To lead the oncology therapeutic area by providing strategic safety leadership and expertise, continuous development and mentoring of TA staff, logistic and other staff planning activities as warranted. Will serves as the TA safety core member on select goverance governance committees; and ensures the efficient functioning of the Global Safety Teams global safety framework.
The Global Safety Executive Medical Director TAH will lead by supervising and managing the direction of the oncology portfolio:, including providing high level safety strategy, personnel and resource management, mentoring of staff, and providing cross-functional safety leadership at key governance meetings.
•Accountable for review and approval of all regulatory responses or strategic GST deliverables including but not exclusive to RMPs, PSURs, PSAPs, GSSP, SARs
• Represent TA in meetings with Management/governance boards, regulatory agencies and external partners
• Provide timely safety input to GRAAS Leadership, senior management review committees, and governance boards as needed.
• Provide functional expertise to guide the development of new department and cross-functional processes
• Advise and approve Individual Development Plans and Goals for TA staff members
• Work cross-functionally with Regulatory TA Heads to reach GST issue resolution on safety related issues.
• Monitor TA staff compliance with assigned SOP and compliance training
• Lead significant cross-functional projects or initiatives
• Extensive knowledge of drug development (Non clinical, clinical and CMC aspects), global pharmacovigilance principles, commercialization, and safety escalation governance processes, global regulatory authority operations, global regulatory agency submission process, technical skills (such as Microsoft Outlook, Word, Excel, Power Point); ;and working globally.
• Visionary strategic leadership abilities (Charts the course). Proven track record as an effective team and strategic leader in a Matrix environment (as well as working with a subsidiary company of a larger organization). Issue and conflict management skills required. Strong interpersonal skills needed to navigate cross functionally between 2 companies and outstanding communication skills including oral and written (medical writing) required. Also must possess strong negotiation, critical thinking and problem solving skills.
Accountable for budget and administration for sizeable operations for a sub-function OR Accountable for budget and operations for a medium-sized site. Collaborates with sub-functional leadership to set strategy and business objectives.
Establishes operational objectives for managers and/or teams of professionals across the sub-function – Guided by functional strategy. Provides authoritative advice to top management based on deep subject matter expertise.
Leads a team of other global safety officers and safety scientists who are accountable and responsible for the global safety of the oncology portfolio. . Develops budgets, schedules and performance requirements. Builds long-term development and succession plans.
Collaborates with key stakeholders (e.g Internal- safety platform lead, VP of safety, International Safety lead, VP of regulatory, SVP development) – Applies influence and negotiation skills to drive business results – Serves as important liaison to external contacts.
MD or DO degree from an accredited medical school with 6 years of work experience
Completion of an accredited medical or surgical residency
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Strong publication track record
• Previous drug safety experience
• Knowledge of clinical trials and drug development
• Knowledge of all therapeutic area patient populations and drug classes
• Issue and crisis management