Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Clinical Research Scientist providing scientific and clinical expertise to support product strategy at Lilly. Engaging in evidence generation and customer engagement while ensuring compliance with regulations.
Responsibilities
- Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups.
- Lead data analyses and health outcomes research to address customer questions.
- Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners.
- Provide medical expertise for payer partnerships, promotional material review, and business-to-business/government engagements.
- Support training of sales, medical, and patient support teams.
- Lead definition of Patient Journey and contribute clinical perspective to patient programs.
- Ensure compliance with global and local regulations governing scientific communication.
- Address unsolicited scientific inquiries in alignment with medical governance standards.
- Support scientific meetings, advisory boards, symposia, and other expert engagements.
- Build and maintain relationships with key opinion leaders and scientific societies.
- Participate in relevant professional and industry associations.
- Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams.
- Communicate local research needs to ensure Phase III–IV programs reflect market and customer requirements.
- Maintain up-to-date understanding of clinical and competitive data.
- Provide regional clinical insights to inform development plans and study protocols.
- Review and approve informed consent documents to ensure accurate risk communication.
- Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close-out.
- Support investigator/site training and address study-related medical questions.
- Review investigator-initiated trial (IIT) proposals as needed.
- Ensure global alignment of Phase 3b/4 and applicable early-phase studies.
- Contribute to development and review of local labeling and labeling changes.
- Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities.
- Participate in risk management planning with global and local teams.
- Stay informed on therapeutic area trends, market changes, and competitive landscape.
- Provide scientific training to clinical study teams and act as a protocol subject-matter expert.
- Set and pursue professional development goals and support growth of colleagues and direct reports.
- Contribute to recruitment, diversity, and retention efforts when applicable.
- Participate in committees, Six Sigma initiatives, and cross-functional projects.
- Model leadership behaviors and serve as an ambassador for patients and the company.
Requirements
- An advanced health/medical/scientific graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10+ years of clinical experience or pharmaceutical experience (preferably in Medical Affairs)
- Have a BS or master's degree in health/medical/scientific or related field and 10+ years of pharmaceutical experience that is directly related to at least one of the following: Clinical trial experience in areas relevant to drug discovery, Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) or direct role and contribution to medical content.
- Alzheimer’s disease therapeutic area expertise
- Global Medical Affairs experience
- Strong stakeholder management
- Effective communication
- Organizational excellence
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
- Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
- Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
- Fluent in English, verbal and written communication.
Benefits
- Eligibility to participate in a company-sponsored 401(k)
- Pension
- Vacation benefits
- Eligibility for medical, dental, vision, and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Research Coordinator overseeing clinical studies for musculoskeletal injuries in military health. Assisting with project planning and coordination while ensuring compliance with protocols and regulations.
Overseeing and administering clinical research studies and managing study budgets for military health research. Coordinating project planning and ensuring compliance with regulatory requirements.
Senior Biostatistician coordinating clinical trials at Parexel. Leading project teams and ensuring statistical quality in clinical research.
Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
Clinical Research Nurse Coordinator managing clinical research operations at Duke's Trauma, Acute & Critical Care Division. Supervising nursing care and ensuring accuracy in data management.
Clinical Research Coordinator managing clinical trials at Emory University. Overseeing research projects, providing guidance, and ensuring compliance with protocols and regulations.
Senior Clinical Trial Manager managing Phase 1 clinical research studies and collaborating with cross - functional teams in a global biopharmaceutical environment.
HR Manager for Clinical Research Units lead engagement strategies at Fortrea. Partnering closely with site leadership in clinical environments in Dallas, TX or Madison, WI.
Clinical Trial Manager overseeing clinical trials managing operations and compliance in Brazil at IQVIA. Ensuring adherence to protocols and managing country - specific requirements.