Senior Director, Clinical Lead

Position Title:  Senior Director, Clinical Lead 

Department:  Program Management 

Reports To:  Vice President, Global Program Head

Location: Princeton, NJ or South San Francisco, CA – On-site 4 days per week (Mon to Thurs) 

Job Overview 

The Senior Director, Clinical Lead will be expected to lead to the clinical strategy, planning and execution for key aspects of clinical development of the program. Direct responsibilities include working with Global project team to identify the best clinical study that will provide the target product profile that was developed, planning and executing all activities related to the clinical trials of the program and that may also include other activities such as publication of study results and presentations. 

Essential Duties and Responsibilities 

• Leads Clinical activities and is a key member of the Global Project Team. 

• In charge of strategy and planning clinical development of phase 1 to phase 3 and post launch study protocols, amendments, and other clinical research related documents and study reports 

• Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan 

• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program 

• Interpret and communicate clinical trial data 

• Takes primary responsibility, working with statisticians, modelers, and project team-members, for study data analysis and interpretation, reporting and communication 

• Assists and provides oversight with the operational aspects of study conduct including site selection and activation, site investigator and staff training, budget planning and contract review 

• Leads the clinical part of the submission dossier in regulatory filings dossiers, and updates, regulatory briefing documents, Investigational Brochures, and other relevant documentation 

• Leads the clinical strategic planning, authoring and review of clinical parts of regulatory submissions and scientific data disclosures of the studies. 

• Leads clinical medical responses to regulatory or IRB/Research Ethics Committee information requests. 

• Works with external and internal Key Opinion Leaders to help identify and validate new drug targets and related biomarkers 

• Ensures consistency of clinical content and scientific messages across publications and materials 

• Contribute to TPP (target product profile) and Global Product Safety (GPS) development 

• Will make scientific presentation at advisory boards, key scientific meetings and external committee meetings 

Qualifications and Preferred Skills 

• MD., or another health sciences area (e.g.: PharmD) is required. 

• Minimum 5 years’ clinical development experience working in the regulated medical products industry is required. 

• Experience designing and running Phase 1-3 trials, and submission of NDA would be a plus 

• IND preparation and filing is a plus 

• Experience in cardiovascular disease is preferred  

• Experience working cross-functionally 

• Management experience (direct reports) desirable, not required 

• 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 of leading 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, knows how to organize people and activities, and knows 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