The Medical Officer (MO) Team Leader is a senior MO with more than 10 years of experience conducting clinical research with a significant leadership role undertaking substantial management responsibilities and high-level expertise in the scientific and strategic design of studies and clinical development plans in support of product development. The MO Team Leader leads and supervises the work of the CVIA Clinical MOs and reports to the Clinical Global Head of CVIA Clinical.
Responsibilities
Contribute to leadership of CVIA Clinical as a member of the CVIA Clinical Management team.
Support the planning, oversight and implementation of clinical trials conducted by CVIA.
Serve as a resource decision leader for review of allocation of medical officer resources to support the clinical portfolio.
Supervise the activities of the MOs towards the fulfillment of all their functions, providing guidance, ensuring adherence to PATH policies and CVIA SOPs, maintaining timelines, addressing challenges, trouble shooting, advising on investigations and CAPAs.
Identify and address performance concerns of medical officer staff.
Ensure that the MOs are qualified by education, training and experience to support the assigned clinical trials.
Promote the job satisfaction of staff by acknowledging their contributions.
Provide opportunities for professional growth and support career development; identify training opportunities.
Provide consultation in the selection of appropriate clinical sites and investigators, clinical laboratories and Clinical Research Organizations (CROs).
Responsible for and ensures training of staff on Good Clinical Practices, human subjects protection, responsible conduct of research, local and international regulations and ethical requirements.
Review progress of all ongoing clinical trials, assess risks, anticipate issues, resolve issues related to the conduct of the trial, address conflict, interact with partners at a higher level.
Identify and advise on the resolution of safety issues and other problems that may impact trials progress or quality.
Lead work-force planning for staff under your supervision.
Actively participate in CVIA Clinical Leadership meetings to:
Discuss new areas of engagement for the team, including support to new studies.
Discuss staff assignments and identify future needs.
Discuss and decide on workforce allocations (including staff LOE).
Discuss and allocate CVIA Clinical resources (travel, training, consultantships, materials, etc.).
Convene and lead regular, periodic discussion among medical officers, addressing scientific, clinical, and administrative issues.
Identify, evaluate, and provide mitigation plans for operational risks in the implementation of clinical trials.
Ensure status and progress of clinical trial projects are current and accurate.
Responsible for the development of a comprehensive approach to coordination, harmonization, and oversight of clinical trial activities across CVIA.
Participate in ORA quarterly routine meetings.
Participate in ORA meetings related to specific discussion on study issues (non- compliance, protocol violations, and other).
Required Skills
Knowledge of world-wide pharmaceutical and regulatory requirements, including GCP, ICH, and other guidance documents and policies related to clinical trials required by FDA, EMEA, WHO and equivalent international regulations.
Extensive knowledge of clinical trial operations, regulatory requirements, procedures, and policies.
Demonstrated leadership and project/program management skills as evidenced by planning, developing, and managing complex clinical trials program.
Experience with international clinical research, preferably research carried-out in developing countries.
Ability to work effectively with colleagues from myriad cultures, backgrounds and geographies.
Strong verbal and written communication skills.
Ability to work within existing organizational structures and interact with individuals of varying expertise.
Open, engaging, and transparent work style
Comfortable questioning the status quo and advocating for different opinions with internal and external partners.
Required Experience
Professional knowledge of the principles, theories, and practices of clinical medicine acquired through an M.D. degree or equivalent.
10+ years of experience in clinical research related to the position, including experience and leadership roles in phase 1, 2, and 3 clinical trials.
6+ years of vaccine research, development and deployment, encompassing the latest developments and advances in the field.
PATH is dedicated to building an inclusive workforce where diversity is valued.
PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, gender identity or orientation, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Apply via :
path.silkroad.com
