Associate Medical Director *PC 1609

Your Role: 

At the Associate Medical Director position, you will serve as a key member of the Clinical Development Team, provide input into clinical trials design and execution. You may serve as a clinical trial physician or medic assigned to specific clinical tasks on clinical trials. You should be able to work effectively in a matrix, with multiple departments across the organization, and with external stakeholders such as Investigators, CROs, Various Vendors Patient's Advocacy Groups and Regulatory Agencies.

Essential Duties and Responsibilities: 

• As an Associate Medical Director in Clinical Development organization, you will work collaboratively with other functions, such as Clinical Operations, Regulatory Affairs, Data Management, Biostatistics and Pharmacovigilance.
• You will provide medical support and conduct medical monitoring activities on assigned clinical trials, participate in meetings, reviews, discussions and other interactions relevant to the conduct of clinical trials.
• Input into data review and analysis on company sponsored clinical trials.
• Support medical team in the development of comprehensive scientific strategy and clinical development plan for assigned pharmaceutical products.
• Collaborate with other internal functions such as Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, and Pharmacovigilance as well as external collaborators to develop consistent language and criteria for the clinical trial documentation such as Study protocol, Informed Consent Form (ICF), Case Report Forms (CRFs), Investigator’s Brochure (IB) etc. as needed.
• Contribute to the development of clinical trial protocols, clinical study reports and other clinical documents · Collaborate with Data Management, and Clinical Scientists and other functions on comprehensive clinical trials data review · Contribute to medical data review and provide input into safety reports Provide clinical input into regulatory documents.
• Travel Requirements 10-20% of work/time.

Requirements:

• Medical Doctor, ideally licensed in the U.S.; +8 years pharmaceutical industry experience, including relevant experience and training in in clinical development/medical affairs/pharmacovigilance.
• Experience reviewing clinical data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data; oncology experience is preferred.
• Thorough understanding of the drug development process and context applicable to clinical development activities.
• Independently motivated, detail oriented and good problem-solving ability.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent communications skills.

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

The hiring range for this position is expected to fall between $157,528 - $185,288/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. 

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reas