Development Head, RSV, RSV Combination, and Early Vaccine Programs

About this role

ROLE SUMMARY

The primary purpose of the job is to oversee and ensure that vaccine clinical research and development program(s) are planned and implemented to meet company objectives.

The Development Head: • Applies extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical projects • Ensures successful program implementation through oversight and review of the program design including the clinical development plan or lifecycle strategy • Serves as the major driver for identifying and advancing new concepts and processes to provide innovative strategies to solve clinical issues • By leading and obtaining consensus from senior staff members, the Development Head solves highly complex and specialized problems related to clinical research programs in a highly matrixed environment • Applies technical/scientific expertise to resolve issues regarding the clinical components of documents (e.g., Investigational New Drugs, New Drug Applications/Common Technical Documents, global registration dossiers, lifecycle strategy documents, internal documents) • Provides procedural and scientific subject matter expertise to guide global trial leaders, clinical scientists and other clinical staff members

In addition to program level activities the Development Head may review compounds for potential in-licensing, including performance of due diligence reviews and provide assistance to new business development on market opportunity and target product profile.  The Development Head may also be required to design a development strategy with multiple protocols to obtain worldwide approval for a compound or group of compounds or a vaccine.

ROLE RESPONSIBILITIES

Lead the global clinical research program(s): • Provide high level oversight of the direction and planning of global clinical programs including the preparation of Clinical Development Plans • Oversee one or more Clinical Project Teams • Identify program issues and develop sound strategic solutions with clinical teams to ensure their timely resolution • Form ad hoc teams with appropriate representation to resolve various clinical/medical issues that develop during clinical development or lifecycle execution • Provides updates to Senior Vaccines Research and Development Management of status of clinical programs

Oversee global clinical research program(s): • Establish program priorities and drive key programs • Collaborate with clinical lead to determine the scientific content of the Investigator meeting and determine the best method for training site personnel • Oversee and participate in writing and/or review of key documents (e.g., briefing documents, manuscripts, submission documents) • Assure quality of program through oversight of initial program activities, during implementation and monitoring of clinical trials, and during completion of final documents for publication and regulatory submission

Administer/Oversee global clinical research program(s): • Oversee clinical lead and clinician medical monitor activities by identifying and tracking their deliverables from a program management perspective to ensure their timely completion • Hiring, training, and monitoring of personnel performance. Coach, train, and/or mentor clinician medical monitors and clinician clinical scientists to optimize their performance • Provide input into staffing and budgetary planning; departmental standard operating procedures (SOPs) and standard practice instructions, standardization activities; and project effort and prioritization analysis • Define medical research resource requirements to support each study in the clinical program(s) • Develop or oversee budget for a given product or entire therapeutic area as appropriate in conjunction with Finance • Provide input into the insource/outsource approach for the program(s)

Represent the medical research and Vaccines Research and Development point of view to other line functions: • Provide input into the publications strategy and critically review publications • Provide input into the regulatory strategy and interact with Regulatory Affairs and regulatory agencies as appropriate • Provide strategic scientific input to the global asset team • Interface with various auditing groups regarding medical findings (i.e., clinical study report [CSR]) and provide guidance in responding to questions

Function As Global Medical Monitor

Accountable for safety across the study: • Review serious adverse events (SAEs) and determine if a follow up action is needed • Interact with Data Monitoring Committee (DMC) and other steering/review committees as required • Answer safety questions and review the literature as needed to answer these questions or those posed by Safety Review Team, DMC, etc. • Review Informed Consent Documents from sites and where there are deviations from approved Safety Review Team wording • Safety communications to sites across the study

Provide program team(s) with medical expertise during key activities: • Issue resolution • Audit response • Study closeout/inspection readiness

Interact with regulatory groups and internal auditing groups on a project level: • Data Monitoring Committee Interaction • High level accountability for providing a response to regulatory agency inspection observations and internal audits

Contribute to, review, and edit, CSRs: • Approve patient narratives

Conduct decision point preparation for senior management. Participate in (and/ or chair) the Vaccines Clinical Review Committee (VCRC).

QUALIFICATIONS

• Medical degree (M.D./D.O. or equivalent) • 10+ years of experience in the pharmaceutical industry related to clinical research programs and registration activities • End to end vaccine clinical development experience required • Possesses the ability to critically evaluate scientific/medical information; propose new concepts and innovative ideas in drug development • Understands the

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