Executive Director, Clinical Sciences

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

We are a dynamic and innovative company focused on harnessing the power of the immune system to bring curative therapies to cancer patients. Join us as the ED, Clinical Sciences at the most exciting time in our 25+ year history. Reporting to Agenus’ Chief Medical Officer, you will define strategy and drive implementation of drug development and scientific communications with a focus on mid to late-stage development. You will be responsible for shepherding a unique and deep portfolio of first in class assets from development to BLA filing and will be instrumental in building the company’s clinical development organization.

The successful leader will play a pivotal role in ensuring alignment between clinical strategy and clinical study protocols, operational structure, formalized processes, and tactical execution.This individual will enhance the execution of the vision, mission, and values of Agenus by keeping a watchful eye on the moving parts and the dynamic environment while ensuring teams and programs are moving forward within scope, schedule, and budget. In addition, the ED of Clinical Sciences will provide management and oversight for the Clinical Scientist team at Agenus.

In The Role You Will

• Clinical Study Design and Implementation: Collaborate on design, initiate and implement phase I-III studies in partnership with cross-functional teams including medical directors, clinical operations, regulatory, biometrics, medical affairs, and competitive intelligence.Clinical support on implementation teams, providing subject matter expertise, clinical science support and functional representation.
• Leadership and Team Management: Establish and manage a team of Clinical Scientist professionals responsible for the development of clinical research protocols, clinical study reports, and scientific publications. Leading the Clinical Scientist team including allocating resources effectively, and driving strategic initiatives to advance clinical projects, fostering collaborative environments, budgeting and career development.
• Strategic Leadership: Interact with key opinion leaders, partners, and investigators to guide clinical development. Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization. Ensure consistency of scientific and development strategies for assets in development. Maintain the highest level of ethics and scientific and clinical knowledge.
• Communication: Maintain timely and effective communication with stakeholders including the Agenus Leadership Team, clinical trial team, investigators, and regulatory authorities as needed. Metrics: Feedback from stakeholders including sites on the quality and timeliness of communication
• Regulatory and Compliance: Oversee the coordination and development of reports submitted to the FDA, including responsibility for clinical sections of regulatory documents such as BLA filings.Ensure projects comply with federal regulations, GCP and good medical practice.Write and/or review clinical sections of clinical/statistical reports, including data presentations and other regulatory submissions.
• Data Management and Review: Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.
• Extensive experience with electronic systems for data review (RAVE, Spotfire).Hands on SOP development for data review to unify the activity across Agenus Programs.Coordinates process for protocol deviations and SAE reconciliation.Ensures consistent, quality data review and supports the clinical science team. Identifies and escalates clinical data trends to Medical Program Lead
• Safety and Pharmacovigilance: Collaborate with and oversee pharmacovigilance in analyzing and reporting safety data from clinical trials. Provided comprehensive gap analyses for clinical development programs at risk. Draft safety narratives and review vendor-authored safety narratives to support various regulatory activities.
• May serve as the Medical Monitor depending on prior experience and expertise.
  
  

Qualifications: About You

• Degree in Life Sciences (MD, PhD, Pharm D) board certification in oncology and significant research experience in immuno-oncology.
• Strong clinical training, deep industry expertise and a passion for clinical medicine, drug development and immuno-oncology: t en or more years in pharmaceutical/biotech industry or a combination of academia and industry.
• Outstanding in-person and written communication skills.
• Ability to thrive in a dynamic and innovative biotech environment with independence and collaboration.
• Proven deep expertise in the design, execution, and reporting of phase II and III clinical trials in oncology including immuno-oncology.
• Excellent scientific knowledge relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
• In-depth knowledge of medical aspects of GCP, ICH, FDA, guidelines and regulations.
• Proven leadership capabilities
• Decisiveness and the ability to perform as a respected team member and leader.
  
  

# LI-JW1

Read more about our pipeline and visit us on LinkedIn

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

• Highly competitive and inclusive medical, dental and vision coverage options (US & UK)
• Flexible Spending Accounts for medical expenses and dependent care expenses (US)
• Flexible Vacation Plan (US & UK)-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.
• Care.com Memberships (US)
• Education Assistance Program (US & UK)
• 401k match (US) and Financial Planning tools, Private Pension (UK)
• Employee Stock Purchase Plans (US &UK)
• Employee Assistance Program (US &UK)
• Reward & Recognition Program (US & UK)
• Catered Lunch (site dependent)
• Onsite Yoga (UK)
• Free Parking (US & UK)
  
  

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.