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Executive Medical Director, Oncology, Solid Tumors
4 months ago
**Company Description**
The Executive Medical Director is responsible for the safety strategy for solid tumors late-stage oncology portfolio, and to supervise, manage and mentor the safety physicians (Group MDs, Senior MDs and medical directors) and the MSE staff supporting the hematology in the Oncology TA. The Executive Medical Director will be the oncology safety team connector across R&D, will promote forward thinking safety strategy for the hematology oncology platform in late stage.
**Responsibilities**:
- Set safety strategy for the solid tumors late-stage portfolio considering AbbVie Oncology priorities.
- Help Develop the strategy for a personalized safety approach trough collaboration with internal partners such as precision medicine.
- Safety representative for cross-functional teams across assets and the counterpart to the Executive Medical Director for the product/portfolio on the Clinical Team.
- Overarching experts in solid tumors space including in depth understanding of SOC, disease characterization based on biomarkers and line of treatments.
- Keeping the solid tumors knowledge up to date (up to date on NCCN, ASCO, ASH, EHA and ESMO guidelines, targeted conference attendance) including understanding of competitive intelligence and emerging internal data (clinical and beyond)
- Managing and mentoring Group Medical director/s and Product Safety Team Leads and other safety colleagues within Oncology/hematology area.
- Interacts with and influences other cross functional departments (e.g. Clinical Development, Regulatory Affairs, Medical Affairs), as needed, to ensure the successful development, design, and implementation of comprehensive safety assessment to support both study participants in asset development programs and patients on the marketed product.
- May be involved in external communications regarding assets/portfolio safety.
- Provides strategic input for key safety documents for each asset within solid tumors portfolio including but not limited to:
- Assures all issued safety documents contain high quality medical safety content and are clearly written.
- Supervises and coordinates with the Product Safety Team Leads the communication of major safety issues for assets across all indications and development programs (as appropriate) to various cross-functional teams.
- Communicates major safety issues for solid tumors portfolio to management groups such as the leadership team of RQS, governance bodies such as the Safety Review Board and the Complaint Management Review Board.
- Represents MSE in assigned due diligence activities for oncology, and coaches/oversees direct reports in the conduct of such activities
- Coaches and mentors safety staff and solicit relevant feedback from outside MSE to assist each employee in her/his development and succession planning.
- Drives process improvement and change management in concurrence with companywide and functional plans.
- Drives and advances medical safety capability and capacity both strategically and with innovative approaches, including exploring future technologies (AI, machine learning, digital health tools, etc )
- Develop a personalized safety approach where based on the per-existing risks a patient may be treated with a “tool” vs “another; Establishes platform level best practices
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Work collaboratively and lead cross-functional teams
- Ability to lead cross-functional teams in a collaborative environment
- Fluency, both written and oral, in English
- Evaluate and make independent decisions. Ability to work effectively in situations of uncertainty and complexity, ability to multi-task.
Significant Work Activities:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
**Qualifications** Qualifications**:
- MD / DO with internal medicine residency, direct experience in patient management experience.
- Oncology Fellowship preferred but not required.
- Clinical pharmacology fellowship or PhD is preferred in addition to MD / DO, not required
- Direct patient management/ clinical experience beyond residency is preferred
- 10+ years in pharmaceutical industry and in particular in Clinical Safety / Clinical Development
- Direct Experience in NDA submissions from pharmacovigilance/Clinical development side is required
- At least 3 years’ experience in managing people is required.
**Experiences / Leadership traits**:
- Ability to work collaboratively with colleagues with different areas of expertise (e.g regulatory, clinical, Med Affairs, toxicology, statistics,)
- Ability to make independent decisions - Ability to influence cross functional stakeholders - internal and across industry, and regulatory authorities
- A clear and solid understanding of PV and clinical development (across life cycle), monit
