Medical Director, Clinical Development

ExtensisHR•Falls Church, VA

About The Position

The Medical Director provides medical and scientific leadership for assigned clinical development programs at Retension Pharmaceuticals, including RTN-001, under the direction of the SVP, Clinical Development. This hands-on role partners with cross-functional teams to design and execute patient-centered clinical trials, provide medical oversight, and support patient safety, scientific rigor, and regulatory compliance. The role leads medical input into assigned cardiovascular clinical trials, including their design, execution, medical monitoring, and interpretation. It provides oversight of safety, efficacy, and cardiovascular endpoints; supports clinical development strategy; reviews study and regulatory documents; and guides investigators and sites during study start-up and execution. The Medical Director also contributes to regulatory support, pharmacovigilance, external scientific engagement, publications, and cross-functional planning.

Requirements

MD, DO, or equivalent medical degree required.
At least 7 years of pharmaceutical, biotechnology, clinical research, or academic medicine experience, preferably in cardiovascular, cardiometabolic, hypertension, renal, or related areas.
Experience in pharmaceutical or biotechnology clinical development, including hands-on medical monitoring and cross-functional study team collaboration.
Strong knowledge of drug development, GCP, clinical trial conduct, and pharmaceutical regulations.
Strong knowledge of clinical research, cardiovascular medicine, hypertension, pharmacovigilance, and regulatory requirements.
Excellent scientific, clinical data interpretation, written, verbal, and presentation skills.
Strong command of clinical trial design, endpoints, statistics, safety assessment, dose selection, benefit-risk evaluation, and drug-development principles.
Ability to communicate complex medical information clearly to internal and external stakeholders.
Strong leadership, collaboration, judgment, and project management skills in a fast-moving clinical-stage environment.
Comfort operating in a small, fast-paced clinical-stage biotechnology environment with a hands-on, collaborative approach.

Nice To Haves

Board certification in a relevant specialty.
Experience with Phase 2 or later clinical trials, investigator engagement, and clinical data review.
Experience contributing to regulatory submissions.
Board certification or advanced training in cardiology, internal medicine, nephrology, hypertension, vascular medicine, or a related specialty.
Experience with antihypertensive drug development, cardiovascular therapeutics, PDE5 biology, nitric oxide signaling, or vascular physiology.
Experience providing medical leadership within cross-functional study teams in a small or growing biotechnology company.
Experience with FDA or other health authority interactions, publications, or scientific contributions in relevant research areas.

Responsibilities

Serve as medical and scientific lead for assigned cardiovascular clinical development studies, including RTN-001.
Partner with Clinical Operations and cross-functional teams to support scientific rigor, patient safety, regulatory alignment, and timely execution of assigned studies.
Monitor scientific literature, treatment guidelines, and competitive trends to inform development decisions.
Lead medical input into the design, execution, medical monitoring, and interpretation of assigned clinical trials in collaboration with Clinical Operations, Biostatistics, and other functions.
Review protocols, investigator brochures, informed consent forms, study reports, safety narratives, and other key study documents.
Provide medical oversight of safety, efficacy, and cardiovascular endpoints, and contribute to clinical development strategy for RTN-001 and future programs.
Provide medical and scientific guidance during study start-up and execution, including investigator and site assessment, site initiation, investigator engagement, enrollment support, protocol interpretation, and review of study conduct.
Escalate significant medical or safety issues to the SVP, Clinical Development and appropriate cross-functional teams.
Participate in advisory boards, congresses, investigator meetings, and educational programs.
Partner with Regulatory Affairs on submissions, labeling strategy, health authority interactions, and responses to regulatory questions.
Provide medical input on clinical trial applications, amendments, safety updates, briefing materials, and related documents.
Ensure assigned medical activities comply with applicable regulatory requirements and FDA, ICH, and GCP guidelines, in collaboration with Regulatory Affairs and Quality.
Review and assess adverse event reports and safety signals; participate in safety review committees and risk management activities.
Support benefit-risk evaluations and product safety monitoring activities.
Build relationships with external experts, investigators, academic institutions, professional societies, and clinical trial sites.
Present and discuss scientific and clinical data at professional forums as indicated.
Contribute medical and scientific input to publication planning, congress strategy, and scientific communications in collaboration with cross-functional teams and clinical development leadership.
Collaborate with internal teams and executive leadership to align clinical objectives, priorities, and timelines.
Collaborate with investigators, clinical research organizations, and other external partners on medical and scientific activities for assigned studies.
Serve as a medical and scientific resource to internal and external stakeholders.
Provide medical and scientific input to business development, investor communications, and strategic planning activities as requested by clinical development leadership.