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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 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 and advancing medical science.
- Qualifications: MD or equivalent with 4-6 years in Oncology and clinical trial experience required.
- 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 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 GCP and local regulations can set you apart as a candidate who is well-prepared for the role.
✨Tip Number 3
Demonstrate your leadership skills by showcasing any previous experience leading cross-functional teams or projects. Highlighting your ability to collaborate effectively will resonate well with our hiring team.
✨Tip Number 4
Stay updated on the latest advancements in oncology research and clinical trial methodologies. Being knowledgeable about current trends will not only help you in interviews but also show your passion for the field.
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 fit 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
✨Showcase Your Clinical Expertise
As a Senior Medical Director, it's crucial to demonstrate your deep understanding of oncology and clinical trial processes. Be prepared to discuss your previous experiences in designing and executing clinical trials, particularly in oncology, and how you ensured patient safety and adherence to Good Clinical Practices.
✨Highlight Cross-Functional Collaboration
This role requires working closely with various teams. Share specific examples of how you've successfully collaborated with clinical operations, pharmacovigilance, and other departments in past roles. Emphasise your ability to facilitate communication and coordination across different functions.
✨Prepare for Regulatory Discussions
Since the position involves contributing to regulatory documents and submissions, be ready to discuss your experience with regulatory authorities. Familiarise yourself with the types of documents you'll be involved in, such as INDs and CTAs, and be prepared to explain how you've navigated these processes in the past.
✨Demonstrate Leadership and Independence
The ability to lead and work independently is key for this role. Prepare to share instances where you've taken initiative or led a project, especially in a fast-paced environment. Highlight your problem-solving skills and how you've overcome challenges in clinical development.
