Medical Safety Director remote jobs

Medical Director - Medicare Programs Remote | Approx. $300,000 base + significant bonus potential About the Opportunity: A leading national healthcare contractor is seeking a Medical Director to provide clinical leadership and decision-making support for Medicare operations. This position plays a critical role in developing and enforcing coverage determinations, reviewing complex claims, and promoting evidence-based medical policy. The role is ideal for a physician, especially those with a background in Physical Medicine and Rehabilitation (PM&R), who wishes to transition from direct patient care into a leadership position influencing medical necessity and healthcare compliance at scale. Key Responsibilities: Clinical Leadership: Provide medical expertise for claim reviews, appeals, and Medicare policy development. Serve as a subject matter expert across multiple specialties. Policy Development: Collaborate with the Centers for Medicare & Medicaid Services (CMS) and other contractors to create, revise, and maintain Local Coverage Determinations (LCDs) and related guidance. Program Integrity: Identify trends in billing or compliance issues and work with investigative teams to address improper claims. Medical Review & Appeals: Oversee quality assurance in pre- and post-payment medical review determinations and assist with administrative law proceedings when necessary. Provider Education: Lead outreach and training for healthcare providers and professional associations to ensure adherence to Medicare policies and evidence-based practices. Travel is minimal (approximately 3-4 weeks per year), and the position is fully remote with occasional in-person meetings or conferences. Required Qualifications: MD or DO from an accredited institution. Active, unrestricted medical license in at least one U.S. state (must be eligible for additional licensure where required). Board Certification in a specialty recognized by the American Board of Medical Specialties (minimum three years). At least three years of experience as an attending physician. Prior experience within the Medicare, health insurance, or utilization review environment. Strong understanding of clinical evidence evaluation and medical necessity determination within fee-for-service structures. Excellent communication and collaboration skills across technical, regulatory, and clinical teams. Computer proficiency (MS Office, data analysis tools, virtual collaboration platforms). Preferred Qualifications: Background in PM&R, Internal Medicine, Oncology, Radiology, Ophthalmology, or Infectious Disease. Five or more years of clinical practice experience. Prior experience as a Medical Director in a Medicare or commercial payer organization. Familiarity with HCPCS, CPT, and ICD-10 coding standards. Advanced degree or coursework in healthcare administration or systems management (MBA, MHA, MS). Experience performing systematic literature reviews or using GRADE methodology. Compensation & Benefits: Base salary: Approximately $300,000, flexible depending on experience. Bonus structure: Significant performance-based bonuses. Benefits: Comprehensive health coverage, generous retirement contributions, paid time off, and strong professional development support. Schedule: Full-time, remote position with flexible hours. Why Join: This is an opportunity to move beyond clinical work while continuing to make a direct impact on patient access and policy integrity at a national level. Join a mission-driven organization that values medical expertise, promotes collaboration, and advances fairness and compliance within the U.S. healthcare system.

Reports Jointly To: Chief Executive Officer and Chief Medical Officer Clinical Specialty: MD, Board Certified in Sports Medicine (primary board specialty flexible) ViewFi is a nationwide virtual musculoskeletal (MSK) practice bringing high-quality orthopedic, sports-medicine, and physical-therapy care directly to patients in both traditional and non-traditional markets. We serve a diverse set of partners including personal injury/med-legal groups, self-insured employers, risk-based payers, and digital health collaborators in the sports and fitness markets through technology enabled, evidence-based clinical care. We are redefining what excellent MSK care looks like in a virtual environment. Position Summary The Medical Director will serve as the clinical leader of ViewFi's physician team and a core partner to our physical therapy, product, operations, and business teams. This role requires a practicing, board-certified Sports Medicine physician who can balance patient care with 30-40% administrative/leadership responsibilities. The Medical Director will ensure