Principal Clinical Regulatory Consultant, M.D.

Position Summary:

As a Principal Consultant, you will serve as a senior leader within the organization, combining strategic insight with scientific expertise to lead complex client projects, drive business development, and mentor junior staff on your team. You will manage high-level client relationships, provide strategic U.S. Food and Drug Administration (FDA) regulatory guidance, and serve as a visible expert within your field. This role requires a demonstrated ability to independently consult, deliver strategic value to clients, and support the growth and development of the broader consulting team.

This role is a member of the Clinical Business Unit at Biologics Consulting Group, Inc. This position provides strategic and operational leadership across clinical development, clinical trial strategy, medical writing, statistical analysis, clinical pharmacology, pharmacovigilance, and regulatory support. The Principal Clinical Consultant ensures the delivery of high-quality, scientifically sound, and regulatory-compliant services to clients developing medical devices, biologics, pharmaceuticals, medical imaging, and combination products. This role focuses on ensuring clinical trials, product development, and regulatory processes align with FDA guidelines, industry standards, and best practices. The consultant provides strategic advice and technical expertise to help navigate the regulatory landscape and streamline product approval processes. This role requires deep clinical expertise, strong project management experience, and the ability to manage multidisciplinary projects in a dynamic consulting environment.

Biologics Consulting Group, Inc. works with medical devices, clinical development, biologics, and pharmaceutical companies to advance patient health.

Responsibilities:

• Regulatory Strategy and Guidance:

• Advise onthe regulatory requirements for product development, ensuring alignment with FDA guidelines and policies.
• Guideorganizations in preparing regulatory submissions to the FDA, including Investigational New Drug (IND) applications, New Drug Applications (NDA), 510(k) submissions for medical devices, and Biologics License Applications (BLA).
• Provideexpertisein the meeting of FDA regulatory expectations at all stages (Phase 1 - 3) of aproduct's clinicaldevelopment, includingtheapproval process.
• Advise onpotentially available regulatory pathways toexpeditea client's route to approval (accelerated approval, fast-track,and breakthrough therapy designation, etc.).

• Clinical Trial Design, Implementation,and Analysis:

• Collaborate with clinical teams to design and implement clinical trials that meet FDA requirements for safety, efficacy, and data integrity. Advise clients on potential uses of adaptive trial designs to improvetheefficiency of clinical trials.
• Provide input on trial protocol content, safety considerations, statistical methods of data analysis, and "approvable" endpoints to ensure trials align with regulatory standards.
• Advise onthe development of clinical trial documentation, including informed consent forms, patient recruitment strategies, and trial monitoring procedures.

• Product Development and Innovation:

• Work with cross-functional teams to help integrate clinical insights into the product development process, frominitialconcept through commercialization.
• Provide feedback on product labeling, packaging, and claims to ensure compliance with FDA regulations.
• Advise onthe development of risk management strategies, including post-market surveillance and reporting of adverse events.

• FDA Inspection Preparation and Audits:

• Provide oversight tocompanies inbothpreparing forFDA inspections and audits,as wellas respondingto FDA observations, questions, and requests foradditionaldata during theauditprocess.

• Regulatory Submissions and Reports:

• Help prepare and review key regulatory documentsrequiredfor progress in product development up to and including product approval, including INDs, clinical study reports, annual reports, Type A - D Meeting Information Packages,and NDA/BLAs.
• Ensureall submissions areaccurate, complete, and submitted within requiredtimeframes.

• Clinical Data Analysis and Interpretation:

• Advise onthe interpretation and presentation of clinical trial data to demonstrate product efficacy and safety.
• Assistin the development of clinical sections of regulatory submissions, ensuring data is presented in a way that aligns with FDA expectations.

• Risk Management and Compliance:

• Provide guidance onidentifying, assessing, and mitigating risks associated with clinical trials, regulatory submissions, and product development.
• Advise onFDA-compliant strategies for adverse event reporting, labeling, and post-market monitoring.

• Training and Education:

• Educate internal teams (such as clinical researchers, regulatory affairs professionals, and product managers) on FDA requirements, regulatory changes, and industry best practices.
• Develop training materials on navigating FDA regulations, clinical trial designs, and the approval process.

• Ongoing Regulatory Monitoring:

• Keep clients updated on changes in FDA regulations, guidance documents, and industry standards.
• Advise onthe implications of new FDA policies and help clients adapt their product development strategies accordingly.

Requirements:
• M.D., or D.O. in a relevant scientific or medical discipline required
• Minimum of 10+ years of experience in clinical development, including roles in consulting, industry, or regulatory agencies requiring the use and development of advanced project management skills; experience in clinical practice or clinical trials, with a deep understanding of FDA regulatory processes, clinical trial design, and product development.
• Proven expertise and expert knowledge in clinical trial design, including the ability to design and evaluate clinical trials, trial protocols, endpoints, and data collection strategies; protocol development; and regulatory strategy
• Strong understanding of FDA regulations, global clinical development standards, and submission processes. Support includes the preparation, review, and management of regulatory applications for CBER, CDER, and CDRH.
• Proven track record of business development and client engagement, including escalation and resolution skills.
• Possess an intuition for the needs of the client and the ability to adjust to those needs.
• Deep knowledge of regulatory pathways and FDA processes.
• Experience overseeing complex client engagements to include strong project management skills, including the ability to manage timelines, resources, and cross-functional teams.
• Excellent scientific writing, analytical, and communication skills; ability to effectively communicate verbally and in writing for regulatory document preparation and client presentations.
• Demonstrated versatility in conflict resolution, problem-solving, and working effectively as part of a multidisciplinary organization.
• Effectively delegate tasks to team members.
• Skilled in interpersonal interactions within teams, including the ability to challenge other experts when deemed necessary.
• Flexibility to work across different clinical indications and therapy areas.
• Exceptional mentoring and staff development capabilities.
• Ability to create effective PowerPoint presentations and leverage current software and tools.

Key Performance Indicators:
• Quality and timeliness of clinical deliverables and client submissions
• Compliance with regulatory and ethical standards
• Achievement of individual sales and billable targets
• Contribution to team revenue and overall business development
• Strength of client relationships and client satisfaction
• Mentorship and development of junior and mid-level consulting staff
• Delivery of high-quality client work and successful regulatory outcomes
• Leadership and participation in internal and external thought leadership initiatives

Essential Skills:

Proficient in Microsoft Office Suite and clinical documentation tools, strong documentation and analytical skills, diplomacy, leadership, and project management abilities, professionalism, time management, multi-tasking, discretion and confidentiality, and ability to work independently as well as collaboratively across teams.

The listed requirements are representative of the knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.