Job Title: Associate Director/ Director, Clinical and Translational Research
Job Type: Permanent
Location: Cambridge, UK
Astex Pharmaceuticals is a world leader in innovative drug discovery and development. The company has successfully applied its proprietary Fragment-Based Drug Discovery platform to generate multiple new drug candidates that are progressing in clinical development. Successful collaborations have led to two launched oncology drugs (Kisqali® partnered with Novartis and BalversaTM partnered with Janssen). Astex continues to grow and focuses on Oncology and Neurological Disorders.
CURIOSITY, CREATIVITY AND INNOVATIVE SCIENCE FOR DRUG DISCOVERY
…UNLOCK YOUR POTENTIAL
The successful candidate will actively participate in all aspects of Clinical and Translational Research at Astex working collaboratively with the Discovery, Preclinical and Clinical Study Team and Project Team contributing to the strategic planning and execution of Clinical Development Plans for Astex compounds in hematology and oncology clinical development.
This individual will be responsible for providing input used for the design of clinical study concepts and writing of clinical trial protocols, IBs, CSRs, and scientific presentations to the highest scientific standards.
This individual will be the primary Medical Monitor for all clinical studies conducted under his/her responsibility and contribute to/provide medical and biomarker data review, analysis, and interpretation from clinical studies.
- Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage.
- Contribute scientific expertise in translational medicine to study teams, project teams and management
- Collaborate with the discovery, preclinical and translational groups to assure alignment of translational medicine strategy
- Contribute medical expertise and provide strategic and clinical input to discovery projects
- Collaborate with Project Management, Clinical Operations, Clinical Science, and Medical Writing departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts, and different scientific presentations.
- Extensive interaction with academic thought leaders to optimize clinical development strategies and clinically manage the conduct of the clinical trials
- For assigned programs/studies, lead the efforts in preparing for conference presentations such as AACR, ASCO, and ASH, and writing and reviewing manuscripts based on the database and CSR
- This individual will be responsible for the clinical and medical content of all clinical and regulatory documents and will ensure the medical and scientific accuracy of all study-related documents
- Responsible for review and analysis of clinical data including safety monitoring in collaboration with Drug Safety
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign-off clinical documents with respect to medical relevance.
- MD/PhD degree; oncologist or hematologist-oncologist
- Board certified with an active medical license is desirable, but not required
- Clinical research experience working for a biopharmaceutical organization or extensive relevant academic experience
- Strong background in the area of oncology translational research
- Familiar and comfortable with clinical concepts, practices, and regulations regarding clinical trials
- Familiar with data processing methods plus general knowledge of clinical and translational medicine, oncology, and medical terminology
- Ability to interact with clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
- Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills.
We offer excellent training and career development opportunities as well as competitive salary and benefits package.
To apply please send your CV and a cover letter, quoting the job reference: AD/1119 to email@example.com
Closing Date: 3rd January 2020
For information on Astex Pharmaceuticals please visit: www.astx.com
and for information on Otsuka Pharmaceuticals please visit: www.otsuka.co.jp