Associate Director, Feasibility Lead

Genmab•Plainsboro Township, NJ

About The Position

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 Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. They advance the effort to build and grow the Genmab Strategic Feasibility team through the coordination and development of data-driven early indication and program assessments, study-level feasibility assessments, robust country and PI/site identification, recruitment projections, and protocol optimization recommendations across all phases of development. Partners with key stakeholders within Development Operations (DevOps), Clinical Strategy, Program Management, and/or CROs, to enable expedited, predictive delivery for all stages of feasibility. Ensure standardization in use of data, tools and processes to inform risk-benefit decision making at TA, program and study levels.

Requirements

Minimum 5 years of direct feasibility experience in the pharmaceutical/CRO/biotech industry as a feasibility lead or equivalent.
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 country/site 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.

Nice To Haves

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.

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 DevOps.
Responsible for the creation and maintenance of study-level patient enrolment forecast based on final operational plan approval and final feasibility.
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.
Identify and resolve 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.

Benefits

401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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