clinical excellence, maintain high-quality and consistent clinical pathways, represent ViewFi as the medical voice of the organization, and advance the science and evidence behind virtual MSK care. Key Responsibilities Clinical Leadership & Oversight Lead, oversee, and support the national team of physicians delivering virtual MSK care. Maintain and update clinical pathways, treatment standards, and practice guidelines across all ViewFi service lines. Partner closely with the Physical Therapy leadership team to ensure integrated, cohesive care between MDs and PTs. Ensure consistent, high-quality clinical documentation, coding accuracy, and compliance across markets. Oversee peer review, quality assurance activities, and clinical performance metrics. Participate in recruitment, onboarding, and ongoing development of new clinicians. Patient Care (70-80%) Actively see patients in a virtual setting, providing MSK consults and follow-ups. Model best-in-class virtual care workflows and contribute to continuous improvement of the patient experience. Support escalated or complex cases requiring senior clinical judgment. Strategic & Administrative Leadership (20-30%) Serve as the medical voice of ViewFi at conferences, webinars, panels, and partner meetings. Collaborate with executive leadership on product development, new service lines, geographic expansion and clinical innovation initiatives. Guide medical input for payers, partners, self-insured employers, and med-legal groups. Participate in strategic planning related to national expansion, licensure strategy, and resource allocation. Work cross-functionally with operations and technology teams to enhance clinical workflows. Provide medical insight and feedback on ViewFi's technology roadmap, including clinical decision support, AI integration, and general telehealth tools. Research, Publishing & Thought Leadership Lead or collaborate on clinical research demonstrating the efficacy of virtual MSK care, including both MSK MD consults and virtual PT. Publish and present outcomes, case series, and efficacy studies at relevant medical and industry conferences. Help build ViewFi's reputation as the leader in evidence-based virtual MSK care. Quality, Compliance & Risk Management Ensure the practice meets state and federal clinical guidelines, telehealth regulations, and licensure requirements. Maintain oversight of clinical incident review processes, risk-mitigation protocols, and outcome tracking. Drive continuous improvement in clinical quality, patient safety, and service reliability. Qualifications MD with Board Certification in Sports Medicine (primary board: FM, IM, EM, PM&R, etc. is flexible). Multi-state licensure required; willingness to pursue additional licensure required. Minimum 10 years of clinical experience; virtual care experience strongly preferred. Demonstrated leadership experience in a clinical or medical director role. Strong collaboration skills with PTs, operational teams, and cross-functional partners. Excellent communication and presentation skills; comfortable representing ViewFi publicly. Passion for virtual care, musculoskeletal medicine, and innovative delivery models. What We Offer Opportunity to lead a national MSK practice at the forefront of technology enabled virtual healthcare Collaborative environment with clinical and operational teams aligned around quality care and aggressive growth Competitive compensation with protected administrative time Support for conference travel, research, publishing, and clinical innovation Commitment to clinical excellence, patient outcomes, and provider support

Spectrum Healthcare Resources is excited to offer a potential career opportunity for a Behavioral Health Medical Director supporting the TriCare/Department of Defense and Community Care Network/Department of Veterans Affairs. This remote-based civilian position is an outstanding chance to make a meaningful contribution to the healthcare of veterans and military beneficiaries while benefiting from work-life flexibility, professional collaboration, and impactful leadership. Join us in leading high-quality care initiatives for those who have served our country, with a focus on system-wide clinical improvement, peer collaboration, and mission-driven support! Requirements: Doctor of Medicine (MD) or Doctor of Osteopathy (DO) from an accredited medical school. Active, unrestricted license to practice medicine in the United States. Board certification or board eligibility through a recognized specialty board. U.S. Citizenship. Favorable background investigation through the Department of Defense (DoD). Minimum of 5 years of medical practice experience. 3+ years of experience in managed care environments.

