Vice President, Regulatory Affairs (Remote)

VICE PRESIDENT, REGULATORY AFFAIRS (REMOTE)

POSITION SUMMARY

The Vice President, Regulatory Affairs is responsible for developing and directing Partner Therapeutics' ("PTx") regulatory strategy, objectives, policies, and programs from IND planning through NDA and future commercialization. This position will serve as the regulatory lead for developing and providing strategic regulatory direction and guidance on Company projects and key strategic business initiatives. This role will also drive the operational aspects of regulatory compliance and submissions for all programs including CMC, discovery, preclinical, and clinical as well as for all post-approval obligations.

PRIMARY RESPONSIBILITIES

Functional:

• Establishes the strategic vision for Regulatory Affairs and ensures its successful execution.
• Leads the preparation and filing of all regulatory submissions and establishes the strategy for submissions of product registration documents to health authorities worldwide.
• Establishes and maintains excellent relationships with regulatory agency personnel. Responds to any requests for additional data and organizes/manages participation in meetings. Negotiates directly with regulatory authorities regarding PTx's filings and proactively addresses inquiries and facilitates effective communication throughout the regulatory review process.
• Collaborates with cross-functional teams to ensure regulatory requirements are integrated into development programs and commercial strategies. Works with internal teams to develop content and resolve complex issues. Assists in the design and interpretation of results for clinical studies required for regulatory approvals.
• Oversees and directs external regulatory consultants, vendors, and/or CROs, as applicable, to ensure successful execution.
• Evaluates and manages regulatory risks, including establishing regulatory infrastructure, processes, procedures, and systems to ensure compliance with applicable US and international regulations and guidelines.
• Monitors regulatory landscape and communicates new or changing regulatory developments related to the PTx's portfolio. Advises colleagues and project teams of potential strategic impact and/or areas of regulatory concern. Recommends responses to new government/regulatory developments.
• Provides input on clinical trials and filing activities and ensures that document systems are maintained and compliant.
• Identifies regulatory operations or processes in need of improvement and leads the development and implementation of appropriate improvements.
• Actively participates in Company governance committees as required.
• Manage Regulatory Affairs planning process and budget.
• Oversees and contributes to the creation of policies, procedures, standards, and controls to enhance the support and adherence to U.S. and applicable international regulatory agencies.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required timeframes.
• Resolves "stuck" issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations from occurring in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. "collateral duties") as they become available to support personal growth, connection, and business needs.

People Leadership:

• Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve.
• Establishes departmental and individual goals and objectives in alignment with Function goals and priorities. Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets.
• Works pro-actively and in close collaboration with Leadership teams and People & Culture to recruit, hire, grow, and retain a diverse team of talent.
• Manages and develops the performance of direct reports by setting clear goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance. Leads by example and promotes PTx's core Values: Learn, Prepare, Innovate, Collaborate, and Lead to continually improve the Quality Culture at PTx. Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners (as needed), and enhances the Team through cross-training others, identifying competency gaps, etc.
• Meets consistently with all Direct Reports in 1:1 format and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly.
• Through active leadership and coaching, while embracing PTx's Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support other regulated activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
• This job description is not intended to be all-inclusive. Partners may be required to perform other related duties as required to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Possesses deep understanding of the patient and stakeholder/customer viewpoint.
• Extensive, recent experience with regulatory filings to the FDA including a proven track record of success in supporting Phase I-III clinical trials and progressing programs to completion with the FDA.
• Knowledge of relevant agency guidelines and regulations as well as recent guidance/changing practices relevant to the Company's portfolio.
• Demonstrated excellence in regulatory liaison/strategy & effective negotiations with regulatory authorities.
• Possesses excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to anticipate, assess and mitigate regulatory challenges and risks. Proven track record of creating novel, creative solutions to regulatory issues.
• Resourceful with proven ability to lead, manage and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues. Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Track record of successfully building the regulatory infrastructure needed in a maturing biopharma company.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity, innovation, and priority-setting in order to complete projects on-time and on-budget; experience with the principals of operational excellence and project management. Demonstrated ability to delegate successfully.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
• Strong written and oral English communication skills are required for this highly collaborative role. Proven ability to make clear, effective, and persuasive presentations to audiences at various levels of expertise required. Skilled at leading effective meetings.
• Solid software skills essential including Word, Excel, PowerPoint, Outlook; ability and willingness to quickly adopt other job-specific applications, such as regulatory systems, will be necessary.

Preferred:

• Experience with international regulatory submissions and an understanding of worldwide guidelines and regulations
• Software application experience with Smartsheet, MS Project, and SharePoint.

PEOPLE LEADERSHIP QUALIFICATIONS

Required:

• Demonstrated commitment to fostering the professional growth and development of others.
• Strong leadership skills included a demonstrated ability to drive accountability and build a culture of trust, compliance, efficiency, and continuous improvement.
• Proven ability to enhance engagement by driving an environment within which individuals can excel and continuously improve.
• Skilled at active listening, conflict resolution, and team building.
• Significant experience working collaboratively with HR/People & Culture functions to recruit, hire, grow, and retain talent. Proficiency in standard recruiting and hiring protocols; recent practical experience with the hiring processes as both a hiring manager and interviewer.
• Experienced at managing and developing the performance of direct reports by setting clear goals, providing timely performance feedback, recognizing, and rewarding high achievers, and holding staff accountable for underperformance.
• Prior formal training supporting the development of PTx-level People Leadership skills.

Preferred:

• Formal people leadership training including advanced coaching and giving-and-receiving-feedback skills.

EXPERIENCE & EDUCATION

Required:

• BA, BS or equivalent degree in a science-based discipline required
• 15+ years of progressively responsible regulatory experience in Biotech, Pharma or Clinical Research Organization with extensive experience in Regulatory strategy.
• 10+ years of experience in People Leadership roles.
• Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements.
• Experience working with CROs and managing regulatory consultants and vendors.
• Experience in the Oncology field required.

Preferred:

• Advanced degree (MS/PhD/PharmD) strongly preferred.
• Experience developing companion diagnostic regulatory strategy preferred.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $264,200 - $362,000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year's holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.