Chief Medical Officer


Job ID 18-00023

Industry Pharma

Job Type Permanent

Location East Windsor, NJ

Description

ESSENTIAL DUTIES & RESPONSIBILITIES
% OF TIME FREQUENCY ESSENTIAL DUTIES

30 - Daily
• Direct and oversee the design and implementation of all stage clinical projects.• Ensure that the overall scientific and medical content of all clinical programs is sound. • Prepare clinical development plans and institute properly approved clinical protocols. • Design scientifically rigorous and maximally cost-effective clinical development programs for the desired indication(s). Present and defend protocols. • Ensure that Serious Adverse Events are properly reported on a global basis.
20 - Daily
• Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, NDAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex safety or efficacy issues.
20 - Daily
• Review potential in-licensing candidates. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities. • Contribute and support clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
20 -Daily
• As the organization grows the role will manage multidisciplinary professionals and clinical scientists to support career and project advancement. • The role will ensure communication with managed care, pharmacy benefit managers and other key stake holders on the scientific value of the products.

OTHER RESPONSIBILITIES
The CMO will be responsible for continued success in our strategic therapeutic areas through innovative research and outstanding scientific leadership. The CMO will based in home office and will have full responsibility for the clinical strategy, implementation of the clinical development and operations plan, as well as oversight of the daily operation of drug development projects whether internal or external. She/he will collaborate with key internal stakeholders such as, business development, scientific staff across multifunctional groups and external stakeholders including CROs, key opinion leaders and other key healthcare stakeholders. At an appropriate time the role will be responsible for building the medical infrastructure internally which includes medical sales liaison teams and scientific communications team. This will also include setting up complaint processes and SOPs for the medical team to able to operate in a compliant manner. The role will also manage selection of appropriate CROs which can complete clinical trials in a timely manner and within budget. The CMO will be responsible for designing and managing the budgets for the department to achieve the goals and visions of the company.The Chief Medical Officer will join the company's senior leadership group. The position will work in close co-ordination with VP of Business Development to communicate internally and drive internal and external cross-functional teams through all stages till filing of the NDAs.



Qualifications

QUALIFICATIONS PREFERRED & REQUIRED
Required :• PharmD or MD with a valid medical license. Medical specialty and sub-specialty training and certification.• Prior experience in clinical research design/implementation of protocols, review/interpretation of data is required. This could be obtained through prior work in the pharmaceutical industry, Regulatory, or academic clinical research.• Ten or more years of industry related experience is desirable. Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience. Knowledge of clinical trial management, data management, and drug development process. • A detailed understanding of human disease, pharmacology, biochemical medicine and the relevance of pharmacodynamic/clinical endpoints that underlie the action of the drug(s) being developed. • Excellent oral and written communication skills, as well as interpersonal skills.• Hard working, driven to achieve creative and sound results.• Worked in small and big pharma• Thorough understanding of basic science technologies as applied to medical targets• Broad-based scientific knowledge across human health therapeutic areas.• Well versed with the compliance issues and manage the organization in a compliant manner.• Strong analytical skills and strategic thinking.• Strong networking, interpersonal skills and organizational meticulousness.• Strong written and oral communication skills.• Ability to influence decisions or issues that have broad business impact.• Travel required 40% of the time.• Expertise in word, powerpoint, exel and data sources to aid analysis.• Ability to think innovatively and think out of the box• Ability and willingness to roll up the sleeves and get work done• Existing relationships with vendors and external partners as needed to supplement internal capabilities.

LICENSES, CERTIFICATIONS, MEMBERSHIPS, ETC.
MD or PhD or PharmD