Medical Affairs Director, Launch Lead
Medical Affairs Director, Launch Lead
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$ 230000 - 288500
1 Vacancy
Job Description
About Summit:
Ivonescimab known as SMT112 is a novel potential firstinclass investigational
bispecific antibody combining the effects of immunotherapy via a blockade of PD1 with the antiangiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD1 and VEGF.
Summit has begun its clinical development of ivonescimab in nonsmall cell lung cancer (NSCLC) with three active Phase III trials:
- HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFRmutated locally advanced or metastatic nonsquamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).
- HARMONi3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with firstline metastatic NSCLC.
- HARMONi7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with firstline metastatic NSCLC whose tumors have high PDL1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.
Overview of Role:
We are seeking a highly skilled and experienced Medical Affairs Director to lead the medical strategy and tactical execution for the development and launch of ivonescimab in lungrelated indications. This role is pivotal in developing comprehensive pre peri and postlaunch medical activities including disease and product education strategic publications data generation stakeholders engagement and other programs and oversee their execution through the team. The successful candidate will ensure the medical strategy and its execution aligns with regulatory requirements and supports the successful commercialization of ivonescimab.
Key Responsibilities:
- Drug Launch Leadership: Lead the medical strategy for the launch of ivonescimab in lungrelated indications. Develop and execute a comprehensive launch plan including prelaunch activities stakeholder engagement and postlaunch support.
- PreLaunch Education: Develop and implement prelaunch disease and product education programs for healthcare professionals patients and other stakeholders. Create training materials presentations and educational content to ensure a thorough understanding of ivonescimab and its therapeutic benefits.
- Medical Strategy Development: Develop and implement medical strategies for ivonescimab in lungrelated indications ensuring alignment with overall business objectives.
- Regulatory and Compliance Alignment: Work closely with regulatory affairs to ensure compliance with all regulatory requirements and support the preparation of regulatory submissions.
- Stakeholder Engagement: Build and maintain relationships with key opinion leaders healthcare professionals and other stakeholders to support the successful launch and adoption of ivonescimab.
- Data Analysis and Interpretation: Analyze and interpret clinical data to provide medical insights and support decisionmaking processes.
- CrossFunctional Collaboration: Collaborate with crossfunctional teams including marketing sales and market access to ensure the medical strategy supports commercial objectives.
- Medical Information: Provide accurate and uptodate medical information to internal and external stakeholders.
- Compliance: Ensure all activities are conducted in compliance with relevant laws regulations and company policies.
Experience Education and Specialized Knowledge and Skills:
- MD PhD or PharmD required
- Oncology drug launch experience required; lung cancer launch experience is highly preferredLS1
- Minimum of 10 years of oncology related experience in a medical affairs or combination of medical affairs and clinical development role; minimum of 7 years of experience in a lung cancer
- Proven track record in leading medical strategies and supporting launch and on market oncology therapies.
- Strong analytical and problemsolving skills with the ability to interpret complex scientific data.
- Excellent communication and collaboration skills. With ability to demonstrate prior success in working with commercial departments.
- Ability to work independently and as part of a team.
- Detailoriented with strong organizational skills.
- Demonstrated ability to interact with senior management academic experts and patient advocates appropriately with confidence and ease.
- Domestic and international travel required expected to be 2030% of the time and as needed.
- Proficient user of standard MS Office suite (e.g. Word Excel) experience using electronic document management systems and document review tools.
- Must be able to effectively multitask and manage timesensitive and highly confidential documents.
- Work in a fastpaced demanding and collaborative environment.
The pay range for this role is $230000$288500 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Director
Employment Type
Full-Time
