Position:
- Medical Director/Senior Medical Director, Global Clinical Development
Therapeutic Areas:
- Uric Acid Metabolism
- Inflammatory Pain
- Gout Metabolic Syndrome
- Rheumatology
- Renal/Nephrology
- Cardiovascular
Experience Preferences:
- M.D., D.O., PhD, 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 rheumatology or renal/cardiovascular are preferred but not required
Ideal Skills:
- 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.
Responsibilities:
- 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.
- 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.
- 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.
- Responsible for medical monitoring portion of site initiation, site oversight and monitoring, on-site presentations, site close-out and especially understanding of adverse events.
- Medical review of individual case safety reports, serious adverse event reports and clinical outcome reports
- Assists with execution of clinical studies to establish the safety, efficacy and commercial viability of new drug candidates.
- 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.
- Assists with study vendors selection and education.
- Provide medical consultation to team members, CROs, investigators, and staff to answer study related medical questions.
- 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.
- Communicates and interacts effectively with in-house personnel, clinical sites and outside contractors/CROs.
- Has a teaching role in investigator meetings and training of new staff.
- Participates in the formulation of overall clinical strategy, clinical development plan and business development.
- Identify expert sources for clinical information on compounds in the development pipeline to better inform research and development efforts.
- Assist in publications of clinically relevant information for the investigational drug development.
- Assist in development, implementation and maintenance of policies and procedures.
- Supports Investigator Initiated Trial Committee.
- Supports scientific congress attendance via pre-meeting planning and post-meeting reporting.
Summary:
- 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
