Hiring.Camp

Medical Director, Clinical Development

Extensishr

·

Yesterday

Salary
$245k – $320k
Location
Falls Church, VA, US
Department
Healthcare
Seniority
Director
Education
Master
Closing date
Today
Source
iCIMS

Description

Who We Are

We are a clinical-stage biopharmaceutical company focused on developing medicines for the treatment of hypertension and other cardiovascular diseases. Our product candidate, RTN-001, is a next-generation, once-daily, oral, small molecule phosphodiesterase-5 (PDE-5) inhibitor designed to reduce blood pressure by potentiating nitric oxide signaling, a key mechanism underlying the development and severity of hypertension.

Who You Are

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.

What You'll Do

Medical Leadership • Serve as the medical and scientific lead for assigned cardiovascular clinical development studies, including RTN-001. • Partner with Clinical Operations and other 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.

Clinical Development • 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 key study documents, including protocols, investigator brochures, informed consent forms, study reports, and safety narratives. • Provide medical oversight of safety, efficacy, and cardiovascular endpoints for assigned studies, 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. Regulatory & Compliance Support • 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.

 

Pharmacovigilance & Safety • Provide medical review and assessment of adverse event reports and safety signals. • Participate in safety review committees and risk management activities. • Support benefit-risk evaluations and product safety monitoring activities.

External Scientific Engagement • 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.

 

Cross-Functional Collaboration • Collaborate with internal teams and executive leadership to align on 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 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.

What You Bring

Education • MD, DO, or equivalent medical degree required. • Board certification in a relevant specialty preferred.

 

Experience • 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. • Experience with Phase 2 or later clinical trials, investigator engagement, and clinical data review; experience contributing to regulatory submissions preferred. • Strong knowledge of drug development, GCP, clinical trial conduct, and pharmaceutical regulations.

 

Knowledge, Skills, and Abilities • 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. • Comfortable operating in a small, fast-paced clinical-stage biotechnology environment with a hands-on, collaborative approach.

 

Preferred Qualifications • Board certification or advanced training in cardiology, internal medicine, nephrology, hypertension, vascular medicine, or 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.

What We Offer

Compensation The salary range for this position is $245,000 to $320,000 per year. Competitive compensation package includes base salary, annual performance bonus, long-term incentive/equity opportunities, and comprehensive benefits package.

 

 

#INDMM

Skills

GCPClinical TrialsFDARisk ManagementComplianceProject ManagementStrategic Planning

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