Job title: Medical Director – 100% remote Duration: 12 months (possible extension)
Description: Per manager: "We are seeing a medical director with significant experience in Hematology related specialty, 3-5 years of drug development experience within the pharmaceutical industry, and prior experience with preparing and submitting regulatory filings and responding to queries from regulators.
OBJECTIVES:
The Associate Medical Director leads and drives strategy for the overal global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned company pipeline compounds.
Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions.
Applies clinical/medical decision making to clinical development issues.
This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction.
Success or failure directly translates to the ability of TGRD to meet its corporate goals and for company to have future commercial products.
ACCOUNTABILITIES: Clinical Development team participation and leadership
Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product.
May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy.
Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
Recommends scope, complexity and size, and influence the budget of all aspects of a program.
Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
Responsible for high impact global decisions:
Monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as go/no go? decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
A significant error in judgment may result in loss of approvability and commercial viability of a product.?
Synopsis / Protocol Development, Study Execution, & Study Interpretation
Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies.
Serves as an advisor to other clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies.
Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.
Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.?
Trial Medical Monitoring
Responsible for 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 Pharmacovigilance.
Oversees non-medical clinical scientists with respect to assessment of these issues.
Makes final decisions regarding study conduct related to scientific integrity.?
External Interactions
Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.
Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.?
Due Diligence, Business Development and Alliance Projects
Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities.
Assesses scientific, medical, 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 DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC.
Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve company's strategic goals while striving to maintain good working relationship between company and partner.?
Leadership, Task Force Participation, Upper Management Accountability
Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds.
May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC).
Lead TGRD internal teams and may lead global cross-functional teams, as appropriate.
Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.
Conducts performance reviews and drive goal setting and development planning.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: ?
MD, Board Certified in Oncology, or internationally recognized equivalent plus 5 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).
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
NDA/MAA/Submission experience preferred.
Management experience 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 Knowledge
Therapeutic area knowledge relevant to mechanism of action
Regional/global Regulatory requirements? GCP/ICH? Emerging research in designated therapeutic area
TRAVEL REQUIREMENTS:
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.? Requires approximately 15 - 25% travel.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
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.
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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: $150.00/hr.