Associate Director, Feasibility Lead

Remote: 
Full Remote
Contract: 
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Offer summary

Qualifications:

Minimum 5 years of direct feasibility experience in the pharmaceutical/CRO/biotech industry., Proven experience in data analysis and interpretation for strategic decision making., Strong understanding of clinical drug development and trial execution processes., Excellent communication skills in English, both verbal and written..

Key responsibilities:

  • Lead and conduct the end-to-end data-driven feasibility process.
  • Create and maintain study-level patient enrollment forecasts based on operational plans.
  • Act as the point of contact for assigned program and study-level feasibilities, leading cross-functional teams.
  • Identify and resolve operational risks in the indication landscape affecting clinical trials.

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Genmab Large http://www.genmab.com
1001 - 5000 Employees
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Job description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role & Department

The Feasibility Lead 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 DEI (as applicable), 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 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 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.  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 an
  • development experience.

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.

Additional Job Description

Lead projects/ operations for a site sub-function or project/business activity within a sub-function OR act as deep technical expert. Provide authoritative technical or professional advice and recommendations through interpretation of complex information to influence internal and/or external cross functional contacts. Manage/ lead projects with tactical results making decisions within a defined framework, influencing team goals and usually with short term impact. Operate with understanding how the needs of other parts of the business and aspects of the external environment may impact their area of responsibility. People manager: Lead a small/ local team to ensure oversight of deliverables, development and regular feedback, ensure effective usage of resources. Individual contributor: Ensure success of project within the sub-function, multiple location.

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

$146,800.00---$220,200.00

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. 

Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional. 
 

About You

  • You are genuinely passionate about our purpose

  • You bring precision and excellence to all that you do

  • You believe in our rooted-in-science approach to problem-solving

  • You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

  • You take pride in enabling the best work of others on the team

  • You can grapple with the unknown and be innovative

  • You have experience working in a fast-growing, dynamic company (or a strong desire to)

  • You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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 (genmab.com).

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.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Microsoft Office
  • Technical Acumen
  • Verbal Communication Skills
  • Self-Motivation
  • Collaboration
  • Adaptability
  • Problem Solving

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