Vice President, Medical Affairs

🕒 August 6

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cristcot

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

💰 $10.5M Venture Round - Cristcot on 2025-06

Healthcare • Manufacturing • Pharmaceuticals

Cristcot is a pharmaceutical development and research company specializing in innovative drug formulations and unobtrusive drug-device combination technologies designed to improve patient adherence, reduce treatment burden, and integrate therapies into daily life. Founded in 2008 and headquartered in Austin, Texas, Cristcot provides clinical research design and execution, novel formulation and delivery engineering, specialized assay development, and regulatory strategy support; its lead investigational therapy has completed a pivotal Phase 3 study. The company focuses on solving overlooked barriers in disease management by creating intuitive, cost-effective solutions that enable more effective and confident care.

📋 Description

• Build and lead Cristcot’s Medical Affairs organization from the ground up through pre-approval readiness, launch, and post-launch expansion • Define the medical strategy and scientific narrative for Cristcot’s hydrocortisone acetate rectal suppository co-packaged with the Sephure applicator for ulcerative colitis • Establish operating infrastructure, including SOPs, governance committees, systems, and agency partnerships • Support cross-functional corporate, clinical, commercial, and regulatory teams • Establish strategic partnerships with KOLs, medical societies, healthcare institutions, payers, and patient advocacy groups • Lead participation in congresses and seminars and deliver scientific presentations to HCPs • Oversee medical training and compliance programs • Analyze HEOR activities and maintain competitive intelligence and scientific trend awareness • Continually improve the Medical Affairs Quality Management System and SOPs • Ensure compliance with FDA regulations, PhRMA Code, OIG guidance, Sunshine Act/Open Payments, GPP 2022, ACCME standards, and company policies • Develop and execute the Medical Affairs launch plan and readiness milestones with go/no-go criteria • Hire, train, certify, and deploy the field medical team ahead of approval • Lead disease-state and scientific education, including drug administration technique and clinical rationale • Deliver the scientific evidence package supporting formulary review, coverage, and guideline consideration • Select and manage medical communications, medical information, HEOR/RWE, publications, congress, and field medical technology vendors • Own the Medical Affairs operating budget and phased hiring plan • Serve as senior medical signatory in promotional and medical-legal review and establish medical governance forums • Partner with Safety/Pharmacovigilance on signal detection, adverse event reporting, and risk communication • Maintain separation between medical and commercial activities and independently escalate scientific integrity concerns • Collaborate with C-level executives and serve as the medical voice to the executive team and Board

🎯 Requirements

• Advanced degree in a clinical or scientific discipline (MD, DO, PharmD, or PhD) • 12+ years of progressive medical affairs experience in biopharma • 5+ years leading a Medical Affairs function or major sub-function with direct people and budget accountability • Record of building and scaling medical affairs teams • At least one U.S. product launch in a Medical Affairs leadership capacity, from pre-approval readiness through commercialization • Experience building an MSL team, including territory design, hiring, training, certification, field metrics, and CRM/insights infrastructure • Working command of medical information operations, publication planning under GPP, and evidence generation spanning RWE and HEOR • Experience in a small or emerging biopharma environment and willingness to operate as a player-coach • Preferred: direct experience in inflammatory bowel disease, gastroenterology, or immunology • Preferred: experience with drug-device combination products • Preferred: experience with 505(b)(2) products or other non-NME approval pathways • Preferred: experience supporting payer scientific exchange, AMCP dossier development, and pre-approval information exchange • Deep working knowledge of the U.S. healthcare system, payer decision-making, and HEOR activities • Thorough knowledge of regulatory and compliance standards • Excellent written and oral communication skills • Willingness to travel approximately 30–40% domestically