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- Tasks: Lead oncology clinical trials, ensuring patient safety and adherence to regulations.
- Company: Join a well-funded biotech focused on innovative cancer treatments.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Make a real impact in oncology while working with top experts in the field.
- Qualifications: MD or equivalent with 4-6 years in Oncology and clinical trial experience.
- Other info: Work closely with US teams and contribute to global regulatory interactions.
The predicted salary is between 72000 - 108000 £ per year.
Our client, a public clinical stage well-funded biotech, is looking for an EU-based Medical Director/Senior Medical Director in Clinical Development who will serve as the Clinical Lead for one or more oncology clinical trials. The Medical Director will work cross-functionally with our US-based team and EU sites on clinical development strategy, clinical trial design and execution, including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions.
Responsibilities:
- Serve as the medical monitor for assigned studies including design, execution and interpretation of study data.
- Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
- Act as liaison between Clinical Development and other internal groups for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
- Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
- Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Serve on cross-functional teams for assigned programs, working with other team members to drive programs and clinical strategy to registration in applicable populations and indications.
- Establish strong collaborations with study investigators, outside medical experts and represent Bicara during investigator meetings and advisory boards.
- Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas.
- Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).
Qualifications:
- MD, DO or equivalent ex-US medical degree with 4-6 years of experience in Oncology.
- 2-4 years clinical trial experience, experience with phase 1 trial is a plus.
- Pharmaceutical/Biotech industry experience in clinical development and medical monitoring.
- Strong oral and written communication skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- Ability to work independently to resolve challenges.
Senior Medical Director employer: Algernon Group
Contact Detail:
Algernon Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Director
✨Tip Number 1
Network with professionals in the oncology field, especially those who have experience in clinical trials. Attend industry conferences and seminars to meet potential colleagues and learn about the latest trends in clinical development.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for clinical trials in Europe. Understanding the nuances of EU regulations can set you apart from other candidates and demonstrate your commitment to patient safety and compliance.
✨Tip Number 3
Highlight your experience in cross-functional collaboration during interviews. Be prepared to discuss specific examples where you've successfully worked with teams across different departments, as this is crucial for the role.
✨Tip Number 4
Stay updated on the latest advancements in oncology and clinical trial methodologies. Being knowledgeable about current research and innovative practices will show your passion for the field and your readiness to contribute effectively.
We think you need these skills to ace Senior Medical Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in oncology and clinical trials. Emphasise your medical monitoring skills and any specific achievements in previous roles that align with the responsibilities of a Senior Medical Director.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this position. Discuss your experience in clinical development, particularly in oncology, and how it prepares you for the challenges of this role. Be sure to mention your collaborative skills and ability to work in a fast-paced environment.
Highlight Regulatory Experience: Since the role involves contributing to regulatory documents, make sure to detail your experience with INDs, CTAs, and interactions with regulatory authorities. This will demonstrate your understanding of the regulatory landscape and your capability to navigate it effectively.
Showcase Communication Skills: Given the importance of strong communication in this role, provide examples of how you've successfully communicated complex scientific information to diverse audiences. This could include presentations, publications, or leading cross-functional teams.
How to prepare for a job interview at Algernon Group
✨Know Your Oncology Inside Out
Make sure you have a solid understanding of oncology, especially the latest trends and treatments. Be prepared to discuss your experience with clinical trials in this field, as well as any specific phase 1 trial experience you may have.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working closely with various teams, be ready to share examples of how you've successfully collaborated with different departments in previous roles. Highlight your ability to facilitate communication and coordination among diverse groups.
✨Showcase Your Regulatory Knowledge
Familiarise yourself with the regulatory processes relevant to clinical trials, particularly in Europe. Be prepared to discuss your experience with regulatory submissions and interactions with authorities, as this will be crucial for the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and decision-making abilities in clinical settings. Think of specific scenarios where you had to ensure patient safety or resolve challenges during a trial, and be ready to explain your thought process.
