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- Tasks: Lead oncology clinical trials and ensure patient safety while collaborating with cross-functional teams.
- Company: Join a well-funded biotech company focused on innovative cancer treatments.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and collaboration.
- 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 required.
- Other info: This role offers a chance to shape clinical strategies and contribute to groundbreaking research.
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 IND's and CTA's, 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 will not only enhance your knowledge but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in medical monitoring and how you've ensured patient safety in clinical trials. Be ready to provide examples of how you’ve collaborated with cross-functional teams to drive clinical strategies.
✨Tip Number 4
Research the company thoroughly, including their pipeline and recent developments in oncology. This will help you tailor your discussions and show genuine interest in their work during the interview process.
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: In your cover letter, express your passion for oncology and clinical development. Discuss how your background and skills make you an ideal fit for the role, and mention your ability to collaborate with cross-functional teams.
Highlight Regulatory Experience: Since the role involves contributing to regulatory documents, ensure you detail your experience with INDs, CTAs, and interactions with regulatory authorities. This will demonstrate your understanding of the regulatory landscape.
Showcase Communication Skills: Given the importance of communication in this role, provide examples of how you've effectively communicated complex scientific information to diverse audiences, including investigators and regulatory bodies.
How to prepare for a job interview at Algernon Group
✨Know Your Oncology Inside Out
As a Senior Medical Director, you'll need to demonstrate a deep understanding of oncology clinical trials. Brush up on the latest research, trial designs, and regulatory requirements in this field to show your expertise during the interview.
✨Highlight Cross-Functional Collaboration
This role requires working closely with various teams. Be prepared to discuss your experience in cross-functional collaboration, particularly how you've liaised between clinical development, operations, and regulatory affairs in past roles.
✨Showcase Your Communication Skills
Strong oral and written communication skills are crucial for this position. Prepare examples of how you've effectively communicated complex medical information to diverse audiences, including investigators and regulatory bodies.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities and decision-making in clinical settings. Think of specific challenges you've faced in clinical trials and how you resolved them, especially regarding patient safety and GCP adherence.
