Primary Responsibilities
This position is primarily responsible for providing oversight and management of all medically relevant activities in clinical development, pharmacovigilance and drug safety oversight. Will participate in the planning, execution, interpretation and communication of upcoming US and ex-US clinical trials. Provides medical direction for the ongoing development and implementation of the worldwide clinical strategy for all products and pipeline. Will also provide input to the marketing team regarding communications between the Company and physicians, allied medical professionals, and patients.
Job Responsibilities
- Working with the clinical development team, provide guidance in the planning, design, implementation and monitoring of phase 1-4 clinical trials for marketed products and new formulations. Working closely with the Research & Development and Regulatory teams to ensure effective clinical trial strategy, design, execution, and ultimately regulatory submission. Monitor ongoing clinical trials including safety evaluations (adverse events and lab abnormalities) at regular intervals and present blinded safety results of Phase 2 and 3 trials to data safety monitoring board. This includes establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Assist with study design and protocols for future trials that will support currently marketed brands, working with R&D to implement approved protocols. Serve as medical monitor of a clinical program.
- Participate in the initial and ongoing training for Sucampo and CRO staff (CRAs and medical monitors) especially as it relates to safety monitoring and reporting for Company protocols. Coordinate and provide medical training, including disease/protocol-specific, safety regulations, or therapeutic area presentations for clinical staff, project teams and/or investigator meetings.
- Interpret data from clinical trials, including outcomes and findings, leading to recommendations on clinical development and regulatory filing strategies. Review final clinical study reports, including final data tables and safety discussion sections, for regulatory submission.
- Coordinate with Regulatory Affairs on preparation of clinical regulatory submissions to FDA and international regulatory agencies for INDs, protocols, investigator brochures, serious adverse events, end of phase 1 and 2 discussions and BLA submissions.
- Provide medical monitoring for clinical studies (e.g. inclusion and exclusion criteria, protocol procedure clarifications and waivers), as well as provide medical oversight for serious adverse event reporting and tracking, and communication of safety issues to staff, sponsors, and regulatory authorities; oversee and provide consultation for lab report review, CRF safety review, and potential endpoint reporting for clinical projects.
- Develop safety monitoring and reporting plans for clinical studies and ensure quality of medical program deliverables in accordance with quality assurance project plans and standards.
- Manage risk management plans including product labeling issues, all communications to regulatory agencies, serve as liaison for product safety to external committees including Data Monitoring Committees. Communicate effectively and efficiently on safety and benefit, ensuring consistency in safety reporting and strategy for FDA communications and meetings, liaise with key opinion leaders, and represent Sucampo at FDA meetings covering safety issues (e.g. pre-IND, end of Phase 2, pre-NDA, and label negotiation meetings).
- Ensure that all safety database training and quality control procedures are being followed and updated regularly by the relevant departments and make recommendations if not. Assist in development of strategic marketing plans and publications for developing products and collaborate with strategic marketing to identify target profiles for all Sucampo products.
The duties listed above are intended to describe the general content of and requirements for the performance of this position. It does not represent an exhaustive list of duties, responsibilities, and requirements.
Job Qualifications
- M.D. degree; board certified
- Specialization in internal medicine strongly preferred with an understanding of care for geriatric patients.
- Several years experience in drug safety and pharmacovilance
- At least two years experience in a pharmaceutical clinical development environment responsible for writing clinical protocols, initiating studies, managing/monitoring clinical trials, and writing clinical technical reports. Solid knowledge of FDA regulatory requirements and prior drug development industry experience are both required
- Demonstrated experience in successfully leading clinical development of drug candidates from pre-clinical activities through clinical trials and successful product approval(s)
- Demonstrated ability to work collaboratively with, influence, and impart scientific information to, persons from a broad cross-section of academic, research, medical backgrounds.
- Experience writing grants, publications and proposals, or other pharmaceutical documents is required.
- Strong interpersonal skills and ability to manage, motivate and influence work behaviors of individuals who are not direct reports.
- Must be able to communicate effectively regarding clinical data, and issues related to reimbursement and Health Economic and Outcomes research.
- Demonstrated expertise in managing complex collaborations and teams in support of executing clinical trials effectively, including effective management of projects and timelines and interpretation/evaluation of clinical data
- Must be knowledgeable with FDA requirements, good clinical practices, and pharmaceutical clinical development
- Highly organized, outcome oriented, leadership and problem solving, understanding of research methods and basic data analysis, excellent management, team process, strong communication skills, clinical study design experience, current in clinical knowledge.
- Excellent written and verbal communication skills
Benefits
- Paid vacation
- Health & Dental Insurance on 1st day of employment
- 12 paid holidays
- Paid Parking or Metrocheks/Smartpass (we are 2 blocks from the Bethesda, Metro)
- Flexible Spending Plan
- Business Casual dress everyday
- Company paid Life Insurance
- Company Paid Long Term Disability & ADD Insurance
- Employee Assistance program
- 401k with generous employer match
To Apply
Send your resume (MS Word or RTF) and salary requirements to sbach@sucampo.com. Please reference job code MD-080508-S in the subject line of your email to ensure proper routing of your resume. Resumes sent without salary requirements will not be considered.
Principals Only!
Sucampo Pharmaceuticals, Inc. is an equal opportunity employer. EOE/M/F/D/V
