Director, Medical Affairs
Director, Medical Affairs
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$ 230000 - 288000
1 Vacancy
Job Description
About Summit:
Ivonescimab known as SMT112 is a novel potential first-in-class investigational
bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis 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 PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small 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 EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).
HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 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:
Summit Therapeutics is seeking an experienced and dynamic Medical Affairs Director to lead the development and implementation of medical strategies for ivonescimab targeting different solid tumor cancers. This role will involve close collaboration with cross-functional teams including clinical development regulatory affairs and commercial operations to support the investigation and eventual commercialization of ivonescimab in different indications. The ideal candidate is able to demonstrate effective planning and execution of medical affairs strategies leading to a successful development or adoption of an oncology therapy as well as ability to analyze summarize and deliver complex scientific data to a multitude of audiences.
Role and Responsibilities:
Role and Responsibilities:
- Lead the creation and execution of the medical affairs strategy for ivonescimab in different solid tumor cancers.
- Devise and execute a medical affairs plan to gather external input and disseminate relevant information for several solid tumor indications. The plan should include identification and engagement with relevant key opinion leaders development and execution of advisory board meetings execution of a strategic medical publications program utilization of MSL led KOL engagements drive support of relevant investigator sponsored trials programs and more.
- Provide medical and scientific input into clinical development plans ensuring alignment with regulatory requirements and commercial objectives.
- Collaborate with clinical development teams to design and implement clinical trial protocols including pivotal studies and post-marketing investigations.
- Establish and maintain strong relationships with key opinion leaders (KOLs) healthcare professionals and academic institutions to foster collaboration and gather insights on therapeutic approaches.
- Represent the company at medical and scientific conferences presenting data and findings related to the novel therapy.
- Develop and deliver high-quality medical education and training materials for internal and external stakeholders including employees healthcare providers and regulatory bodies.
- Ensure accurate and compliant communication of scientific data and therapeutic benefits to various audiences.
- Ensure all medical affairs activities comply with relevant laws regulations and ethical standards.
- Work closely with product strategy and commercial counterparts to develop and implement launch strategies and market access plans.
- Provide medical insights to support marketing strategies and materials.
Experience Education and Specialized Knowledge and Skills:
- MD PhD or PharmD required specialization in oncology or a related field is highly preferred.
- A minimum of 7 years of experience in medical affairs and/or clinical development within the biopharmaceutical industry with a focus on oncology. Experience with novel therapy development including targeted therapies immunotherapies or gene therapies is an advantage.
- Proven track record in leading medical strategy and supporting clinical development for oncology therapies.
- In-depth knowledge of solid tumor biology and current therapeutic approaches.
- Strong analytical and problem-solving skills with the ability to interpret complex scientific data.
- Excellent communication and presentation skills with experience in engaging with KOLs and other external stakeholders.
- Ability to work collaboratively in a fast-paced dynamic environment.
- Ability to interact with senior management academic experts and patient advocates appropriately with confidence and ease.
- Proficient user of standard MS Office suite (e.g. Word Excel) experience using electronic document management systems and document review tools.
- Strong computer and database skills
- Attention to detail accuracy and confidentiality.
- Excellent organizational skills
- Critical thinking problem solving ability to work independently.
- Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
- Work in a fast-paced demanding and collaborative environment.
- Experience with novel therapy development including targeted therapies immunotherapies or gene therapies.
- Domestic and international travel required expected to be 20-30% of the time and as needed.
The pay range for this role is $230000-$288000 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
