Executive Medical Director, Clinical Development

Kardigan•Princeton, NJ

10h•Hybrid

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop targeted treatments for cardiovascular diseases. Founded by leaders who previously worked at MyoKardia, Kardigan possesses a strong research platform, a pipeline of late-stage candidates, and a driven team focused on patient well-being. The company's values emphasize patient focus, authenticity, continuous learning, teamwork, and enabling the impossible through innovation and risk-taking.

Requirements

MD (or equivalent medical degree) required.
Board certification and meaningful clinical practice experience strongly preferred.
Cardiology or cardiometabolic specialization preferred but not required.
7+ years of clinical development experience within biotechnology and/or pharmaceutical companies.
Substantial hands-on experience in emerging-company settings.
Hands-on experience as a sponsor (or CRO) medical monitor on Phase 2 and Phase 3 trials.
Demonstrated authorship of the scientific and clinical content of protocols and amendments, Clinical Study Reports, Investigator’s Brochures, and DSURs.
Experience preparing and presenting materials to Independent Data Monitoring Committees.
Experience responding to IRB/Ethics Committee and health authority questions.
Experience contributing clinical content to INDs and NDA/BLA submissions preferred.
Experience working within a CRO-outsourced, sponsor-oversight operating model.
Experience directing CRO medical monitors.
Track record of effective, credible partnership with investigators and site teams.
Scientific and clinical judgment.
Deep therapeutic-area and drug development knowledge.
Medical monitoring rigor.
Data literacy and statistical fluency.
Regulatory and scientific writing skills.
Clinical credibility and communication skills.
Collaborative execution skills.
Strong patient-centric orientation.
Unwavering commitment to participant safety.
Ability to work on-site four days per week in Princeton, New Jersey.
Flexibility to travel as needed.

Nice To Haves

Cardiology or cardiometabolic specialization is preferred but not required — the ability to rapidly build deep disease-area expertise is what matters.
Experience contributing clinical content to INDs and NDA/BLA submissions preferred.

Responsibilities

Serve as a senior physician-scientist and sponsor Medical Monitor for Kardigan's programs.
Own the scientific and clinical content of clinical protocols, including endpoint selection, eligibility criteria, dose rationale, safety monitoring, and assessment schedules.
Apply quality-by-design principles to ensure participant protection and data reliability.
Author the Medical Monitoring Plan and clinical data review plan for each trial.
Provide medical and scientific input on indication selection, Target Product Profile (TPP), and Clinical Development Plan.
Maintain deep knowledge of the therapeutic area and translate insights from investigators and Key Opinion Leaders (KOLs) into protocol design.
Serve as the sponsor Medical Monitor for clinical trials, providing cross-site medical oversight and handling urgent site safety queries.
Direct and hold accountable the CRO medical monitor within Kardigan’s sponsor oversight model.
Conduct ongoing medical review of emerging clinical data, including safety, laboratory, efficacy, and trends.
Rule on eligibility questions, protocol-interpretation queries, and medical escalations from sites.
Provide medical assessment of protocol deviations and document medical rationale for inspection readiness.
Lead the clinical review of serious adverse events (SAEs), including causality and expectedness assessment.
Participate in emergency unblinding decisions and serve as or designate the unblinded medical reviewer for SUSAR reporting.
Lead the clinical content of the internal Safety Review Team, monitoring adverse events and recommending actions.
Prepare and present clinical and scientific materials to the Independent Data Monitoring Committee (IDMC).
Respond to Institutional Review Board (IRB) and Ethics Committee questions on clinical and scientific matters.
Contribute clinical assessments to signal evaluation and benefit-risk documentation.
Act as the primary clinical point of contact for site teams and Principal Investigators.
Provide clinical and scientific input to site feasibility and selection, and participate in site evaluation and initiation visits.
Lead the scientific content of investigator meetings and deliver training to investigators, CROs, and internal teams.
Support recruitment and retention through timely clinical guidance.
Accountable for the clinical and scientific content of the Clinical Study Report (CSR), Investigator’s Brochure (IB), Development Safety Update Report (DSUR), and Investigational New Drug (IND) annual reports.
Provide clinical content for regulatory submissions and author responses to health authority questions.
Attend health authority meetings as the program’s clinical expert when requested.
Develop and review the Statistical Analysis Plan for clinical relevance and lead the clinical interpretation of trial results.
Ensure clinical decision-making is documented to support audit and inspection readiness.
Author and review abstracts, manuscripts, and congress presentations of the program’s trial data.
Provide clinical and scientific input to the program’s evidence generation plan.
Present at investigator meetings, advisory boards, and scientific meetings.
Provide day-to-day scientific direction and oversight to the program Clinical Scientist.
Ensure all medical monitoring and clinical development activities are conducted in accordance with GCP, applicable regulations, and company policies.