Job Closed

This listing is no longer active.

Medical Director, Patient Safety

Location

United States

Posted

64 days ago

Salary

$290K - $310K / year

Seniority

Lead

No structured requirement data.

Job Description

Medical Director, Patient Safety

Nuvation Bio

Role Description The Pharmacovigilance Physician will report to the VP of Pharmacovigilance. The PV/Drug Safety physician will be a medical professional responsible for ensuring drug safety throughout a product's lifecycle by detecting, assessing, and managing adverse events. They will conduct medical reviews of safety reports (ICSRs), identify risks, and ensure compliance with global regulations. You will be responsible for: - Providing clinical and scientific leadership within the pharmacovigilance function. - Engaging cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs. - Providing clinical input to the design of clinical trials, signal detection and management activities, post-authorization studies, risk minimization, and risk communication. - Performing case series analysis of adverse events and review of passive surveillance data mining signals of disproportionate reporting as well as safety issues from other sources. - Leading clinical safety and benefit-risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees. - Performing post-marketing surveillance and regulatory reporting, as needed. - Guiding the operations of contract research organizations. - Serving as an exemplary leader, mentor, and trainer. Qualifications - MD, D.O. or non-US equivalent required. - Residency training & board certification highly preferred. - Clinical practice experience highly preferred. - Experience working with public health agencies highly preferred. - 2-4 years of prior experience in pharmacovigilance in an industry setting, either in a comparable role, or in clinical development. Requirements - Proven ability to collaborate effectively within dynamic and fast-moving technical teams to deliver high-quality results within established timelines. - Utilize technology supporting pharmacovigilance (e.g. for signal detection and regulatory reporting). - Interpret and integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, government research organizations (e.g. NIH), public health agencies and nongovernmental organizations, and clinical practice groups. - Investigate new safety issues. - Communicate medical product benefits and risks to regulatory and public health authorities as well as the public. - Ability to thrive in a fast-paced environment while providing appropriate attention to detail. - Excellent analytical, problem-solving, strategic planning, and interpersonal skills. Behavioral skills to be successful... - Problem-Solver: As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges. - Personable: You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives. - Credible: With a thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource. - Emotional intelligence: Curiosity, and a knack to figure out a way to build something better. - Communication: Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders. - Accountability: Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity. - Adaptability: Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks. Benefits - Competitive Base Salary, Bonus, and Equity Plans. - Unlimited Vacation and 10 Sick Days Annually. - Excellent Medical, Dental, and Vision Coverage. - 401K with Company Matching. - And much more!

Related Categories

Related Job Pages

More Medical Director Jobs

UCB logo

Dermatology APP Medical Liaison - East

UCB

UCB, short for Union Chimique Belge, is a publicly traded, global pharmaceuticals company dedicated to making a difference for people around the world who are l

Medical Director64 days ago

Serve as a scientific partner to dermatology providers, conduct peer discussions, gather insights to inform medical strategy, and support educational initiatives aligned with innovative therapies for chronic skin conditions.

Remote
Full TimeRemoteTeam 501-1,000

About PharmaEssentia: It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together. PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung. Position Overview: The primary responsibility of a Medical Science Liaison (MSL) is the exchange of medical information with health care professionals (HCPs) involved with the management of myeloproliferative neoplasms (MPNs). As a key member of the Medical Affairs Team, you will facilitate and develop the relationship with the medical/scientific community including physicians and medical centers, by communicating product-related information to investigators and institutions. In addition, you will provide information on research developments, new clinical trials and new concepts in medical treatment, to bring our flagship product to market for the treatment of polycythemia vera (PV). The hired candidate must reside in the Chicago area. Key Responsibilities: - Establish a respectable PharmaEssentia presence in the medical community. - Identify and develop relationships with the medical community, thought leaders, and treatment advocates. - Liaise and support the development of key and regional opinion leaders within a broad customer segmentation (community clinics, integrated delivery networks (IDNs), academic centers, etc.). - Provide high quality medical and scientific support/communications to internal and external customers (e.g., advisory board meetings, regional training courses/workshops together with KOL/ROL, support of speakers with presentations and literature research) - Lead medical education (disease statement, guidelines, and product information upon FDA approval). - Manage studies and ensure that proposals are aligned with medical objectives within PharmaEssentia locally and globally. Ensure study projects are in line with commercial objectives. - Maintain a high level of scientific and technical expertise in hematology, oncology, and blood disorders. Develop and increase knowledge of medical literature. Prepare and present critical reviews of scientific publications and congresses, internally and externally. - Complete necessary documentation in order to ensure knowledge preservation (e.g., CRM reports). Utilize the necessary tools to develop and follow up on strategic measures (project plans). - Write and ensure timely submission of locally relevant abstracts at congresses. - Provide cross-functional support for Market Access and other Medical Affairs activities. - Monitor competitor activities and marketplace changes. Qualifications and Experience: - Advanced Degree Required (PhD, PharmD, or MD) - Experience in the pharmaceutical industry, including 3+ years in a field medical/MSL role - Broad knowledge of general medicine with a focus in hematology, oncology or interferons. - Knowledge in planning and execution of scientific studies and clinical trials - Ability to develop and maintain relationships with key thought-leaders. - Ability to introduce the disease state to the KOL community and articulate complex programs. - Development of product knowledge and knowledge of Company and science - Excellent writing and oral communication skills (including presentations) - Strong networking skills (includes internal teams) - On-time completion of goals with high-quality results - Project planning and execution - Quality of judgment and decision making - Initiative on addressing issues for the team (“roll up your sleeves attitude”) - Ability to maintain collaborative relationships within a dynamic team environment. - Adherence and compliance with all required regulatory and GCP guidelines. The expected base salary range for this position is $170,000 to $230,000. Salary offers are based on a wide range of factors including relevant skills, training, experience, education and geographical location. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible for short-term and long-term incentives. Benefits of working with our team: PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits: - Comprehensive medical coverage - Dental and vision coverage - Generous paid time-off - 401(k) retirement plan with competitive company match - Medical & Dependent Care Flexible Spending Account - Monthly cell phone reimbursement - Employee Assistance Program Benefits of working with our team: PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits: - Comprehensive medical coverage - Dental and vision coverage - Generous paid time-off - 401(k) retirement plan with competitive company match - Medical & Dependent Care Flexible Spending Account - Up to $150 monthly cell phone reimbursement - Employee Assistance Program - Free parking EEO Statement: At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies. At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer. https://us.pharmaessentia.com/careers/

