Company: WCG Clinical
Job description: General Information
Location: Plymouth Meeting, PA, Remote
Organization: ACI Clinical
Job Type: Full Time - Regular
Description and Requirements
JOB SUMMARY: The Senior Medical Director will serve as a clinical and medical leader within Review Solutions with a focus on independent expert committees including Endpoint Adjudication Committees (EACs) and if needed, Data Monitoring Committee (DMCs). This role will support the delivery for assigned independent expert committee projects, accounts and tasks by providing medical leadership utilizing scientific and regulatory expertise. This position is responsible for providing strategic scientific, regulatory and medical insight to external clients and for supporting internal teams to drive business success for medical deliverables. The Senior Medical Director will collaborate with stakeholders to ensure the successful delivery of clinical-medical deliverables, including but not limited to: Regulatory Affairs, Clinical Operations, Data Management, Biostatistics, executive leaders, Adjudication or Data Monitoring Committee Members, study Investigators and their staff, CROs and Vendors.
EDUCATION REQUIREMENTS:
- An advanced degree or combination of degrees (PhD, MD, MPH, PharmD) from accredited institutions with prior experience in medical research with a focus on clinical research or equivalent combination of education and experience
- Medical board certification.
- Minimum of six years of experience in the clinical research industry required; experience working for a biopharmaceutical sponsor or a clinical research organization preferred
- Minimum 3 years of experience as a Medical Director and/or clinical trial science lead or similar role, with external-facing responsibilities managing the clinical / medical aspects of a clinical trial, with demonstrated ability to leverage scientific concepts to influence external audiences and/or clients required
- Demonstrated ability to work in a fast-paced environment in a growing organization leading a wide range of clinical-medical activities for clinical adjudication, data monitoring or other assigned services
- Experience reviewing or analyzing medical safety and efficacy data
- Experience working in cross-functional team environments, including working with key opinion leaders
- Experience in one or more of the following areas is desirable: Cardiology, Oncology, Immunology, Infectious Disease, and Gastroenterology
- Experience building strong collaborative relationships and networks
- Ability to adjust priorities based on agile environment
- Strong communication, negotiation and influence skills across audiences, demonstrated by ability to assess complex situations, devise impact-generating solutions based on incomplete data and the ability to present complex information in a simplified way is required
- Demonstrated leadership skills and ability to integrate in a team, motivate others, provide coaching and communicate clearly and effectively
- Strong problem solving/decision making skills demonstrated by ability for independent critical thinking, solution generation and engagement in active scientific exchange
- Expert knowledge of Good Clinical Practice (GCP)
- Fluency in English required
- Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools
- Demonstrates a high level of expertise in clinical research and protocol / study design to serve as point-of-reference (internal and external) for assisting with medical project delivery challenges, clinical escalations, or deliverables and for solving problems
- Applies a strategic mindset, deep understanding of processes, along with the ability to be a proficient communicator and leader
- Provides medical guidance or selection on committee member selection, when necessary
- Contributes to the development and growth of the committee member database, as needed.
- Manages, trains, and evaluates medical consultant staff, when necessary.
- Provide business development support through review of proposals and potential opportunities, as well as participating in capabilities and bid defense presentations.
- Provides clinical-medical leadership to the EAC business, including authoring, review or approval of the following key deliverables:
- The development of the EAC Charter and approval/authoring of Charter definitions
- EAC member selection
- Event identification strategy
- Patient profile requirements
- Voting & Decision Form design
- Attendance at strategy meetings, building relationships with accounts, active participation in client-facing clinical-medical interactions to ensure scientific and operational success of WCG projects
- Performs medical review of patient events utilizing relevant data including but not limited to: adverse and serious adverse event data, laboratory data, and other relevant medical data
- Performs medical review, as needed, of adjudication data including but not limited to source records, patient profile, laboratory listings, individual voting records, decision results, listings
- Attendance during key meetings with the Sponsor, Vendor, EAC or medical consultants, serving as a bridge between EAC Operations staff and external medical contacts. Serve as point of escalation for clinical-medical issues that impact projects and programs
- Collaborates with functional team leads to ensure the proper service execution
- Provides expert clinical-medical support, leveraging strong communication and negotiation skills and strategies
- Own medical responsibility on projects ensuring the scientific integrity, proper escalation and remediation of project-specific challenges is executed and effectively communicated
- Conduct clinical training for functional departments, specifically the clinical specialists.
- Proactively identify and support resolution of project and account related risks as assigned, through active communication across departments and adherence to policy/procedure. Resolve and communicate quality events promptly and effectively
- Authors or reviews whitepapers, abstracts, presentations, and other materials as a thought-leader for independent expert committees, representing WCG
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here
- Attendance and punctuality are essential functions of the position
TRAVEL REQUIREMENTS: This role may require up 20% travel which may be domestic or international, including overnight and weekend stays, consistent with project needs and office location.
WHY WE LOVE WCG: At WCG, our employees are our most valuable asset and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health and to help them make the most of their future.
- Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
- Employee Assistance Programs and additional work/life resources
- Referral Bonuses and Tuition Reimbursement
- Paid time off including holidays, vacation, and sick time
- Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement
GPS Level: P6
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WCG is proud to be an equal opportunity employer - Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law.
Expected salary:
Location: Plymouth Meeting, PA Apply Now