Medical Director/ Senior Medical Director
Global Clinical Development, KBP Biosciences
Why KBP Biosciences?
KBP Biosciences is a global, clinical stage biopharmaceutical company focused on the development of an innovative pipeline of new chemical entities with known mechanisms of action targeting underserved patient populations in organ protection and infectious diseases. KBP Biosciences utilizes an integrated discovery and development platform that enables the Company to efficiently bring new therapies from bench to patients around the world.
KBP Biosciences offers professionals the opportunity to face new challenges and pursue a career in a fast-growing, biotechnology driven healthcare company. At KBP Biosciences, we see opportunities for change, and we are seizing on them to make a difference in delivering life-changing medicines by being entrepreneurial. We are passionate about improving patient health by leading innovation in Renal Disease, Cardiovascular Diseases, and Infectious Disease and more. We are looking for people who share our passion and commitment to helping us achieve this goal.
The position is to provide oversight with regards to medical issues that impact the full clinical development spectrum for the assigned drug candidates. The job will include extensive involvement in the design of clinical development plans, clinical trial synopses and protocol development as well as functioning as the medical monitor for the clinical trials (including medical evaluation of adverse events and drug safety). The position will be responsible for overall successful conduct of the clinical trials including oversight of the clinical data quality and achieving the key study milestones in a timely manner. The position will work seamlessly with clinical operations, data management/statistics and regulatory as well as other groups within the organization (commercial, business development, etc.) to ensure the appropriate dispersal of information within the company and, as necessary, with external advisors.
This position will also be responsible for proper medical evaluation/interpretation of assigned clinical trials. It requires an understanding of the therapeutic context of the clinical program and is able to discuss hypotheses with experts, investigators and other hospital staff. It will play a key role in the identification of investigators and building/maintaining relationships with opinion leaders.
Essential Duties & Responsibilities:
1. Responsible for all activities as study team physician for US and global trials including design of trials, medical oversight of trial conduct, data interpretation as appropriate and execution of compassionate use approaches.
2. Actively participates in study management with the cross functional clinical team (clinical operations, data management/statistics and regulatory, etc.) to ensure the team will achieve key study milestones including timeline and ensure high data quality from the clinical studies assigned.
3. Works with Clinical and Regulatory Affairs in the preparation of project- related documents and regulatory submissions, including Investigator's Brochures, CSRs, abstracts, manuscripts, training material, Annual Reports, INDs and NDA's.
4. Responsible for medical monitoring portion of site initiation, site oversight and monitoring, on-site presentations, site close-out and especially understanding of adverse events.
5. Medical review of individual case safety reports, serious adverse event reports and clinical outcome reports
6. Assists with execution of clinical studies to establish the safety, efficacy and commercial viability of new drug candidates.
7. Actively participates in site selection and assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures.
8. Assists with study vendors selection and education.
9. Provide medical consultation to team members, CROs, investigators, and staff to answer study related medical questions.
10. Provides scientific and medical/clinical advice when necessary to relevant stakeholders both internally and externally to the organization. Ensure alignment on content of effective clinical presentations provided, ensuring presentations are tailored to meet the specific needs of the audience.
11. Communicates and interacts effectively with in-house personnel, clinical sites and outside contractors/CROs.
12. Has a teaching role in investigator meetings and training of new staff.
13. Participates in the formulation of overall clinical strategy, clinical development plan and business development.
14. Identify expert sources for clinical information on compounds in the development pipeline to better inform research and development efforts.
15. Assist in publications of clinically relevant information for the investigational drug development.
16. Assist in development, implementation and maintenance of policies and procedures.
17. Supports Investigator Initiated Trial Committee.
18. Supports scientific congress attendance via pre-meeting planning and post-meeting reporting.
Education and Experience:
• M.D., D.O., PharmD, or equivalent from an accredited college or university.
• At least 3-5 years clinical research experience in the U.S. biotech/pharmaceutical industry. Experiences in renal, cardiovascular and infectious disease are preferred but not required.
Knowledge, Skills, and Abilities:
• Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development regulations and processes.
• Experience/in depth understanding of clinical trial/drug development.
• Excellent written and oral English communication and presentation skills and interpersonal skills to engage internal and external leaders proactively.
• Proven ability to work effectively on a team in an entrepreneurial environment.
• Ability to develop and maintain an in-depth understanding of disease states, product knowledge, product labeling, and relevant data to apply to daily job function.
• Must be able to quickly and adeptly spot patterns in questions and feed them back to the clinical, commercial, and medical affairs staff.
• Convey a professional attitude, demonstrate attention to detail, and possess flexibility and self-motivation.
• Travel for conferences, meetings, and other needs to support the organization.
Director for Regulatory Affairs
Director of Regulatory Affair will provide leadership in the evaluation, development, implementation, and management regulatory strategy. The individual in this role will be part of R&D and other important areas. This position requires a critical and stratigic thinker who has previous experience and will offer opportunities to help drive key decision-making activities within the Company.
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
Educational Requirements: MS or PhD
Professional Work Experience
A minimum of 10 years of relevant experience in US regulatory affairs/drug development
Experience in the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company objectives
Keeps abreast of US regulatory procedures and changes
Assists with planning interactions with regulatory agencies in US, EU, Asia
Extensive regulatory agency interactions and filing experience
Extensive expertise with regulatory related development procedures (e.g., scientific advice, orphan designation, paediatric development plans, fast track, breakthrough).
Global experience and/or knowledge of ICH regulations
Ability to work independently is very important.
Excellent communication skill
Director of Project Manager
Serves as the leader and coordinator for implementation of clinical trial activities and management of the clinical trial(s), from study start up through to CSR completion;
Assist in development operational strategy (including ancillary vendors) for clinical studies;
Manage CROs and external vendors to ensure studies are conducted to according to project plan and ICH guideline;
Ensure studies are completed on budget;
Lead risk assessment, develop contingency planning and risk-mitigation strategies at the project level
Approximately 6-8 years of project management experience, preferably with a sponsor company (CRO experience a plus) managing outsourced global Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20%-30% potential travel, adjusted as necessary for COVID-19).
clinical trials within quality, timeline, and budget expectations.
Prior investigator site and/or monitoring experience is advantageous
Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.
Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
Ability to establish operational plans and support the CRO in the execution of the plans.
Requires a balance of scientific and operational/project management and team leadership expertise.
Must be able to build effective relationships across and up and down the organization.
Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20%-30% potential travel, adjusted as necessary for COVID-19).
B.A. or B.Sc. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills.