases and vaccinology field, Vaccine Technical Committees (VTCs), healthcare policy makers, and payers, to obtain strategic input and establish research partnerships. He/she will develop a multi-disciplinary research agenda that clearly defines the burden Lyme disease, target age groups, risk factors, and outcomes and includes vaccine effectiveness and other post-licensure evaluations. He/she will develop vaccine target product profiles with cross-functional partners, provide input on the clinical program needed to obtain recommendations / reimbursement, and contribute to the regulatory strategy to optimize vaccine label. He/she will collaborate with commercial and market access teams to develop appropriate, scientifically accurate marketing and access strategies, and propose medical tactics to support these activities.
This is a dynamic role that requires a firm understanding of the epidemiology of infectious diseases, vaccine preclinical and clinical development, as well as the ability to objectively interpret technical and commercial information in order to optimize clinical development as well as lifecycle strategies. Leadership for local licensing and VTC recommendations are also needed. ROLE RESPONSIBILITIES
- Works closely with worldwide research and development (WRD) to identify the unmet medical need for Lyme disease vaccine and develops a cross-functional multi-disciplinary research agenda including epidemiology, clinical trials, outcomes research, policy, and implementation operationalized by clinical affairs/development operations/statistics/HEOR and subject matter experts
- Ensures clear cross-functional goals are established & agreed to.
- Operationalizes various evidence generation activities including exploration of research collaborations, independent research support, preparing study data for medical queries, analysis and interpretation of data.
- Acts as key point of accountability for all scientific inquiries and communications regarding the Lyme disease vaccine program.
- Works closely with the Scientific Affairs colleagues for the Lyme disease vaccine to develop a holistic medical affairs plan where all the evidence generating activities are fully integrated and operationalized.
- Primary responsibility to review all regulatory documents for the Lyme disease vaccine.
- Defines overarching strategic portfolio opportunities and objectives for near, mid, and long term for the Lyme disease vaccine
- Ensures strategic alignment between business units (BU) and WRD in defining product concepts, supports POM/POC development paths and participates in Program Strategic Groups for early candidates.
- Provides medical input to clinical trial and safety study protocols.
- Is responsible for proactively keeping up to date and informing the Vaccines BU team of new clinical/scientific activities by competitors (e.g. new, relevant clinical trials disclosed in the public domain, emerging data, etc.).
- Creates the publication strategy/implementation for the Lyme disease vaccine in partnership with internal and external research groups.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- PhD or ScD with 6 years experience; vaccine experience is essential
- Able to influence and succeed through others. Able to form excellent relationships with key stakeholders in BU and WRD.
- Demonstrated ability in the design, initiation, and reporting of clinical studies as part of an integrated clinical plan.
- Able to review, evaluate, interpret, and present complex data; understand the emerging safety and efficacy profile of the vaccine candidate including providing a perspective with comparator vaccines.
- Excellent verbal and written communication skills including scientific writing skills and strong interpersonal skills.
- Strong work ethic and proven track record of delivering high quality within timelines.
- Entrepreneurial and motivated to challenge dogma and the status quo.
- Innovative in identifying new opportunities and finding new ways to create value.
. PREFERRED QUALIFICATIONS
Other Job Details:
- Networking - Credibility and approachability to establish and maintain important partnerships across RUs, BUs, and partner lines.
- Accountability - for self and others - Takes personal accountability for outcomes and holds other accountable for their commitments.
- Grows Others - Actively coaches and develops others. Provides opportunities and experiences to develop skills and competencies.
- Leads Through Change, Builds Change - Develops self and others in a way that enables a flexible and adaptable response to change. Demonstrates support for organizational and process changes.
- Teamwork - must be a strong team player.
- Self-Awareness - Recognizes own strengths and limitations and personal motivations. Actively seeks feedback and knows one's impact on others. Acts with authenticity and maturity.
- Insight, Influence & Inclusion - Understands other peoples' unspoken as well as explicit concerns. Adapts own approach and behavior to be more effective and inclusive and to have positive impact on others.
Last Date to Apply for Job: September 26th, 2022
Additional Location Information: US - Remote, Europe - Remote
Eligible for Relocation Package: No
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.