Medical Director level role that provides strategic oversight for clinical development programs and associated clinical trials.
- Ensures the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the program.
- Enhances and streamlines programs in the Clinical Development organization.
- Develops proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials.
Planning and Execution
- Ensures the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the program.
- Ensures medical consistency of clinical data for submission to the FDA and other regulatory organizations.
- Oversees the safety profile of a portfolio of investigational drugs in accordance with corporate policies and legal regulations.
Financial Outcome
- Ensures consistency of coded terms for adverse events and develops strategies to avoid failures to identify harm.
- Collaborates with Marketing to evaluate product candidates and to determine production indication.
Operation and Improvement
- Enhances and streamlines programs in the Clinical Development organization.
- Identifies potential study risks and implements solutions to avoid delays to the clinical study execution.
- Ensures all clinical development plans, protocols, reports publications and regulatory documents are of the highest quality and scientific, operational and ethical standards, in compliance with external regulations, and completed on time.
Innovation
Develops proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials.
Talent Development and Organization Growth
Facilitates continuous learning and knowledge transfer throughout the duration of the project, as well as upon its completion.
External / Internal Relationship
- Collaborates cross-functionally to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives.
- Represents organization at high level external meetings.
Educational Requirements
Medical Degree (M.D.), possessing medical expertise in the therapeutic area of oncology or non-oncology is required.
Experience
- 5 to 7 years of in-depth knowledge and clinical development experience within the pharmaceutical or biotechnology industry, or 7 to 9 years clinical trial experience in an academic setting, collaborating with pharmaceutical sponsors.
- Experience as a Clinical Development Medical Monitor providing clinical leadership, strategic medical input, and medical evaluation of safety data for all clinical deliverables.
- Experience working with regulatory bodies and creating scientific methodology for unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of study results.
Other Skills / Abilities and Working Conditions
Skills and Abilities
Technical Skills
- Possesses a thorough knowledge and understanding of clinical development in various therapeutic areas, the impact of pharmacologic agents on humans, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans.
- Possesses proficiency with pharmacovigilance programs including signal detection and safety supportive of drug safety and Medical Dictionary for Regulatory Activities (MedDRA).
Cognitive Skills
- Strong analytical skills and problem-solving capabilities.
- Strategic thinker with ability to create and implement short- and long-term plans to meet timelines and outcomes.
Language / Interpersonal Skills
- Excellent communication and presentation skills.
- Ability to effectively present technical information across the organization.
Other
Working Conditions
Physical Demands
Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting / moving up to 15 pounds
Work Environment
The noise level in the work environment is usually quiet.
Business Travel
This role requires the incumbent to travel up to 30% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and / or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)
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