--- title: 'Medical Director, Clinical Development at Kardigan' canonical: 'https://feeny.ai/job/medical-director-clinical-development-kardigan-princeton-h0r5qrx667b5' type: 'job' last_seen: '2026-10-17' --- # Medical Director, Clinical Development at Kardigan - **Company:** Kardigan - **Location:** Princeton, NJ - **Posted:** 2026-10-13 - **Last confirmed live:** 2026-10-17 - **Apply:** https://job-boards.greenhouse.io/kardigan/jobs/5451339008 ## Job description ## About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients. At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries. These values are the foundation of our work, empowering us to make a real difference, every day. 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. ## About Kardigan ## Company Overview - **One-liner**: Kardigan is a publicly traded biopharmaceutical company developing targeted cardiovascular therapies with the aim of transforming treatment from symptom management toward functional cures. - **Entity Type**: Public (ticker not available from provided sources; IPO closed as per company announcement) - **Headquarters**: South San Francisco, California, United States (with additional offices in Princeton, New Jersey and Chicago, Illinois) - **Founded**: Year not specified in available sources - **Founders**: Tassos Gianakakos (Co-Founder, CEO & Chair), Dr. Jay Edelberg (Co-Founder & Chief Medical Officer), Dr. Bob McDowell (Co-Founder & Scientific Adviser), Brianne Puglisi (Co-Founder) ## Core Business - **Primary industry**: Biopharmaceuticals – cardiovascular drug discovery and development - **Target customers**: B2B / B2G – healthcare providers, hospitals, payers, and patients; the company develops prescription medicines for serious cardiovascular conditions - **Mission or purpose statement**: “To make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.” ([kardigan.bio](https://www.kardigan.bio/)) ## Products & Services - **Tonlamarsen**: A Phase 2/3 candidate for acute severe hypertension (ASH) and uncontrolled hypertension. Positive Phase 2 data presented as a late-breaker at ACC.26 and simultaneously published in JACC. ([kardigan.bio](https://www.kardigan.bio/)) - **Danicamtiv**: A Phase 3 candidate for genetic dilated cardiomyopathy (DCM), targeting the underlying inherited cardiac muscle disease. ([kardigan.bio](https://www.kardigan.bio/)) - **Calcific Aortic Valve Stenosis (CAVS) Program**: A late-stage clinical program addressing calcium deposition that stiffens the aortic valve. ([kardigan.bio](https://www.kardigan.bio/)) - **Prolaio Subsidiary**: An AI and real‑world data platform integrated into Kardigan to generate insights, inform clinical trial design, and reduce time/cost of drug development. ([kardigan.bio](https://www.kardigan.bio/about-us/)) - **Cardiac Intelligence Platform**: A discovery and translational research engine that uses real‑world patient data, AI, and deep cardiovascular expertise to identify disease drivers and design targeted therapies. ([kardigan.bio](https://www.kardigan.bio/)) ## Market Standing - **Valuation/Market Cap**: Not disclosed in provided sources - **Key Metric**: Public company (IPO closed); annual revenue not disclosed - **Notable Investors/Partners**: Not explicitly listed in provided sources; company built on the team’s track record from MyoKardia (acquired by Bristol Myers Squibb for $13.1B in 2020) - **Growth Signals**: - Positive Phase 2 pivotal data for Tonlamarsen in hypertension, presented at ACC.26 and published in JACC - Three late‑stage clinical programs (CAVS, ASH, DCM) running in parallel - Active job postings across 210+ roles in clinical operations, data science, manufacturing, and corporate strategy, indicating scaling ([job-boards.greenhouse.io/kardigan](http://job-boards.greenhouse.io/kardigan)) - Integration of Prolaio’s AI platform to accelerate R&D ## Competitive Advantages - **Leadership expertise**: CEO Tassos Gianakakos previously scaled MyoKardia from startup to a $13.1B acquisition; the team includes veterans from MyoKardia, Sanofi, BMS, and Merck. - **Parallel pipeline strategy**: Multiple late‑stage programs targeting distinct cardiovascular