Associate Director, North American Regional Leader

Purpose

The Associate Director, North American Regional Leader, is responsible for North American and global regulatory strategies for select projects spanning the oncology therapeutic area. This role supports the initiatives for the Interventional Oncology group (INTO). The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor.

Responsibilities

• Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs & supplements.
• Serve as primary point of contact for US FDA.
• Lead the regulatory response team for FDA and Health Canada questions.
• Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
• Manage routine maintenance submissions, coordinate NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities.
• Contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.
• Collaborate with cross-functional submission delivery teams.
• Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members.
• Ability to flex across different product types (pharma, devices, combo products).
• Intellectual curiosity and ability/flexibility in learning new things and working in novel areas with limited regulatory precedence. This role will include an opportunity to flex across different product types (pharma, devices, combo products).

Qualifications

• Minimum of a Bachelor's degree in scientific or equivalent discipline
• Bachelor's degree plus 8+ years relevant experience OR; Master's degree/PharmD plus 6+ years relevant experience, OR; PhD plus 4+ years relevant experience
• Relevant regulatory experience and understanding of clinical drug development, working with US FDA and global regulatory health authorities
• Experience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactions
• Experience in lifecycle management of IND/NDA and other regulatory submissions
• Demonstrated experience in critically reviewing and compiling regulatory documents is required

Preferred Skills and Experience

• Oncology experience highly preferred; diverse therapeutic area experience; Experience with companion diagnostics, combination products and/or biomarker development, or medical device is beneficial
• Proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization
• The ability to effectively prioritize assignments for multiple products and projects simultaneously
• Strong interpersonal and communication skills
• Experience people management/coaching/mentoring is preferred
• Leadership capabilities and ability to work successfully in a matrixed environment
• Exercises strong organizational and time management skills
• Exercises independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions
• Demonstrated ability of strategic thinking and contingency planning with respect corporate objectives
• Effective critical thinking including problem solving and goal setting for improved efficiencies
• Strong collaboration skills, including effective communication and conflict resolution skills
• May cultivate and leverage strategic networks and partnerships
• 10% domestic travel and potential international travel maybe required for this position

Pay

The anticipated base pay range for this position is $137,000.00 - $235,750.00.

Benefits

• Consolidated retirement plan (pension) and savings plan (401(k))
• Long-term incentive program
• Vacation – 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year