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- Tasks: Lead oncology clinical trials, ensuring patient safety and regulatory compliance.
- 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 will demonstrate your commitment and expertise 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.
✨Tip Number 4
Showcase your ability to collaborate across different functions by highlighting any past experiences where you worked with cross-functional teams. This will be crucial for the role, as it involves liaising with various departments.
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, your understanding of Good Clinical Practices (GCP), and how you can contribute to the company's goals.
Highlight Cross-Functional Collaboration: In your application, provide examples of how you've successfully worked with cross-functional teams in the past. This is crucial for the role, so demonstrate your ability to liaise effectively between different departments.
Showcase Regulatory Knowledge: Mention your experience with regulatory submissions and interactions. Highlight any specific documents you've contributed to, such as INDs or CTAs, to show your familiarity with the regulatory landscape in clinical development.
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 and other departments like pharmacovigilance and quality control.
✨Prepare for Regulatory Discussions
Since you'll be involved in developing regulatory documents, it's crucial to understand the submission process. Familiarise yourself with INDs, CTAs, and safety reports, and be ready to discuss your previous experiences in these areas.
✨Showcase Your Leadership Skills
As a Clinical Lead, you'll need to exhibit strong leadership qualities. Prepare examples of how you've led teams or projects in the past, focusing on your ability to drive clinical strategy and ensure patient safety.
