For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Executive Medical Director, Medical Services
Essential Functions:
Drive the development and growth of the medical services department, actively participating in interviewing activities and making hiring decisions for medical consultants and full-time medical department staff, in collaboration with Talent Acquisition.
Oversee medical monitors, clinical medical director, clinical safety monitors, clinical scientists and other team members and conducts regular performance evaluations, provides ongoing mentoring and training to support professional development.
Track key performance indicators (KPIs) to measure operational performance.
Develop and oversee the implementation of policies and standard operating procedures for the medical department, resulting in enhanced efficiency and productivity.
Evaluate and identify staffing requirements for awarded clinical studies based on project and client needs.
Monitor medical department performance against forecast and budget goals.
Lead medical client alignment discussions upon clinical study award.
Oversee the management of medical monitoring activities during clinical trials and projects, including development of Medical Monitoring Plan.
Act as liaison for investigators and monitors regarding study-related medical / safety issues and resolution of study protocol and patient eligibility issues, per contract deliverables.
Provide and / or oversee medical review of key clinical documents, Individual Case Safety Reports, and medical or safety-related regulatory documents.
Provide support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
May present topline results to Sponsors or Competent Authorities.
May support Medical Affairs activities, as requested.
May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities.
Train project team on therapeutic indication and / or treatment modality.
May assist in safety case processing as dictated by contract deliverables.
Oversee, review, and direct medical and safety sections of regulatory document submissions.
May participate in Investigator meetings.
Assist with RFI / RFP completion.
Attend and support sales capabilities meetings, as requested.
Develop and assist other team members in the development of internal processes, study timelines, planning, and strategy.
Facilitate collaboration and communication with medical / scientific personnel and ensure that the most current research information is accessible for review.
Supervise and manages all medical budgets for all proposals.
Other duties as assigned.
Necessary Skills and Abilities:
Good communication and strong interpersonal skills: able to liaise efficiently with client companies to ensure the client needs are met.
Able to work within a team in an open and professional manner.
Able to liaise efficiently with internal departments to facilitate delivery of services.
Sound planning, prioritizing, and organizational skills.
Excellent written and oral communication skills and computer literacy.
Must have the ability to understand and analyze complex clinical and statistical data.
High level of accuracy and attention to detail.
Ability to prioritize workload and meet deadlines.
Flexible and proactive toward changing needs.
Educational Requirements:
Medical Doctor (MD) or Doctor of Osteopathy (DO) from an accredited university.
Completion of residency training.
Certification: Preferably board certified in the US.
Experience Requirements:
Minimum of five (5) years of post-residency clinical patient experience; five (5) years of clinical research and medical / safety management experience in the pharmaceutical industry; at least 3 years in the CRO industry.
Experience in management of a team of consultant resources is required.
#LI-REMOTE
#LI-AP1
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***