Executive Medical Director, Clinical Development

About Us 

Job Overview

Kardigan is seeking a Clinical Development Medical Director to serve as a senior physician-scientist and sponsor Medical Monitor for our programs. Reporting to the Vice President, Clinical Development Lead (CDL), this is a senior individual contributor role. Its value to Kardigan lies in scientific depth, clinical judgment, and medical credibility with investigators, ethics committees, independent data monitoring committees, and health authorities — not in people management or program administration.

The Medical Director is the scientific counterpart to the CDL’s strategic and program accountability. Where the CDL owns the Clinical Development Plan, the program strategy, and program-level accountability for execution, budget, and timelines, the Medical Director owns the scientific and clinical content of the protocol, the medical monitoring of the program’s clinical trials, and the medical integrity of the clinical data and documents that flow from them. Put simply: the CDL decides where the program goes and is accountable for getting it there; the Medical Director ensures that what is designed, run, and reported is medically sound and protects trial participants.

This is a hands-on role. The Medical Director works day to day with the program Clinical Scientist, with Clinical Operations and the contract research organization (CRO) study team, with Drug Safety & Pharmacovigilance, and directly with site investigators — and is expected to stay close to the data throughout the life of each trial.

Essential Duties and Responsibilities

Trial Design and Protocol Development

• Own the scientific and clinical content of the clinical protocol(s) for the [Asset] program: endpoint selection and definitions, inclusion and exclusion criteria, dose selection rationale, safety monitoring provisions, stopping and dose-modification rules, and the schedule of assessments. The CDL owns the protocol as a program deliverable and leads protocol design; the Clinical Scientist leads drafting and amendment activities.
• Apply quality-by-design principles consistent with ICH E6(R3): identify the factors critical to participant protection and data reliability, define pre-specified safety triggers and escalation pathways, and balance scientific rigor against participant burden and recruitment feasibility.
• Author the Medical Monitoring Plan and the clinical data review plan for each trial, and provide medical input to the Safety Management Plan, the risk-based monitoring plan, and the Independent Data Monitoring Committee (IDMC) charter.
• Provide medical and scientific input to the CDL on indication selection, the Target Product Profile (TPP), and the Clinical Development Plan, including review of nonclinical, translational, and PK/PD data that inform dose and design decisions.
• Maintain deep, current knowledge of the therapeutic area and translate investigator and key opinion leader (KOL) insight into protocol design options and decisions.

Medical Monitoring and Clinical Data Review

• Serve as the sponsor Medical Monitor for the program’s clinical trials — the accountable physician for cross-site medical oversight — with availability for urgent site safety queries as defined in the Safety Management Plan. Direct and hold accountable the CRO medical monitor within Kardigan’s sponsor oversight model.
• Own ongoing medical review of emerging clinical data across each trial — safety, laboratory, vital sign, ECG and imaging, and efficacy listings and trends — in partnership with the Clinical Scientist, who leads data review activities and flags signals for Medical Director assessment.
• Rule on eligibility questions, protocol-interpretation queries, and medical escalations from sites; provide the medical assessment of protocol deviations; and document medical rationale so that decision trails are clear and inspection-ready.
• Lead the clincial review of serious adverse events (SAEs), including sponsor causality and expectedness assessment against the Investigator’s Brochure reference safety information and review of SAE narratives and coding, in partnership with Drug Safety & Pharmacovigilance, which owns case processing and expedited regulatory reporting.
• Participate in emergency unblinding decisions and, where the trial design requires it, serve as or designate the unblinded medical reviewer for suspected unexpected serious adverse reaction (SUSAR) reporting while preserving the blind for the program team.
• Lead the clinical content of the internal Safety Review Team: review aggregate safety data at a defined cadence, monitor adverse events of special interest, and recommend actions to the CDL — enhanced monitoring, dose adjustment, enrollment pause, or protocol amendment. The CDL leads program-level benefit–risk decisions and go/no-go recommendations.

Safety Governance, IDMC and Ethics Committees

• Prepare and present clinical and scientific materials to the IDMC (open session), and lead the clinical assessment and implementation of IDMC recommendations in partnership with the CDL and Biometrics.
• Respond to Institutional Review Board (IRB) and Ethics Committee questions on clinical and scientific matters, in partnership with Clinical Operations and Regulatory Affairs.
• Contribute clinical assessments to signal evaluation and benefit–risk documentation, and clinical input to the program safety and risk management plans, which the CDL leads jointly with Drug Safety & Pharmacovigilance.

Sites, Investigators and CRO Partnership

• Act as the primary clinical point of contact for site teams and Principal Investigators throughout the trial, handling clinical queries and clinical escalations.
• Provide clinical and scientific input to site feasibility and selection, and participate in site evaluation and initiation visits as appropriate.
• Lead the scientific content of investigator meetings, and deliver protocol, disease-area, and safety training to investigators, CRO and site-monitoring (CRA) teams, and internal study teams.
• Support recruitment and retention through timely clinical guidance on eligibility and protocol conduct, working with the Clinical Study Lead and the CRO study team.

Clinical Documents and Regulatory Support

• Accountable for the clinical and scientific content of the Clinical Study Report (CSR, including the benefit–risk narrative and patient narratives), the Investigator’s Brochure (IB, including reference safety information), the Development Safety Update Report (DSUR), and Investigational New Drug (IND) annual reports, working with Medical Writing, Biometrics, Regulatory Affairs, and Drug Safety & Pharmacovigilance.
• Provide clinical content for regulatory submissions and briefing documents, and author responses to health authority questions on medical and scientific matters, in partnership with the CDL — who is the primary clinical point of contact for regulatory interactions — and Regulatory Affairs. Attend health authority meetings as the program’s clinical expert when requested.
• Work with Biostats to develop and review the Statistical Analysis Plan for clinical relevance — endpoint definitions, subgroup and sensitivity analyses, and safety analyses — and lead the clinical interpretation of trial results with Biometrics and the CDL.
• Ensure clinical decision-making is documented to support audit and inspection readiness.

