This is what you will do

Lead a cross functional team in the design and execution of a clinical study and provide input into the global clinical development plans and strategy for a therapeutic area.

You will be responsible for

Lead preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.

Mentor and develop Clinical Development Scientists in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents

Participate in Investigator meeting planning and execution and/or onsite initiation meetings

Study execution including country and site selection, site training and startup and data monitoring; expertise in data analysis and presentation. Depending upon specific expertise in translational science, may lead a translational sub team of the clinical team.

Engage with clinical investigators nonclinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy.

Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.

Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting.

Maintain awareness of internal and external developments (scientific, clinical, industry, and regulatory) that could impact the development plan, including attendance at major conferences, participation in competitive intelligence activities, and periodic literature review

Evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy

You will need to have

• PhD, PharmD or equivalent degree OR equivalent years of experience

• History of industry or academic clinical or basic science research

• Excellent written / oral communication skills

• Ability to think strategically

• Attention to detail

The annual base pay for this position ranges from 203,709.60 - 305,564.40 USD Annual . Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date