Alignment Health is breaking the mold in conventional health care, committed to serving seniors and those who need it most: the chronically ill and frail. It takes an entire team of passionate and caring people, united in our mission to put the senior first. We have built a team of talented and experienced people who are passionate about transforming the lives of the seniors we serve. In this fast-growing company, you will find ample room for growth and innovation alongside the Alignment Health community. Working at Alignment Health provides an opportunity to do work that really matters, not only changing lives but saving them. Together. Inpatient Utilization Management Medical Director works with Senior Medical Officers, Regional Medical Officers, Extensivists, the Healthcare Services Team (Case managers, Social Workers, Utilization Managers) to develop and implement methods to optimize use of Institutional and Outpatient services for all patients while also ensuring the quality of care provided. Through remote access to our web-based Portal, physician advisors will complete clinical reviews for medical necessity, treatment appropriateness and compliance. GENERAL DUTIES/RESPONSIBILITIES: Perform medical necessity utilization reviews primarily for inpatient and post-acute cases with some outpatient / pre-service reviews as needed in accordance with UM guidelines Lead concurrent review activities, including rounds, peer-to-peers, and utilization management strategies to improve clinical and efficiency outcomes Serve as a clinical leader and educator for the nursing / care management team Process claims reviews, appeals, and second-level reviews as needed in compliance with Medicare (NCD, LCD), internal, and third-party guidelines (e.g., MCG) for Inpatient, Outpatient, Skilled Facilities Level of Care and Pharmacy. Acts as a liaison between the medical staff, utilization review team, and 3rd parties to effectively promote clinically necessary and efficient utilization of care Serves as a Physician member of the utilization review team. Work with Interdisciplinary Teams to help manage complex or high risk cases Contributes to development of clinical strategies to improve member outcomes, efficiency metrics, and quality outcomes Duties may include serving on committees as needed, such as quality, utilization management, credentialing, etc Other duties as may be assigned to the medical director. Supervisory Responsibilities: Oversees assigned staff, if any. Responsibilities may include recruiting, selecting, orienting, and training employees; assigning workload; planning, monitoring, and appraising job results; and coaching, counseling, and disciplining employees. Experience: • Required: Minimum of 3 years of experience in hospital-wide or skilled nursing facility position involving clinical care, quality management, utilization / case management, or medical staff governance required • Preferred: Experience as a Physician Advisor or Medical Director a plus Education: Required: Completion of medical school and specialty residency (preferably in internal medicine). Preferred: Board-certification Specialized Skills: • Required: Ability to build rapport with medical staff and management leadership to obtain necessary approvals of new strategies for utilization management. Knowledge of current medical literature, research methodology, healthcare delivery systems, healthcare financial/reimbursement issues, and medical staff organizations. Dedication to the delivery of high-quality, cost-effective, efficient patient care services Effective written and oral communication skills; ability to establish and maintain a constructive relationship with diverse members, management, employees and vendors; Mathematical Skills: Ability to perform mathematical calculations and calculate simple statistics correctly Reasoning Skills: Ability to prioritize multiple tasks; advanced problem-solving; ability to use advanced reasoning to define problems, collect data, establish facts, draw valid conclusions, and design, implement and manage appropriate resolution. Problem-Solving Skills: Effective problem solving, organizational and time management skills and ability to work in a fast-paced environment. Licensure: • Required: Applicants must have current, non-restricted licensure as required for clinical practice in the state of California. Work Environment: This is a remote position. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential Physical Functions: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 1 While performing the duties of this job, the employee is regularly required to talk or hear. 2 The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms. 3 The employee frequently lifts and/or moves up to 10 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus. Pay Range: Pay range may be based on a number of factors including market location, education, responsibilities, experience, etc. Alignment Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity, or sexual orientation. *DISCLAIMER: Please beware of recruitment phishing scams affecting Alignment Health and other employers where individuals receive fraudulent employment-related offers in exchange for money or other sensitive personal information. Please be advised that Alignment Health and its subsidiaries will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for employment with our company. If you feel that you have been the victim of a scam such as this, please report the incident to the Federal Trade Commission at ******************************* If you would like to verify the legitimacy of an email sent by or on behalf of Alignment Health's talent acquisition team, please email ******************.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Location/Division Specific Information: Join Thermo Fisher Scientific as a Global Medical Safety Lead Physician(FSP) based in the United States and be part of a world-class organization conducting groundbreaking research. Ideal candidate location is Eastern or Central Time Zone. This position is fully remote, benefit eligible with travel in a 10-20% range(international maybe required). *Must be legally authorized to work in the United States without sponsorship. Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you're looking for a place where your work, in partnership with others, can have real impact-and where you're encouraged to challenge yourself and contribute to breakthrough solutions , the Global Medical Safety Lead could be a great fit. Purpose of the Function: Lead and perform the assessment of medical safety data for assigned products Develop and execute safety signaling and benefit-risk management strategies Closely collaborate with stakeholders internally (e.g. Regulatory Affairs, clinical development, medical affairs) and externally (e.g. Key Opinion Leaders or regulatory agencies) to align safety communications and to ensure the safe use of the client's products Roles and Responsibilities: Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s) Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s) Contribute to the development of the overall safety governance structure and activities Provide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s) Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs) Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents Oversee the medical assessment of individual case safety reports (ICSR) Confirm criteria and content for expedited reporting and unbinding (e.g. SUSAR or urgent safety issues) Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB) Provide medical safety contributions at internal audits and regulatory inspections Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates) Support adverse event reporting training and pharmacovigilance awareness activities cross functionally Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners Participate in cross-functional teams and initiatives Education, Experience and Qualifications: MD degree or equivalent required At least 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus) At least 1 year of experience in clinical practice or in academic medicine Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents Demonstrated ability to perform medical assessments of safety data from multiple sources Experience with authoring complex documents and contributing to regulatory submissions Knowledge of adverse event reporting systems Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus Skills and Competencies: Strong scientific and analytic skills Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams Excellent presentation skills with the ability to communicate complex issues clearly Relevant computer skills, including proficiency with Microsoft Office Physical Requirements / Work Environment Work is performed in an office environment with exposure to electrical office equipment Occasional drives to site locations with occasional travel both domestic and international Frequently stationary for 6-8 hours per day Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists Frequent mobility required Occasional crouching, stooping, bending and twisting of upper body and neck Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences Frequently interacts with others to obtain or relate information to diverse groups Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task Regular and consistent attendance Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary Under supervision of the VP, Head of Medical Safety & Pharmacovigilance, and as per company policies and procedures, the Medical Director, Safety Evaluation & Risk Management (Neuromuscular) will be responsible for strategic and innovative medical leadership for Clinical Safety, Pharmacovigilance and Risk Management activities for assigned AskBio investigational products. This individual will function in a matrix team environment interacting with several key internal stakeholder groups including Clinical Development Medical Affairs, Regulatory Affairs, Product Quality Compliance, Quality Assurance, Translational Medicine etc. Job Responsibilities Represent Medical Safety & Pharmacovigilance in Clinical Teams for assigned investigational products providing medical guidance in planning and gaining alignment for all safety matters and issues Lead Safety Management Team(s) navigating complex safety issues for assigned Investigational product(s) and responsible for all associated risk management activities, including regular review of safety data for identification and evaluation of new safety signals Provide safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs/IDMC Charters Provide/oversee medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database Provide input in responding to and resolving safety questions from regulatory authorities Provide input/oversee production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide Minimum Requirements Advanced medical degree (e.g., MD, MBBS, DO) 5+ years of relevant experience in drug safety, pharmacovigilance, and/or clinical research, including 3+ years working as a Safety Physician in the clinical safety department of a biopharmaceutical company Experience should include safety risk management, pharmacovigilance, and/or clinical research with exposure to clinical data collection, assessment, and analysis Good working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines Strong interpersonal skills with ability to facilitate collaboration across functions to reach consensus on safety topics Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications Excellent written and spoken English Preferred Education, Experience and Skills Prior gene therapy safety experience Neurology and/or neuromuscular therapeutic experience AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at ******************. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The Sr. Medical Director, Drug Safety, is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators. Oversight and understanding of all aspects of the assigned product's safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data Chair of the Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries Responsibilities Support the clinical development team in the review of key documents, including protocol and ICFs Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities Assist in the authoring of aggregate reports Where You'll Work This a U.S-based remote role that will generally require three visits per year, or as needed visits to our San Francisco Office. Who You Are Medical Degree Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least two years of oversight management experience (line management or CSO management) Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates. Experience in both clinical development and post-marketing safety Experience with Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews Demonstrated ability to successfully manage a drug safety team or drug safety CRO for a clinical development program with responsibilities for expedited reporting, on-time DSUR preparation Experience in drug safety audits and agency inspections Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA Experience in managing all clinical safety aspects of product quality defect investigations and assessments Management of compliance deviations and formulation of CAPAs Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook) Must be able and willing to travel periodically for face-to-face engagements with regulatory authorities, and occasional on-site meetings (if based remotely) Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities #LI-NT1 At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$310,000-$340,000 USD

