Senior Medical Director-Late Stage Oncology

About the role

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head, will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensure safety through the product lifecycle (e.g., surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc.) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross-functional colleagues).

The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.

Responsibilities

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Responsible for safety surveillance for pharmaceutical / biological / drug-device combined products
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission - safety component
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analyses and interpretations to cross-functional teams, executive leadership and externally, as needed
• Effectively write, review and provide input on technical documents independently
• Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
• Responsible for implementing risk management strategies for assigned products
• Proactively engage, inspire, coach and mentor team and colleagues
• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
• Strong team player, able to adapt and work in a fast-paced environment

Requirements

• MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required
• 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required
• Oncology experience strongly preferred
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations/opinions in group environment both internally and externally
• Write, review and provide input on technical documents
• Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment

Qualifications

• MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required
• 5 - 8 years of Pharmacovigiance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required
• Oncology experience strongly preferred

Skills

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations/opinions in group environment both internally and externally
• Write, review and provide input on technical documents
• Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment

Benefits

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

  We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

  This job is eligible to participate in our short-term incentive programs.

  This job is eligible to participate in our long-term incentive programs.

Pay

$211,000 - $400,500 USD

Schedule

Hybrid