Senior Medical Director/Medical Director, Clinical Trial Lead
KardiganSouth San Francisco, California, United States · Posted 28 days agoDescription
About Us
Position Title: Senior Director / Medical Director – Clinical Trial Lead
Department: Clinical Development
Reports To: Vice President, Clinical Development Lead
Location: South San Francisco, CA or Princeton, NJ – On-site 3-4 days per week
Job Overview
The Senior Director / Medical Director - Clinical Trial Lead will be a physician with extensive drug development expertise who will be expected to lead to the clinical development strategy for the phase 1-3 clinical trials of the program, including the protocol design, operational planning and trial execution, medical and safety monitoring, trial close out, trial results interpretation, and preparation for dissemination of the trial results, working with academic partners.
Essential Duties and Responsibilities
- Leads the aforementioned clinical activities for the phase 1-3 trials for the program as a key member of the Clinical Strategy Team, that is embedded within the Global Project Team, including taking primary responsibility for medical monitoring, data monitoring, and safety monitoring for the clinical development function
- Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan, working closely with Medical Affairs colleagues
- Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
- Takes primary responsibility for the clinical development function, working with statisticians, modelers, and project team-members, for contributing to the creation of trial-specific statistical analysis plans, and for the interpretation, reporting, and dissemination of the final results, working closely with academic partners
- Contributes to and provides oversight of the operational aspects of study conduct including site selection and activation, site investigator and staff training, site start up and activation, screening and recruitment of trial participants, and trial close-out activities
- Leads the authoring and review of clinical parts of regulatory submissions, regulatory briefing documents, Investigational Brochures, scientific disclosures of trial results, and other relevant documents.
- Leads clinical responses to regulatory or IRB/Research Ethics Committee for information requests.
- Works with Key Opinion Leaders to incorporate their input into trial protocol designs, clinical development plans, clinical trial site selection, and regulatory interactions
- Ensures consistency of clinical content and scientific messages across abstracts, publications, and other external documents
- Contributes to the TPP (target product profile) and Global Product Safety (GPS) plans
- Give scientific presentations at advisory boards, trial academic committees, key scientific meetings, and other venues
Qualifications and Preferred Skills
- MD, or equivalent medical degress is required, and cardiology specialty training and cardiology board certification strongly preferred
- Minimum 10 years’ clinical development experience working cross-functionally in the regulated medical products industry is required.
- Experience designing and running Phase 1-3 trials, experience with preparation of and submissions of INDs and NDAs also preferred
- Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
- Strategic Agility: Ability to develop and execute complex strategies.
- Collaboration/Relationship Management: Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment.
- Influencing: Demonstrated ability to lead a matrixed team through influence. Proven track record of influence strategy, initiative(s) implementation, and decision-making. Proactively influences and motivates others to achieve objectives.
- Decision Making: Strong decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact.
- Communication: Excellent communication skills (both orally and written) is critical to the success of the role.
- Business Excellence: Good at developing the processes necessary to get things done, knowing how to organize people and activities, and knowing what to measure and how to measure. Demonstrated ability to interpret data into actionable items
- Negotiation: Proven negotiation skills that effectively drive discussions and decisions to desired end results that have broad organizational impact.