diseases (valve, hypertension, cardiomyopathy) de‑risks development and creates data synergies. - **Cardiac Intelligence platform**: Proprietary combination of real‑world data, AI, and deep biological insight to move beyond symptom management toward modifying underlying disease. - **Focus on functional cures**: Each program aims to alter the course of disease rather than merely treat symptoms, creating potential for breakthrough efficacy. ## Strategic Focus - **Advance late‑stage clinical trials**: Continue Phase 2/3 studies for Tonlamarsen, Danicamtiv, and CAVS while preparing for potential regulatory submissions. - **Expand platform capabilities**: Leverage Prolaio’s AI and real‑world evidence to design smarter, faster trials and discover new drug targets. - **Build commercial infrastructure**: Growing corporate strategy, medical affairs, and manufacturing teams in South San Francisco, Princeton, and Chicago signals preparation for launch. ## Why Work Here - **Culture**: “Everything we do starts with patients – and it’s powered by people.” Emphasis on collaboration, purpose‑driven work, and achieving the impossible together. Mission‑oriented environment focused on curing cardiovascular disease. ([kardigan.bio](https://www.kardigan.bio/job-openings/)) - **Work model**: Roles are listed for South San Francisco, Princeton, NJ, and Chicago, IL; likely on‑site/hybrid given the lab and clinical development nature. Not purely remote. - **Benefits**: - Competitive salaries and annual bonus program - Comprehensive medical, dental, and vision coverage - 401(k) plan, life and disability insurance - Flexible spending and health savings accounts - Commuter benefits, cellphone allowance - Paid holidays and time off - Employee assistance program ([kardigan.bio](https://www.kardigan.bio/job-openings/)) - **Engineering & data science culture**: Active recruitment for data analytics, AI, and clinical data science roles; Executive Director of Data, AI & Collaboration Services is an open position, reflecting a strong tech‑driven R&D approach. ## Sources 1. [kardigan.bio](https://www.kardigan.bio/) – Company homepage and pipeline descriptions 2. [kardigan.bio/about-us](https://www.kardigan.bio/about-us/) – About Us, mission, and Prolaio integration 3. [kardigan.bio/job-openings](https://www.kardigan.bio/job-openings/) – Careers page with benefits and open roles 4. [kardigan.bio/leadership](https://www.kardigan.bio/leadership/) – Leadership team and co‑founder backgrounds 5. [job-boards.greenhouse.io/kardigan](http://job-boards.greenhouse.io/kardigan) – Detailed job listings (32+ postings) ## Other roles at Kardigan - [Contracts Manager (Prolaio)](https://feeny.ai/job/contracts-manager-prolaio-kardigan-chicago-42r8rkrddx72) — Chicago, IL - [Executive Director, Global Program Manager](https://feeny.ai/job/executive-director-global-program-manager-kardigan-princeton-22n8a9rqn2kb) — Princeton, NJ - [Director, Clinical Quality Lead](https://feeny.ai/job/director-clinical-quality-lead-kardigan-south-san-francisco-california-united-qzg2emd2he5j) — South San Francisco California United States Princeton New Jersey, United States - [Senior Director, Biostatistics](https://feeny.ai/job/senior-director-biostatistics-kardigan-princeton-vb12pjj1sw78) — Princeton, NJ - [Senior Director, Clinical Operations Program Lead](https://feeny.ai/job/senior-director-clinical-operations-program-lead-kardigan-princeton-wswqw80bw3hb) — Princeton, NJ - [Senior Contracts Manager, Clinical Agreements](https://feeny.ai/job/senior-contracts-manager-clinical-agreements-kardigan-princeton-xthmawfmq41y) — Princeton, NJ - [Senior Director, Head of Statistical Programming](https://feeny.ai/job/senior-director-head-of-statistical-programming-kardigan-princeton-7ct1vkgyav05) — Princeton, NJ - [Manager, Forecasting](https://feeny.ai/job/manager-forecasting-kardigan-evanston-qvn5b2dgyy11) — Evanston, IL - [Manager, Accounting](https://feeny.ai/job/manager-accounting-kardigan-princeton-7tcvpdfvzv82) — Princeton, NJ - [Executive Director, Regulatory Strategy](https://feeny.ai/job/executive-director-regulatory-strategy-kardigan-princeton-b56gzz2zdy4z) — Princeton, NJ