Senior Manager, Regulatory Affairs Cmc

We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

The Role

The incumbent is responsible for hands on oversight and support of CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs (RA) activities for antibody directed cancer therapeutics.

This role will provide expert guidance and evaluation of CMC content from an RA perspective to support a range of regulatory submissions in the US and globally. Oversight and input will of necessity involve Module 3 content gap assessments, strategy and tactical approaches to presentation of information. Submission types include annual reporting through to marketing authorisation applications in multiple regions. A very strong technical background with demonstrable writing and verbal communication skills is a must. Due to the type of content and complexity of information involved, an advanced scientific degree (i.e., MS or PhD) is highly preferred in conjunction with 6-8 years of progressively responsible RA and RA CMC support from a global perspective.

In The Role You Will

• Participates with senior management to establish strategic plans and objectives.
• Works on complex issues where problems are not clearly defined and where fundamental principles do not fully apply.
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
• Effectively cascades functional strategy and contributes to development of organizational policies.
• Accountable for actions that impact function or multiple department budgets.
• Directs the activities of a functional area or multiple integrated departments through lower management.
• Ensures budgets and schedules meet corporate requirements.
• Provides strategic and tactical input to limit erroneous decisions will have a critical long term (typically up to five years) impact on the overall success of function or multi departments.
• Translates business segment strategy into functional plans and guides execution.
• Leads team(s) to develop new methods and solve complex matters.
• Contributes to development of strategies of a function or multi departments.
• Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
• Makes final decisions on implementation and ensures operational effectiveness.
• Reconciles multiple stakeholder views to drive business results.

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

• Care.com Memberships
• 401k match and Financial Planning tools
• Free Parking
• Catered Lunch
• Employee Stock Purchase Plans
• Employee Assistance Program
• Education Assistance Program
• Flexible Vacation Plan-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission
• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses

Our core values

The way we work sets Agenus apart.

We put the patient first

We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.

We are bold, and we are one

We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.

We work with integrity, respect and honesty

These three building blocks serve as pillars for how we behave, operate, and execute our mission.

We are a culture of ownership and accountability

We hold ourselves accountable not only for exceptional results, but how we get our results.

We are obsessively curious and deeply committed to learning

We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.

We perform at our best every day

Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.