Scientific Communication

• Author and review abstracts, manuscripts, congress presentations, and other scientific disclosures of the program’s trial data, and provide clinical and scientific input to the program’s evidence generation plan, in support of Medical Affairs and the CDL, ensuring accuracy, consistency of clinical messages, and scientific integrity.
• Present at investigator meetings, advisory boards, academic steering committees, and scientific meetings as agreed with the CDL, ensuring all external scientific exchange is accurate, balanced, and compliant.

Working with the Clinical Scientist

• Provide day-to-day scientific direction and oversight to the program Clinical Scientist on protocol support, data review, and amendment activities. The Clinical Scientist reports to the CDL; the Medical Director has no formal line-management responsibility but is accountable for the scientific quality of the Clinical Scientist’s output.

Compliance

• Ensure all medical monitoring and clinical development activities are conducted in accordance with Good Clinical Practice (GCP), applicable regulations, and Kardigan policies and SOPs, upholding the highest standards of participant safety, ethics, and scientific integrity.

Role Boundaries with the Clinical Development Lead

The CDL and Medical Director roles are designed as complementary counterparts. The table below summarizes where accountability sits so that the two roles do not overlap.

Area

VP, Clinical Development Lead

Medical Director, Clinical Development

Strategy

Owns the Clinical Development Plan, program clinical strategy, indication selection and TPP

Provides clinicall and scientific input; reviews nonclinical and translational data

Protocol

Owns the protocol as a program deliverable; leads design; accountable for delivery

Owns scientific and clinical content: endpoints, eligibility, dose rationale, safety provisions etc

Execution

Accountable for program-level execution, budget and timelines with the Clin Ops Program Lead

Clinical input to site selection, investigator meetings and training; clinical contact for sites

Medical monitoring

Provides medical oversight of medical monitoring activities

Is the sponsor Medical Monitor: eligibility rulings, SAE causality, data review, unblinding decisions

Safety

Leads program-level benefit–risk and go/no-go with Drug Safety & Pharmacovigilance

Leads Safety Review Team medical content, IDMC materials, and case- and trend-level medical review

Regulatory

Primary clinical point of contact for health authorities

Authors clinical content and responses on medical and scientific matters; attends as medical expert

Documents

Accountable for clinical content of the program overall

Accountable for clinical content of the CSR, IB, DSUR and IND annual reports

External

Owns KOL, investigator and academic relationships for the program

Provides scientific content; may present data and information as agreed with the CDL

People

Line manages the Medical Director Clin Dev and Clinical Scientist

No direct reports; gives day-to-day scientific direction to the Clinical Scientist

Governance

Core member of the Global Program Team (GPT); co-leads the Global Clinical Team (GCT)

Member of the GCT and study teams; attends the GPT when medical topics require

Qualifications and Preferred Skills

Experience

• MD (or equivalent medical degree) required; board certification and meaningful clinical practice experience strongly preferred. Cardiology or cardiometabolic specialization is preferred but not required — the ability to rapidly build deep disease-area expertise is what matters.
• 7+ years of clinical development experience within biotechnology and/or pharmaceutical companies, including substantial hands-on experience in emerging-company settings where physicians operate close to the data and the sites.
• Hands-on experience as a sponsor (or CRO) medical monitor on Phase 2 and Phase 3 trials, including eligibility rulings, SAE causality and expectedness assessment, unblinding decisions, and leadership of internal safety review meetings.
• Demonstrated authorship of the scientific and clinical content of protocols and amendments, Clinical Study Reports, Investigator’s Brochures, and DSURs — not solely review of documents written by others.
• Experience preparing and presenting materials to Independent Data Monitoring Committees and 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 and directing CRO medical monitors.
• Track record of effective, credible partnership with investigators and site teams.

Core Competencies

• Scientific and clinical judgment. Deep therapeutic-area and drug development knowledge applied to endpoint selection, eligibility, dose rationale, and the interpretation of emerging clinical data; recognizes what is clinically meaningful and what is noise.
• Medical monitoring rigor. Disciplined, timely, and well-documented medical decision-making on eligibility, causality, protocol deviations, and safety escalations, with a clear command of GCP, pharmacovigilance requirements, and blinding governance.
• Data literacy and statistical fluency. Comfortable working directly with listings, trend outputs, and data visualizations; understands estimands, interim analyses, multiplicity, and sources of bias well enough to evaluate data critically and to partner effectively with Biometrics.
• Regulatory and scientific writing. Produces clear, accurate, and defensible medical content for protocols, CSRs, IBs, DSURs, and health authority responses, and aligns narratives with source data.
• Clinical credibility and communication. Engages investigators, IDMC members, ethics committees, and health authorities with confidence and balance; explains medical reasoning clearly to non-physician colleagues.
• Collaborative execution. Works effectively as a senior individual contributor within a program team — influencing through expertise rather than authority, partnering closely with the CDL, Clinical Scientist, Clinical Operations, Biometrics, and Drug Safety & Pharmacovigilance, and escalating early.

Other

• Strong patient-centric orientation and an unwavering commitment to participant safety as the foremost consideration in every medical decision.
• Ability to work on-site four days per week in Princeton, New Jersey; flexibility to travel to investigator meetings, clinical sites, scientific congresses, and health authority interactions as needed.