Job Summary:  

Cristcot is preparing to bring its first product to market: a hydrocortisone acetate (HCA) rectal suppository co-packaged with the Sephure applicator, developed under a 505(b)(2) pathway for ulcerative colitis. The Vice President, Medical Affairs will build the Medical Affairs function from the ground up and lead it through pre-approval readiness, launch, and post-launch expansion.

This is a builders role. The Vice President of Medical Affairs will define the medical strategy and scientific narrative for the product and the disease state, stand up the operating infrastructure (SOPs, governance committees, systems, and agency partners), hire and lead a national field medical team, and serve as the companys senior scientific voice to clinicians, payers, professional societies, and patient organizations. The Vice President of Medical Affairs is accountable for ensuring that every scientific communication Cristcot makes is accurate, balanced, non-promotional, and compliant, and that the medical organization operates with demonstrable independence from commercial objectives.

The successful candidate will bring deep inflammatory bowel disease (IBD) or gastroenterology expertise, at least one U.S. product launch, and the pragmatism to operate in a small, resource-conscious organization where the leader is also an individual contributor.

Primary Relationships:

• Within the company, the Vice President of Medical Affairs will collaborate closely with C-level executives, commercial, market access, clinical, and regulatory teams to drive launch and pipeline strategies. Partners with safety/pharmacovigilance, quality, legal, and compliance, and serves as the medical voice to the executive team and Board.
  
  
• Outside the company, the Vice President will build strategic relationships with HCPs, key opinion leaders (KOLs), medical societies, patient advocacy groups, and vendors. External relationships also include payers, PBMs and integrated delivery networks, investigators, and the medical communications, HEOR, and publications agency partners supporting the function.

Primary Job Responsibilities:

The Vice President of Medical Affairs will build and lead the medical affairs organization, overseeing medical training and compliance to support Cristcot’s products. Key assignment of the role will be to foster strategic partnerships with KOLs, healthcare institutions and practices, payers, and patient advocacy groups for positioning the value of Cristcot’s products while meeting regulatory standards.

The Activities of the Vice President of Medical Affairs will include, but are not limited to:

• Build and lead the medical affairs organization to support cross-functional teams (corporate, clinical, commercial, regulatory)
• Provide thought leadership and strategic direction for the medical affairs team while collaborating with the clinical and commercial teams within Cristcot
• Establishing and maintaining strategic partnerships with KOLs, medical societies and healthcare institutions to position Cristcot as a leader in IBD 
• Lead participation in congresses and seminars, delivering scientific presentations to enhance HCP awareness 
• Oversee medical training and compliance programs to ensure organizational readiness for the commercial launch
• Oversight and analysis of HEOR activities to support product value propositions while keeping current in competitive intelligence and scientific trends
• Examination and continual improvement in the Company’s Quality Management System including Standard Operating Procedures for the medical affairs department
• Ensure compliance with FDA regulations and guidance, the PhRMA Code, OIG guidance, the Sunshine Act/Open Payments, GPP 2022, ACCME standards, and Cristcot’s policies across all medical affairs activities
• Develop and execute the Medical Affairs launch plan and readiness milestones tied to the regulatory timeline, with clear go/no-go criteria
• Hire, train, certify, and deploy the field medical team ahead of approval, with a compliant pre-approval scope of activity
• Lead disease-state and scientific education for the medical community, including the appropriate administration technique and clinical rationale for the drug-device presentation
• Deliver the scientific evidence package that supports formulary review, coverage, and guideline consideration
• Select and manage the medical agency and vendor ecosystem — medical communications, medical information, HEOR/RWE, publications, congress, and field medical technology — including scoping, contracting, and performance management
• Own the Medical Affairs operating budget and phased hiring plan, and manage to plan
• Serve as the senior medical signatory in the promotional and medical-legal review process, and stand up the medical governance forums that support it
• Partner with Safety/Pharmacovigilance on signal detection inputs, medical information-sourced adverse event reporting, and risk communication
• Maintain the separation between medical and commercial activities, including firewalls around field medical engagement, evidence generation, and payer scientific exchange, and escalate scientific integrity concerns independently of the commercial reporting line

Skills and Qualifications:

• Advanced degree in a clinical or scientific discipline (MD, DO, PharmD, or PhD) with 12+ years of progressive medical affairs experience in biopharma, ideally in startup and established companies
• Proven strategic leadership, including 5+ years leading a Medical Affairs function or major sub-function with direct people and budget accountability, and a record of building and scaling medical affairs teams in dynamic, growth-oriented settings 
• At least one U.S. product launch in a Medical Affairs leadership capacity, from pre-approval readiness through commercialization
• Demonstrated experience building an MSL team: territory design, hiring, training, certification, field metrics, and CRM/insights infrastructure
• Working command of the full Medical Affairs remit described above, including medical information operations, publication planning under GPP, and evidence generation spanning RWE and HEOR
• Experience in a small or emerging biopharma environment, with the willingness to operate as a player-coach and produce individual deliverables personally
• Preferred: direct experience in inflammatory bowel disease, gastroenterology, or immunology, and familiarity with the ulcerative colitis treatment landscape and the distal/left-sided disease population
• Preferred: experience with drug-device combination products, including administration training and device-related medical education
• 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
• Entrepreneurial mindset, driving innovation, strategic vision, and business acumen to shape organizational impact
• Exceptional leadership and mentoring skills, inspiring remote teams and fostering a collaborative, innovative culture
• Deep working knowledge of the U.S. healthcare system, payer decision-making, and HEOR activities
• Thorough knowledge of regulatory and compliance standards with a commitment to scientific integrity 
• Passion for continuous learning and improvement
• High integrity, holding oneself to the highest standards of accountability and scientific excellence
• Excellent communication skills, both written and oral, to engage diverse stakeholders
• Commitment to Cristcot’s core values: Integrity, Enterprising Spirit, Generativity and Meritocracy
• Willingness to travel approximately 30-40% domestically, concentrated around congresses, advisory boards, field ride-alongs, KOL engagement, and internal launch meetings; travel is expected to be heaviest in the twelve months surrounding launch

About Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.