Senior Director/Medical Director, Clinical Trial Lead

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.  

• Alignment: Proven track record of achieving alignment with internal and external stakeholders  

Exact Compensation may vary based on skills, experience and location.