North Dakota + 4 moreAll locations: North Dakota | South Dakota | Minnesota | Wisconsin | Illinois
$170K - $230K / year

Orthopedic or Spine Medical Director - Remote

UnitedHealth Group

UnitedHealth Group is a healthcare and well-being company that’s dedicated to improving the health outcomes of millions around the world. We are comprised of

Medical Director65 days ago

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together. As part of the Focus Claims Review team at Optum, the Medical Director provides leadership, organization, and direction for the claims review program. The Medical Director will participate in all aspects of claim review services including provider telephonic discussions and provider appeals. In addition, the Medical Director may also be asked to assist in the direction and oversight in the development and implementation of coding and procedures. You’ll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough challenges. Primary Responsibilities: - Remote Schedule: Monday through Friday, flexible 8 hr. shifts; no weekends - Reviews surgical & spinal claims for correct coding using clinical record - Participation in Training regarding URAC, NCQA, Regulatory Compliance, Confidentiality, Conflict of Interest, HIPAA, and department specific training as applicable - Discuss cases and clinical coding situations with treating providers telephonically during scheduled hours - Participates in periodic coding conferences / calls and in ongoing internal performance consistency reviews - Supports compliance with regulatory agency standards and requirements (e.g., CMS, NCQA, URAC, state / federal and third-party payers) - Provide Clinical support for staff that conduct initial reviews You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. Required Qualifications: - Current, active, and fully unrestricted medical license - Current board certification in Orthopedic Surgery - 5+ years of clinical experience in Orthopedic surgery; specialized in spinal surgery post residency - Proficient in MS Office (MS Word, Excel, and Power Point) Preferred Qualifications: - Experience in managed care - Experience with professional claim coding / claim coding reviews - Knowledge of claim coding resources and techniques - Proficient computer skills and ability to learn to use clinical and claims software - Proven excellent interpersonal skills and the ability to work over the telephone with other colleagues including physicians, nurses, PTs, OTs and other similar personnel *All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you’ll find a far-reaching choice of benefits and incentives. The salary for this role will range from $248,500.00 to $373,000.00 annually based on full-time employment. We comply with all minimum wage laws as applicable. Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants. At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission. UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

United States
$248K - $373K / year
PACS logo

Regional Director – Clinical Services

PACS

Healthcare Leadership Careers • Administrative Support Services • Management Advisory and Consulting

Medical Director65 days ago
Full TimeRemoteTeam 201-500H1B Sponsor

• Develop, implement, educate and monitor clinical programs that are intended to meet Professional Nursing Standard of Care and Nursing Standard of Practice. • Advise and support facilities in their efforts to comply with State and Federal Survey Regulations for Medicare and Medicaid Licensure and Certification. • Assist facilities in response to endemic, epidemic, & pandemic disease outbreaks. • Assist the Administrator and/or DON in writing plan of corrections (POC) and Allegation of Compliance (AOC) for any state and federal survey deficiencies cited. • Monitor facilities compliance with POC’s submitted to State Health Department (HD) for recertification of Medicare and Medicaid License. • Provide oversight for reportable events that are submitted to HD. • Provide training to facility Administration and/or staff as needed. • Conduct monthly Regional DON meetings for clinical program training and DON development. • Conduct visits to the facility to assess and train clinical staff. • Attend regional meetings and give clinical insight as requested by the RDO. • Develop Regional tracking and trending reports for clinical metrics regarding CMS 5-star rating. • Assist facilities in their clinical risk management efforts.

Maryland
Job Closed