Overview of Role:Will be primarily responsible for medical affairs and clinical development including medical oversight of clinical studies. He/she will be responsible for obtaining scientific advisory input, work with external clinical investigators, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence. The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional teams. Medical insight across a myriad of functions from discovery to manufacturing is expected. Investigator engagement including travel to support face to face interaction and protocol training is a vital component of this role. Bladder Cancer Harmoni-GU1: Randomized Phase 2/3 Study of Ivonescimab in Combination with Enfortumab Vedotin vs Pembrolizumab in Combination with Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast paced and intense environment. The Medical Director will work on multiple potentially pivotal programs.
Role and Responsibilities: - Significant Oncology Experience the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients.
- Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications.
- Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals.
- Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning).
- Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations.
- Making vital contributions on2 or more pivotal programs in clinical development program.
- Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals.
- Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals.
- Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies.
- Presentations to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and opinion leaders.
- Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review.
- Planning, reviewing and editing Clinical Study Reports.
- Planning, reviewing and editing publications from the program.
- Providing input on the design of clinical studies supporting clinical strategy.
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills: - Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
- A minimum of 5+ years' experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology
- Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
- Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission.
- Fluent in English and at least one or more other European languages (French, Spanish, German, Italian, etc.)
- Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
- Strong computer and database skills
- Attention to detail, accuracy and confidentiality
- Clear and concise oral and written communication skills
- 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.
- Communicate effectively and articulate complex ideas in an easily understandable way
- Prioritize conflicting demands.
- Work in a fast-paced, demanding and collaborative environment
This is the pay for this position
Pay Transparency
$237,000-$296,000 USD
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.
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