Senior Medical Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead medical affairs and clinical development initiatives, including providing medical oversight for clinical trials.

• Gather scientific advisory feedback and collaborate with external clinical researchers.

• Assist in regulatory discussions to promote product development.

• Work together with clinical operations to offer medical insights and make operational decisions.

• Act as a primary medical authority for various cross-functional teams.

• Utilize oncology treatment and management knowledge to shape Summit medicines’ strategy and clinical progression.

• Formulate comprehensive product strategies across diverse indications in collaboration with Medical Affairs, Regulatory, Commercial, and other departments.

• Partner with Clinical Operations, Biometrics, Pharmacovigilance, and other teams to finalize clinical development programs leading to BLA approvals.

• Oversee clinical trial execution, clinical development strategy, and medical affairs planning.

• Aid in product communications through publications, manuscripts, abstracts, posters, and scientific presentations.

• Contribute to two or more critical clinical development programs.

• Direct Phase 1–3 human clinical trials and assist in achieving development milestones and enrollment targets.

• Review adverse event reports and monitor safety data, assessing and escalating safety signals as necessary.

• Compile information for reports submitted to FDA, EMA, PMDA, and other governmental, regulatory, or partner agencies.

• Present findings to regulators, governing bodies, principal investigators, scientific conferences, advisors, and opinion leaders.

• Support clinical trial planning and execution, ensuring protocol adherence, safety reviews, assay development, training, and clinical document evaluation.

• Plan, review, and edit Clinical Study Reports.

• Plan, review, and edit program publications.

• Offer insights on clinical study design to support clinical strategies.

• Perform additional duties as required.

⛳️ Requirements

• Board certified or eligible MD with experience in hematology/oncology product development throughout various clinical development stages.

• At least 5+ years of experience in a pharmaceutical, biologics, or biotech R&D setting, or in a research environment focused on the collection and analysis of human data in hematology/oncology.

• Solid understanding of clinical development pathways for hematology/oncology therapies in the US and EMA.

• Proficient in English and at least one or more additional European languages (French, Spanish, German, Italian, etc.).

• Competent in using standard MS Office applications, including Word and Excel.

• Experience with electronic document management systems and document review tools is advantageous.

• Strong computer and database proficiency.

• High attention to detail, accuracy, and confidentiality.

• Exceptional oral and written communication abilities.

• Outstanding organizational skills.

• Capable of critical thinking, problem-solving, and working independently.

• Ability to manage multiple tasks and handle time-sensitive and highly confidential materials.

• Proficient in conveying complex ideas clearly.

• Skilled in prioritizing competing demands.

• Comfortable working in a fast-paced, challenging, and collaborative atmosphere.

• Willing and able to travel for investigator engagement, in-person interactions, and protocol training.

🏝️ Benefits

• Potential bonus.

• Stock options.

• Comprehensive benefits package.

• Variable compensation may be included in the overall compensation package.

• Remote work arrangement.