Associate Director, Team Lead, Global Clinical Drug Supply - Operations
- Lead a team of approximately five individual contributors providing guidance, mentorship and support to ensure strong individual and team performance.
- Set clear operational standards and foster a collaborative, high-performing culture.
- Act as an individual contributor with direct responsibilities for early- and late-stage clinical assets including development, implementation and maintenance of strategic plans and provide oversight across packaging and distribution setup.
- Provide expertise and insight into operational planning and execution with an innovative and inspection-ready mindset.
- Drive and support trouble shooting and development of risk mitigation plans.
- Define, lead, organize, and execute inspection activities e.g. related to submissions to EMA, FDA and PMDA as well as other periodic inspections and audits.
- Drive and contribute to implementation activities related to Global Clinical Drug Supply strategies and build of capabilities operationally in collaboration with Global Clinical Drug Supply Planning and Systems teams.
- Drive and participate in maintenance of SOPs for the Global Clinical Drug Supply area with focus on operational aspects.
- Define, lead, organize, and execute cross functional projects driven by Global Clinical Drug Supply Operations team.
- Stakeholder engagement and collaboration related to drug supply operations e.g., GMP QA and CMOs/vendors for packaging, labelling and distribution.
- Contribute to maintenance of CMO landscape and outsourcing strategy for Global Clinical Drug Supply Operations including acting as Vendor Relationship Manager of selected CMOs.
- Have an oversight of country specific regulations for using trial supplies and ensure compliance and implementation of new regulations.
- Supervise, train, and educate colleagues in Global Clinical Drug Supply Operations.
- Set standards for operational work and compliance and support overall strategic direction and development in department.
- Responsible to be compliant with Genmab´s quality system.
- 6+ years' experience in handling clinical drug supply, including setting up label text, handling of ancillaries, distribution with cold chain management from CMO, Biotech or Pharma companies.
- Proficient in leading a team and your leader.
- Proven ability to balance dual responsibilities; leading a team while delivering as an individual contributor on complex projects.
- Extensive knowledge and understanding of GMP, GDP, and GCP.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support global clinical trial supply strategy.
- Strong communication skills in English - both oral and written.
- 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
- 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!
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