Associate Director, Evidence Generation

Genmab

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profile Job Location:

Princeton, NJ - USA

profile Monthly Salary: $ 171360 - 257040
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

At Genmab we are dedicated to building extranotordinary 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

The Associate Director Evidence Generation will play a key role in executing Medical Affairs Evidence Generation projects for both approved and pipeline products. This position will be responsible for overseeing a molecule program as well as performing operational aspects of Investigator-Driven Programs: Investigator-Sponsored trials (ISTs) Collaborative Research Trials (CRTs) Managed Access Programs (Individual and Protocol) and other initiatives within Medical Affairs.

We have a hybrid model with a requirement of working onsite in the Copenhagen DenmarkUtrecht the Netherlands or Princeton NJ USA office at least 60% of the time.

Responsibilities

The Associate Director Evidence Generation will execute plans with great technical depth and breadth (training & compliance project management medical education grants & sponsorships) define work instructions/process flows within own area/study implement delivery plans and provide periodic reporting in line with overall CoE strategy (e.g. project metrics training outcomes grant outcomes budgets vendor metrics) as well as guide cross-functional and direct team members to drive compliance and address issues related to deliverables. The incumbent will actively contribute in teams and meetings collaborate with other medical affairs groups and external stakeholders as required as well as train and mentor others around new technologies and scientific aspects of applied scientific research.

Oversee successful implementation of Investigator-Driven programs

Successfully develop implement and manage Investigator-Driven Programs

Execute formal review process for proposals protocols and amendments

Facilitate review committee meetings and document decisions

Drive operational timelines and key deliverables for the program or project

Manage proposal lifecycle from submission to study closure

Provide guidance and oversight for the successful management of all aspects of investigator-driven programs within designated program budgets and timelines

Partner with cross-functional teams and alliance partners to manage adjust and revise project timelines/budgets as necessary

Generate regular metrics and reports of program activities and present them to leadership and strategy team as needed

Support field-based teams and MASL teams in executing project/program goals

Work cross-functionally with internal teams which may include development research legal finance supply chain and regulatory

Independently manage ISTs including site coordination document management and drug shipment and payments

Contribute to contract review and negotiations

Communicate project status and issues and ensure project team goals are met

Represent the department at cross-departmental events as needed

Functional expertise to initiate author or contribute to SOP development implementation and training

Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals

Ability to resolve problems using national and international regulations guidelines and investigator interactions

Participate in process improvement exercises to drive operational excellence.

Requirements

Bachelors or Masters or Advanced degree in a scientific discipline

8 years of relevant experience in pharma/biotech industry preferably in Oncology

Program and/or Project management experience with leading teams study protocols or programs preferred

Experience managing global ISTs and/or Medical Affairs initiatives preferred

Therapeutic knowledge in oncology (e.g. lymphoma breast cancer solid tumors) pharma and biologics is a plus

Experience with budgeting and contracting

Experience producing and analyzing metrics/reports

High attention to detail strong analytical and organizational skills

Excellent ability to prioritize workload

Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or independent non-clinical and clinical studies and articulate summary information in verbal and written form

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

$171360.00---$257040.00

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 discretionary bonuses and long-term incentives.

When you join Genmab youre joining a culture that supports your physical financial social and emotional wellness. Within the first year regular full-time U.S. employees are eligible for:

  • 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

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 youre 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 Genmabs 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 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 ().

Please note that if you are applying for a position in the Netherlands Genmabs 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 Experience:

Director

At Genmab we are dedicated to building extranotordinary 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 workp...
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Key Skills

  • Program assessment
  • FDA Regulations
  • Manufacturing & Controls
  • Program Evaluation
  • budget forecast
  • Research Experience
  • Operations Management
  • Research & Development
  • Strategic Planning
  • Contract Management
  • Leadership Experience
  • negotiation

About Company

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Founded in 1999, we are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms ... View more

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