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Medical Director, Late Development, Sigvotatug Vedotin

Medical Director, Late Development, Sigvotatug Vedotin

1S2 Seagen IncMY
14 days ago
Job description

ROLE SUMMARY :

The medical director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, and analysis. The medical director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups.

ROLE RESPONSIBILITIES :

Study-level Clinical Development Leadership

Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives.

  • Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
  • Lead peer-to-peer interactions with investigators.
  • Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
  • Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.

Strategic Guidance, Clinical Insights & Interpretation

  • Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
  • Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.
  • QUALIFICATIONS :

  • Medical degree (MD)
  • Relevant clinical or industry experience considered
  • 2-5 years industry experience
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including : the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

    Ability to travel to relevant international scientific congresses and internal team meetings 3-6 times per year

    Work Location Assignment : Hybrid

    Work Location Assignment :  Hybrid

    At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including :

    Paid parental leave

    Access to Health & Wellness apps

    Career Growth Experiences program

    Recognition & rewards program

    Paid volunteer days

    Life Insurance Benefits

    Pfizer Learning Academy access to top content providers

    Access to flu vaccines & skin checks

    Options to purchase additional leave

    Salary packaging & novated lease options

  • Benefits listed may vary depending on your position and location and may be subject to change.
  • Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across : Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

    If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

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