- Leads and oversees oncology drug development programs for successful implementation and conduct of clinical trials including from Phase I-III
- Provides medical and scientific leadership for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilance and study delivery
- Plays a lead role in interactions with global regulatory bodies including the FDA and EMA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and New Drug Applications (NDAs).
- Facilitates the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, CRFs, CSR, meeting abstracts and scientific journal publications
- Collaborates with external vendors such as CROs, external imaging and laboratory resources, as well as global pharmaceutical companies for successful implementation and conduct of early phase and registration global clinical studies
- Serves as a source for medical and scientific expertise in oncology for outlining design strategy and execution for anti-cancer drug development
- Liaises with discovery science to facilitate and further the development of
investigational agents from a preclinical stage to clinical development
- Represents the company at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders
- Detects and analyzes emergent issues during clinical drug development and develops and implements mitigating strategies
- Works in partnership with medical affairs for successful launch of future antineoplastic agents
- Implements the highest ethical and regulatory standards during the investigation and development of anticancer agents
- Provides guidance for successful implementation and accomplishment of investigator initiated trials related to product development and life cycle management of a compound
- M.D. degree preferably with an additional qualification such as a PhD or MSc
- 7 - 10 years of industry experience in oncology drug development
- This position is responsible for providing leadership and establishing strategy and implementing clinical drug efforts for key oncology products (Phase I though Phase III).
- Strong interpersonal, verbal and written communication skills.
- Strong public speaking skills.
- Oral and written proficiency in English (additional language in French or German would be an advantage)
Attractive package inclusive of shares and bonus
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Agency providing Global Staffing services.
- If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)203 868 8607 or e-mail on firstname.lastname@example.org
- If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!