KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.
We see human behind every number
(Associate) Medical Director, Oncology
Location: UK or Poland (home-based)
Due to a growing immune-oncology and oncology portfolio, KCR is seeking an (Associate) Medical Director to support the medical oversight towards its immune therapy projects. The Associate Medical Director will oversee assigned study protocols, provide medical expertise to cross functional study team, including support to safety cases processing and ensuring medical integrity of the data.
At KCR, we offer flexible employment conditions, facilitating continued medical practice and patient care.
Responsibilities:
· Serves as a medical expert providing professional advice to prepare offers and agreements with sponsors (including information for operational department or writing elaboration)
· Provides medical support to Sales and Proposal Department: general medical study feasibility analysis, defining study execution assumptions
· Attends bid defense meetings as needed
· Oversees study protocols, reviews, and provides medical input to essential documents (study protocols, informed consent forms, project management plans, case report forms, safety management plan, data management plan, data review plan, clinical monitoring plan)
· Provides medical support to facilitate ethics/regulatory approvals
· Provides medical coverage during study meetings (kick-off, Investigators’ Meeting, DSMB)
· Leads therapeutic area/indication training for the project clinical team
· Creates expertise and opinion in SOP writing/updating in the fields of Clinical SOP
· Provides ongoing medical support to study team and investigators, including management of eligibility issues
· Provides medical inputs in processing of safety cases, reviews SAE reports and issues SAE queries in scope of medical consistency
· Assesses relatedness and expectedness of the event
· Ensures integrity of medical data and safety signals detection
· Prepares reviews of clinical data in accordance with the Medical Monitoring Plan in cooperation with Data Management and Biostatistics Department
· Participates in blinded/unblinded data review meetings and review of clinical study report
· Performs special projects as requested by Management in the process of development of company’s service offering
· Provides medical support to Sales and Proposal Department: general medical study feasibility analysis, defining study execution assumptions.
· Contacts opinion leaders in assigned country to gather the required information for projects
Requirements:
· Medical University Degree. Preferred candidates will hold board certifications in medical oncology or being in the specialization process
· At least six years of clinical research experience
· Experience working on clinical studies, across different phases of drug development
· Experience or interest in haemato-oncology or immunology therapeutical area
· Proven organizational and analytical skills
· Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
· Knowledge of spoken and written English
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with:
- Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;
- Empowering workspace, with a flat hierarchy, offering opportunities to share ideas and influence company services development worldwide;
- Possibility of getting involved in multinational studies;
- Onboarding process to enable you fast takeover of duties and Buddy Mentor who will introduce you to the organization;
- Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;
- Additional day-off for your birthday.
Please be informed that by sending application documents containing personal data to a wider extent than required by provisions of the labor law you are granting consent for the data to be processed by KCR S.A. with its registered office in Warsaw (6 Postępu St., 02-676 Warsaw) for the purposes of the ongoing recruitment.
If you want your candidacy to be considered also for future recruitments, please send us an additional consent: “I agree to the processing of my personal data for use in future recruitments conducted by KCR S.A. with headquarters in Warsaw for a period of up to 36 months”. Such consent may be placed in a CV or electronic correspondence addressed to us.
You can withdraw your consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.
More information on the processing of personal data can be found at: https://www.kcrcro.com/privacy-policy/
