Vivid Resourcing
Medical Director - Clinical Development
Vivid Resourcing, Raleigh, North Carolina, United States, 27601
Overview
Medical Director, Clinical Development
role based in Raleigh-Durham, NC. On-site 4 days per week. Full-Time, Permanent. Our client is an innovative
SME biotechnology company
focused on developing
novel immunology therapies
that address serious unmet medical needs. With a pipeline at Phase I/II development, the company is advancing first-in-class and best-in-class candidates across multiple immune-mediated and inflammatory diseases. Backed by strong science and an experienced leadership team, they are seeking a
Medical Director, Clinical Development
to help drive their clinical programs forward and contribute to their growth story. Responsibilities
As Medical Director, you will be the
medical lead
on early-stage clinical programs and play a central role in the design, execution, and interpretation of clinical trials. Your responsibilities will include: Clinical Strategy & Trial Leadership
Lead the medical strategy for one or more clinical assets within the immunology portfolio (Phase I/II). Provide scientific and medical input into clinical development plans (CDPs) and long-term portfolio strategy. Serve as medical monitor for clinical trials, overseeing patient safety, eligibility, dosing, and adverse event management. Protocol & Study Design
Draft, review, and approve study protocols, Investigators Brochures (IB), and related clinical documents. Collaborate with clinical operations and external investigators to ensure trial feasibility and optimal study design. Contribute to endpoint selection, biomarker strategy, and translational science integration. Cross-functional Collaboration
Partner with regulatory affairs on IND/CTA submissions, clinical trial applications, and agency interactions. Collaborate with biostatistics and data management to ensure rigorous trial design and data analysis. Work with pharmacovigilance teams to ensure robust safety monitoring and reporting. External Engagement
Act as a company representative with clinical investigators, KOLs, scientific advisors, and regulatory authorities. Present study updates and data at scientific meetings, advisory boards, and conferences. Qualifications
MD (or equivalent medical degree) required; specialization or strong background in
immunology, rheumatology, dermatology, gastroenterology, or related fields
preferred. 35+ years of experience in
clinical development
within the pharmaceutical/biotech industry (early development experience highly valued). Strong understanding of early-phase (Phase I/II) trial design, dose escalation, and safety monitoring. Experience drafting and reviewing clinical protocols, IBs, and regulatory submissions. Proven ability to interpret clinical data and communicate effectively to internal teams and external stakeholders. Excellent communication, leadership, and cross-functional collaboration skills. Must be willing to work
on-site in Raleigh-Durham 4 days per week
(local candidates strongly preferred). Whats on Offer
Unique opportunity to help shape the clinical development of a
Phase I/II immunology pipeline
at a growing SME. Collaborative and entrepreneurial biotech environment with strong leadership and scientific backing. A role with direct impact on advancing therapies for patients with serious immune-mediated diseases. Please apply directly here or contact me on joel.isaac@vividresourcing.com if you have any questions. Seniority level
Director Employment type
Full-time Job function
Science Industries
Pharmaceutical Manufacturing and Medical Practices
#J-18808-Ljbffr
Medical Director, Clinical Development
role based in Raleigh-Durham, NC. On-site 4 days per week. Full-Time, Permanent. Our client is an innovative
SME biotechnology company
focused on developing
novel immunology therapies
that address serious unmet medical needs. With a pipeline at Phase I/II development, the company is advancing first-in-class and best-in-class candidates across multiple immune-mediated and inflammatory diseases. Backed by strong science and an experienced leadership team, they are seeking a
Medical Director, Clinical Development
to help drive their clinical programs forward and contribute to their growth story. Responsibilities
As Medical Director, you will be the
medical lead
on early-stage clinical programs and play a central role in the design, execution, and interpretation of clinical trials. Your responsibilities will include: Clinical Strategy & Trial Leadership
Lead the medical strategy for one or more clinical assets within the immunology portfolio (Phase I/II). Provide scientific and medical input into clinical development plans (CDPs) and long-term portfolio strategy. Serve as medical monitor for clinical trials, overseeing patient safety, eligibility, dosing, and adverse event management. Protocol & Study Design
Draft, review, and approve study protocols, Investigators Brochures (IB), and related clinical documents. Collaborate with clinical operations and external investigators to ensure trial feasibility and optimal study design. Contribute to endpoint selection, biomarker strategy, and translational science integration. Cross-functional Collaboration
Partner with regulatory affairs on IND/CTA submissions, clinical trial applications, and agency interactions. Collaborate with biostatistics and data management to ensure rigorous trial design and data analysis. Work with pharmacovigilance teams to ensure robust safety monitoring and reporting. External Engagement
Act as a company representative with clinical investigators, KOLs, scientific advisors, and regulatory authorities. Present study updates and data at scientific meetings, advisory boards, and conferences. Qualifications
MD (or equivalent medical degree) required; specialization or strong background in
immunology, rheumatology, dermatology, gastroenterology, or related fields
preferred. 35+ years of experience in
clinical development
within the pharmaceutical/biotech industry (early development experience highly valued). Strong understanding of early-phase (Phase I/II) trial design, dose escalation, and safety monitoring. Experience drafting and reviewing clinical protocols, IBs, and regulatory submissions. Proven ability to interpret clinical data and communicate effectively to internal teams and external stakeholders. Excellent communication, leadership, and cross-functional collaboration skills. Must be willing to work
on-site in Raleigh-Durham 4 days per week
(local candidates strongly preferred). Whats on Offer
Unique opportunity to help shape the clinical development of a
Phase I/II immunology pipeline
at a growing SME. Collaborative and entrepreneurial biotech environment with strong leadership and scientific backing. A role with direct impact on advancing therapies for patients with serious immune-mediated diseases. Please apply directly here or contact me on joel.isaac@vividresourcing.com if you have any questions. Seniority level
Director Employment type
Full-time Job function
Science Industries
Pharmaceutical Manufacturing and Medical Practices
#J-18808-Ljbffr