Similar jobs
Est. 250,000 USD
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 treatme…
Est. 165,000 USD
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 treatme…
Est. 140,000 USD
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 treatme…
Est. 120,000 USD
Cordance is dedicated to accelerating the growth of vertically focused business-to-business (B2B) software-as-a-service (SaaS) companies through acquisition and long-term tactical and financial guidance. We’re experience…
Est. 85,000 USD
Job Overview: The Business Development Territory Manager at Kolmac Integrated Behavioral Health and all its subsidiaries ("Kolmac" or the "Company”) plays a critical role in fostering strong relationships with patients,…
Est. 85,000 USD
Job Overview: The Business Development Territory Manager at Kolmac Integrated Behavioral Health and all its subsidiaries ("Kolmac" or the "Company”) plays a critical role in fostering strong relationships with patients,…
Est. 250,000 USD
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 treatme…
Est. 80,000 USD
Cordance is dedicated to accelerating the growth of vertically focused business-to-business (B2B) software-as-a-service (SaaS) companies through acquisition and long-term tactical and financial guidance. We’re experience…
Est. 140,000 USD
(ID: 2026-3432) Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organiz…
About Agoda At Agoda, we bridge the world through travel. Our story began in 2005, when two lifelong friends and entrepreneurs, driven by their passion for travel, launched Agoda to make it easier for everyone to explore…
Est. 115,000 USD
Solutions Analyst Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert…
Est. 250,000 USD
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 treatme…
Est. 165,000 USD
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 treatme…
Est. 90,000 USD
Cordance is dedicated to accelerating the growth of vertically focused business-to-business (B2B) software-as-a-service (SaaS) companies through acquisition and long-term tactical and financial guidance. We’re experience…
Est. 120,000 USD
Position Overview The Associate Director, Video Partnerships is a high-level client team specialist role requiring strong leadership and managerial skills. The role involves a strong knowledge of the video space and avai…
Est. 80,000 USD
Job Overview: The Business Development Territory Manager at Kolmac Integrated Behavioral Health and all its subsidiaries ("Kolmac" or the "Company”) plays a critical role in fostering strong relationships with patients,…
Est. 85,000 USD
Business Overview We believe in the power of media to reshape our industry and orchestrate a brand’s entire consumer experience, by balancing both what unites people and what makes them different. When brands unite peopl…
Est. 152,500 USD
About SRS Acquiom SRS Acquiom delivers the smartest way to run a deal™ through a platform and services designed to help deal parties manage complex M&A and loan agency transactions more efficiently. Based in Denver,…
Est. 200,000 USD
Cordance is dedicated to accelerating the growth of vertically focused business-to-business (B2B) software-as-a-service (SaaS) companies through acquisition and long-term tactical and financial guidance. We’re experience…
Est. 85,000 GBP
At NiCE, we don’t limit our challenges. We challenge our limits. Always. We’re ambitious. We’re game changers. And we play to win. We set the highest standards and execute beyond them. And if you’re like us, we can offer…
Est. 140,000 USD
Senior Product Manager - Data Onboarding Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every cl…
Est. 80,000 GBP
CX Transformation Specialist - Product & Experience Location: London (Hybrid) | Practice Area: Product & Experience | Type: Permanent Help leading financial institutions reimagine customer experiences through str…
Est. 165,000 USD
(ID: 2026-1572) Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organiz…
Est. 115,000 USD
Join Axon and be a Force for Good. At Axon, we’re on a mission to Protect Life. We’re explorers, pursuing society’s most critical safety and justice issues with our ecosystem of devices and cloud software. Like our produ…
Company Introduction We exist to wow our customers. We know we’re doing the right thing when we hear our customers say, “How did I ever live without Coupang?” Born out of an obsession to make shopping, eating, and living…
Est. 110,000 USD
As a family-owned and operated company, we feel a special obligation to the employees who comprise our Taco family. We are committed to offering employees access to the tools necessary to live long and productive lives.…
At NiCE, we don’t limit our challenges. We challenge our limits. Always. We’re ambitious. We’re game changers. And we play to win. We set the highest standards and execute beyond them. And if you’re like us, we can offer…
Est. 80,000 GBP
Who We Are VML is a leading creative company that combines brand experience, customer experience, and commerce, creating connected brands to drive growth. VML is celebrated for its innovative and award-winning human-firs…
At NiCE, we don’t limit our challenges. We challenge our limits. Always. We’re ambitious. We’re game changers. And we play to win. We set the highest standards and execute beyond them. And if you’re like us, we can offer…
Truveta provides unprecedented real-world data and real-time intelligence, powered by a dataset built with and owned by US health systems united in a mission of Saving Lives with Data. Together, we power breakthrough med…