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Feasibility Lead

2 months ago

Plainsboro, New Jersey, United States Genmab Full time
Job Description

At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department

The Senior Feasibility Manager supports the vision and strategy set forth by the Head of Strategic Feasibility. Advances this effort through the coordination and development of data-driven early indication and program assessments, study-level feasibility assessments, robust country and site identification, support of Diversity, Equity, and Inclusion (DEI), recruitment projections, and any retention recommendations, across all phases of development.

Partners with key stakeholders within Global Development Operations (GDO), Medical Affairs, Medical, and/or Contract Research Organizations (CROs), to enable expedited, predictive delivery for all stages of global feasibility. Ensure standardization in use of data, tools and processes to inform risk-benefit decision making at Therapeutic Area (TA), program and study levels.

This position reports to our Princeton, NJ office and is field-based.

Responsibilities:

  • Accountable for leading and conducting the end-to-end data-driven feasibility process.
  • Proactively seeks input from customers, which may include patients, sites and other Genmab functions both in and outside of GDO.
  • Responsible for the creation and maintenance of study-level patient enrolment forecast based on final operational plan approval and final feasibility. Key Performance Indicators (KPIs) developed and shared across the study team as part of year end objectives.
  • Point of contact for assigned program and study-level feasibilities, leading cross functional teams to develop, validate and refine allocation strategy, inclusive of timelines, scenarios, and risk mitigation plans.
  • Identifies and resolves events in the indication landscape (e.g. competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.
  • Key contributor to the study's operational plan.
  • Actively engages in continual process improvement; gathers cross-functional feedback and depending on business needs, this position may take leadership and/or will participate in initiatives that are at the intersection of technology, process and development experience.
  • Develops and maintains strong relationships with internal stakeholders, including GDO, Medical Affairs, Medical, and CROs.

Requirements:

  • Minimum 5 years of direct feasibility experience in the pharmaceutical/CRO/biotech industry.
  • Proven experience in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans aligned to the commercial and regulatory objectives.
  • Excellent stakeholder management, concise written communication, ability to influence, clearly communicate and collaborate across an increasingly complex matrix environment.
  • Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.
  • Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV, including health authority guidelines.
  • Experience with MS Office and other (relevant) systems/tools.
  • Excellent communication skills in English, both verbal and written.
  • Approximately 5% business travel (overnight) required for internal meetings and congresses.

Attributes of a successful candidate:

  • Self-starter; motivated by working in a fast-paced, ambiguous environment.
  • Strong analytical skills with the ability to identify, define and optimize ways of working /processes that are not yet formalized or described.
  • Excellent communication and facilitation skills.
  • Able to work respectfully, knowledgeably, and effectively with all nationalities in a global environment.
  • Global mindset and ability to partner (cross functionally) that fosters trust.
  • Ability to work independently in a structured and systematic way, keep the appointed deadlines and lines of communication open.
  • Demonstrates self-awareness and ability to receive and provide constructive feedback for development.

Where you will work

This position will report to the Princeton, NJ USA office and is field-based.

For US based candidates, the proposed salary band for this position is as follows:

$142, $237,500.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ).

Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.