Clinical Development Director Vaccines

Job Title: Clinical Development Director Vaccines

Job Number: 69614

Location: , US

Job Description

* Development and ownership of the clinical development plan. * Acting as a clinical expert liaison and manager. * Designing clinical trials. * If medically qualified, providing medical monitoring for company-sponsored clinical trials. * Analyzing clinical data. * Communicating project information and plans both internally and externally. * Contributing to regulatory submissions, as well as publications and presentations in the relevant field. * Formulating, revising, and efficiently executing the clinical development strategy.Reporting directly to the VP of Vaccines Clinical Development, the (Associate/Senior) Clinical Development Director (CDD) holds responsibility for supporting (in the case of an Associate or Director) or leading (in the case of a Senior CDD) the strategic planning and day-to-day management of the designated clinical program(s), considering the entire clinical development perspective. In the capacity of (Associate/Director/Senior) CDD, you will oversee the clinical development of the assigned clinical study/studies and guide the implementation of the clinical development plan. Furthermore, you will foster an empowered organization capable of operating effectively within a matrix environment and adapting swiftly to evolving business needs.

Responsibilities

Providing clinical guidance and strategic input for all clinical-related tasks within the assigned project or segment of a clinical program. These tasks encompass various clinical responsibilities such as crafting clinical sections within individual protocols or sub-studies, aligning them with Integrated Development Plans (IDP), reviewing clinical data, establishing program-specific standards, preparing clinical components of regulatory documents and registration dossiers, and participating in the publication process. Taking the lead in developing clinical sections of regulatory documents at both trial and program levels. Driving the implementation of the clinical program in collaboration with Clinical Operations, Program Management, Bioanalytical, Biometrics, Regulatory, Clinical Trial Supply functions, and outsourced Development functions, including Clinical Research Organizations. Supervising and conducting ongoing medical and scientific assessments of clinical trial data in conjunction with Clinical Scientific Experts, under appropriate supervision from the Medical Lead. This includes ensuring the data’s interpretability (assessment of safety and efficacy), reportability (identification of emerging issues), and accuracy. Contributing to initiatives led by Clinical Operations and Project Management to ensure compliance with Good Clinical Practice (GCP) for clinical trials, overseeing clinical research organizations, and managing the development and monitoring of trial-related budgets. Supporting Pharmacovigilance in upholding the overall safety of the vaccine and potentially serving as a core member of the Safety Management Team, aiding in the comprehensive reporting of program safety. Acting as a clinical expert and assisting the VP Clinical Development and Chief Development Officer in their interactions with both external and internal stakeholders and decision-making boards. Playing a role in educating relevant stakeholders about the disease area and vaccine through scientific training efforts and potentially serving as a speaker for medical and scientific training within the franchise.

Required Skills

An advanced degree in life sciences or healthcare (or a relevant clinical degree) is mandatory. The minimum years of experience required in clinical research or drug development will vary depending on the position level, with Associate Clinical Development Directors needing 2 years, Clinical Development Directors needing 3 years, and Senior Clinical Development Directors needing 5 years of experience. It is desirable for candidates to have a working knowledge of vaccines and a demonstrated ability to understand, discuss, and present efficacy and safety data related to clinical trials or program-level activities. Candidates must have proven skills in establishing effective working relationships with key investigators, and they should possess knowledge of Good Clinical Practice (GCP), clinical trial design, statistics, as well as regulatory and clinical development processes. Strong communication abilities are essential, particularly for collaborating within a cross-functional and global organization. Experience in contributing to Investigational New Drug (IND) or Biologics License Application (BLA) submissions is a plus. Salary range: $198,000-230,000K annually Benefits: Health Insurance (medical, dental, vision) Life Insurance Short- and Long-Term Disability 401(k) Paid Time Off

Application Deadline: 2023-12-25