Job Title: Medical Director (Marketed Products Development)
Location: Remote
Duration:  06 Months
EST preferred, or CST

Summary:
The Medical Director Marketed Products Development (MDMPD) Clinical Science is accountable for Medical Sponsor and Clinical oversight for assigned marketed products globally. Participates in new business evaluation. Usually responsible for multiple products.
 
The MDMPD is an integral member of an Marketed Products Development Team (MPDT) in Global Medical that is responsible for providing dedicated support for the products under its purview. The MDMPD interacts and partners with marketed products MPD affiliated function leads (regulatory affairs, global safety/pharmacovigilance, global development operations and project management) to set Global Medical strategy and prioritize functional area support for assigned MP portfolio. This individual is responsible for medical and clinical scientific leadership for the assigned MPDT and product specific global program teams (GPT) or established product teams (EPT) as required,
 
The MDMPD provides Medical Sponsor Oversight for all assigned products managed by the MPDT as part of the dedicated, integrated functional area support to ensure the ability of to meet its corporate obligations as MAH for assigned products. The MDMPD provides medical and clinical leadership to make sure that the MPDT anticipates potential compliance risks and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
 
The MDMPD will be required to be the medical and clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products in order to provide medical, clinical and scientific support, guidance, mentoring and leadership across these areas.
 
RESPONSIBILITIES AND ACCOUNTABILITIES: 
The Medical Director Marketed Products will be responsible for, and participate in the following activities:
 
Marketed Product Clinical Science support & Leadership

•  Partner with Marketed Product Project Manager to coordinate functional support for assigned products within the MPDT. Provide medical and clinical scientific leadership and expertise for assigned products to support other function leads within the MPDT.  
• Establish integrated partnership(s) with MPD affiliated functional leads in R & D (regulatory affairs, global safety/pharmacovigilance, global development operations). 
• Collaborates with the commercial organization and Established Products Teams and Sub Teams 
• Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Global Commercial, LOC MDs,  Regional Business Units (e.g., product brand leads) and LOC product leads.  
• Forms integrated partnerships with and works with Global Product Team Leaders (GPL) and Established Product Team Lead (EPTL) as necessary, and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across assigned products. Ensure the MPDT in Global Medical works effectively to support GPT/EPTs. 
• Medical Monitoring and supervisions and guidance for vendor medical monitors. 
• Forms integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor medical and clinical deliverables for all products in assigned MPDT.  Ensure highest quality of medical/clinical science input and clinical components of deliverables from the strategic partner vendor. 
• Partners with strategic partner vendor(s) and drives medical and clinical scientific activities relating to the preparation/approval of protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed.  Provides oversight of strategic partner MDs/clinical staff involved in these activities. Accountable for the successful design, execution and interpretation of clinical studies.  
• Oversee the strategic partner vendor(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, protecting the safety of patients within the study. Responsible for internal oversight of strategic partner vendor medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with global safety/Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity. 
• Establish integrated partnership with strategic partner clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH. 
• Participates in cross functional non-project-specific initiatives and committees on behalf of project clinical perspective. 
• Presents study conclusions to management and determine how individual study results impact the product strategy. Interprets data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients. 
• Participate in and support all required regulatory submissions/interactions for assigned products.  Represent as Responsible Medical Doctor and Medical/Clinical expert to regulatory agencies globally for assigned products as needed. Support Local Operating Company (LOC) medical staff for all regulatory agency interactions as needed. Drive medical and clinical scientific input and development of required documents for regulatory applications/submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.  
• Provide scientific education and mentoring for internal and external audiences (academic partners, scientific community, regulatory agencies) 
• Oversee compliance with internal SOPs and external legal requirements, including training of personnel, contractual arrangements with external service providers and partner companies. 

External Interactions

• Build and develop medical and clinical expert relationships to ensure delivery and maintenance of  state-of-the-art medical therapeutic and clinical scientific expertise into medical and clinical  support for assigned marketed products in Global Medical. 
• Participates in meetings with regulatory agencies as required 
• Represent on external bodies as needed. 

Due Diligence, Business Development & Alliance Projects

•  Participate and conduct clinical due diligence evaluations and development of clinical development plans for potential alliances and or in-licensing opportunities. 
• Assess both scientific and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans. 
• Interacting with upper management of potential partner/acquisition companies during due diligence visits and alliance negotiations, and actively participating on internal assessment teams in conjunction with commercial colleagues. 

REQUIRED EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:

• MD or internationally recognized equivalent plus 6 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Experience in rare disease and/or hematology area preferred
• NDA/MAA/Submission experience preferred
• Track record and demonstrated ability to lead and manage both science and business aspects of drug development.Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals 

Skills

• Superior communication, strategic, interpersonal and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities across multinational business cultures 

Knowledge

• Emerging research in disease area and therapeutic approaches relevant to the assigned programs
• Nonclinical and clinical drug discovery and development
• TMS state-of-the-art technologies
• Regional/global Regulatory requirements
• GCP/ICH 

 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $169.00/hr.