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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 firm making strides in clinical development.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and collaboration.
- Why this job: Be at the forefront of cancer research, impacting lives 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 therapies.
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 challenges you've faced and how you resolved them, as this will showcase your problem-solving skills.
✨Tip Number 4
Research our company, StudySmarter, and understand our mission and values. Tailoring your conversation to align with our goals will help you stand out as a candidate who is genuinely interested in contributing to our success.
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 trial management. Emphasise your medical qualifications and any specific roles you've held 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 candidate for the role, and mention any successful projects or trials you've led.
Highlight Regulatory Experience: Since the role involves regulatory interactions, be sure to detail your experience with regulatory submissions and compliance. Mention specific documents you've contributed to, such as INDs or CTAs, to demonstrate your expertise.
Showcase Collaboration Skills: The position requires working cross-functionally, so provide examples of how you've successfully collaborated with different teams in previous roles. Highlight any leadership experiences that showcase your ability to drive clinical strategy.
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 impress your interviewers.
✨Showcase Your Cross-Functional Collaboration Skills
Highlight your experience working with various teams such as clinical operations, pharmacovigilance, and quality assurance. Be ready to discuss specific examples where you successfully facilitated collaboration to drive clinical development.
✨Prepare for Regulatory Discussions
Since the role involves contributing to regulatory documents, be prepared to discuss your experience with INDs, CTAs, and safety reports. Familiarise yourself with the regulatory landscape to confidently answer any related questions.
✨Demonstrate Strong Communication Skills
Effective communication is key in this role. Practice articulating complex medical concepts clearly and concisely. Prepare to discuss how you've communicated with stakeholders, investigators, and regulatory bodies in past roles.
