- Assist in the overall management, planning, evaluation and documentation of programs and clinical studies
- Oversee the safety aspects of assigned clinical trials; including adverse events, safety reporting and laboratory testing in consultation with the Medical Safety physician.
- Serve as the Medical Monitor contact in study protocols
- Provide 24/7 Medical Monitor coverage
- Review and address all medical alerts in assigned studies
- Review clinical laboratory data on selected studies for safety trends or signals
- Assist clinical data management with MedDRA and WHO DD coding
- Conduct the medical reviews of safety listings and clinical trial data in assigned studies in collaboration with Medical Safety physician
- Assist by reviewing or writing clinical trial report and in collaboration with Medical Safety other safety reports including post marketing reports (e.g. PSUR)
- Review investigational brochures, protocols or other study-related documents for accuracy, completeness and comprehension and provide scientific input as needed
- Assist in the set up and conduct of Data Safety bodies (DSMB, DMB or similar) as required
- Assist with protocol interpretation and as needed, contact others to ensure appropriateness of decisions arising from such interpretation
- Provide ongoing vigilance and regular reviews of data integrity and quality from ongoing studies
- May advise and assist product development, study designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Kiniksa
- With the support of regional experts, advise on federal and local laws, regulations or medical practices affecting the clinical trials managed by Kiniksa
- May provide therapeutic consultation in support of the scientific, medical, and regulatory operations of the company
- Attend and participate in investigators' meeting and other committees' meetings as requested
- Attend and present at major therapeutic and drug development conferences
- Prepare and deliver various medical/scientific and therapeutic area training
- Requires an M.D. or equivalent with training in Rheumatology with a minimum of 5 years' experience in clinical research
- Previous work experience in biologics drug development and late clinical stage development preferred
- Able to independently make medical decisions for the study on behalf of Clinical leadership and can act as primary Medical Monitor on studies
- High level of interpersonal and presentation skills
- High integrity, get-it-done-roll-up-your-sleeves attitude and committed to putting patients first
- Experience working effectively in a fast-paced, team-based environment
- Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
- Strong verbal communication and technical writing skills
- Confidence in presenting at internal and external strategy meetings
- Salary is commensurate with experience
- Kiniksa Benefits Summary - USA
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Director, Clinical R&D - Lexington, United States - Kiniksa Pharmaceutical
Description
Reporting to the VP, Clinical Research and Development, the Director, Clinical R&D will work with a cross-functional team to ensure the medical/clinical integrity and quality of studies conducted by Kiniksa Pharmaceuticals.
This individual will ensure studies are conducted in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP).
This role will serve as the Medical Monitor contact in study protocols to investigators and study sites team regarding protocol compliance issues, data monitoring, and safety of the subjects enrolled.
The Medical Monitor will advise and assure investigators, project teams, and clients on safety issues arising from medicinal products, devices and study designs undertaken by Kiniksa.
The Medical Monitor will work with internal team members, senior management and business development on issues and questions of any medical /clinical nature.
This role will oversee developing and implementing study medical monitoring and in collaboration with the Medical Safety assess risk of Kiniksa products in clinical trials.
This person will ensure that protocols, investigator's brochures, clinical trial reports written by Kiniksa are appropriately reviewed and approved in accordance with SOPs and good medical practices.
This individual will be a key member and collaborate with the other functional program team members in developing the integrated long-range strategic plans for the program, including but not limited to plans for transition from research to First-In-Human and then early development phase(s) to late development phase(s) and approval(s)/launch(s).
For commercialized programs responsibilities include Life-Cycle-Management of clinical development projects including resolution and full registration, label expansion or additional indications as necessary.
This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities (including, but not limited to):
Qualifications:
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