Site: Mass General Brigham Health Plan Holding Company, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Mass General Brigham Health Plan is an exciting place to be within the healthcare industry. As a member of Mass General Brigham, we are on the forefront of transformation with one of the world's leading integrated healthcare systems. Together, we are providing our members with innovative solutions centered on their health needs to expand access to seamless and affordable care and coverage. Our work centers on creating an exceptional member experience - a commitment that starts with our employees. Working with some of the most accomplished professionals in healthcare today, our employees have opportunities to learn and contribute expertise within a consciously inclusive environment where diversity is celebrated. We are pleased to offer competitive salaries, and a benefits package with flexible work options, career growth opportunities, and much more. Under the direction of the Senior Medical Director, the Medical Director leads as a senior physician at the health plan. This position works closely with the Senior Medical Director in providing medical management leadership for clinical services operations and programs. This role focuses on and has expertise in utilization management, health plan quality and accreditation, care management, and other health plan functions. Qualifications Licensure and Credentials: Must maintain an active full physician license in Massachusetts Experience: 3-5 years of Health Plan experience at least 5 years of clinical practice experience Job Duties: Handles utilization management initial determinations, appeals and grievances within the scope of their expertise as defined by Medicare, MassHealth, NCQA and the Division of Insurance and within the compliance requirements of key regulatory and accreditation entities •Reviews clinical services and quality incidents when sufficiently serious to merit physician involvement •Coverage of medical necessity determinations to support special investigations/fraud waste and abuse cases •Collaborates on health plan medical policy development •Assesses new, emerging, and existing technologies to determine appropriateness of health plan coverage •Partners with clinical leaders to ensure medical service expenditures remain within budget •Collaborates with business development, quality, finance and medical management teams to promote improvements in the quality and cost efficiency of care throughout the MGB Health Plan provider network •Delivers consultation to network management staff and deployment of education programs for network clinicians •Develops and delivers presentations for clinical staff on current topics relevant to MGB Health Plan members and network •May represent MGB Health Plan at a variety of external forums and committees •Interact, communicate and collaborate with network and community physicians, hospital leaders and other vendors regarding care and services for enrollees •Monitors performance metrics and audits to identify areas for continuous improvement and ensure compliance •Anticipates and meets or exceeds internal and/or external customer expectations and requirements; establishes and maintains positive relationships with customers and gains their trust and respect •Build strong relationships and infrastructure that designate MGB Health Plan as a people-first organization •Ensure diversity, equity and inclusion are integrated as a guiding principle •Other duties as assigned with or without accommodation Additional Job Details (if applicable) Primarily remote position, exempt •In person meetings as requested for business needs •Participates in after hours and weekend call rotation as assigned Remote Type Remote Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) EEO Statement: Mass General Brigham Health Plan Holding Company, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

HealthPartners is looking for Medical Director to join our Home-Based Medicine team. This role will be a 1.0 FTE with 0.30 FTE dedicated to the medical director role and 0.70 dedicated to clinical. This is a unique opportunity to make a meaningful impact on the lives of patients with advanced illness by shaping the future of care delivered in the home. The Medical Director of Home-Based Medicine (HBM) will provide clinical and operational leadership across HealthPartners' innovative home-based care programs. You'll help define and guide best practices, scope of care, and clinical quality across multiple care pathways, including Home Based Primary Care, In Home Complex Care and Transitional Visits. This work is being done in close collaboration with the Advance Care Primary Care (ACPC) clinic, as well as many other departments caring for patients with advanced illness in this space. In addition to leadership responsibilities, the Medical Director will dedicate a portion of their time to direct patient care, primarily in the home setting, with a smaller portion of clinical work occurring in the Advanced Care Primary Care (ACPC) Clinic. You will be joining a team that is supportive and respectful of one another and deeply committed to the mission of HealthPartners. Here, you'll become a partner for good, helping to improve the health and well-being of our patients, members and community. Our commitment to excellence, compassion, partnership and integrity is behind everything we do. It's the type of work that makes a difference, the kind of work you can be proud of. We hope you'll join us. QUALIFICATIONS: The position requires board eligibility/board certification, preferably in Hospice and Palliative Care, Internal Medicine, or Family Medicine. Preferred candidates will have a minimum of 2 years leadership/administrative experience and demonstrate ongoing commitment to leadership development. The ideal candidate will have a deep understanding of innovative care models for complex patients within a diverse clinical setting. BENEFITS: HealthPartners benefit offerings (for 0.5 FTE or greater) include medical insurance, dental insurance, 401k with company contribution and match, 457(b) with company contribution, life insurance, AD&D insurance, disability insurance, malpractice insurance for work done on behalf of HealthPartners as well as a CME reimbursement account. Our clinician well-being program provides a wealth of information, tools, and resources tailored to meet the unique needs of our health care professionals, including physicians, advanced practice clinicians (APCs) and dentists. HealthPartners is a qualified non-profit employer under the federal Public Service Loan Forgiveness program. TO APPLY: For more information about the position or to apply, please contact Judy Brown, Sr. Physician and APC Recruiter at *********************************. For immediate consideration, please apply online.

Millions of people around the world come to our platform to find creative ideas, dream about new possibilities and plan for memories that will last a lifetime. At Pinterest, we're on a mission to bring everyone the inspiration to create a life they love, and that starts with the people behind the product. Discover a career where you ignite innovation for millions, transform passion into growth opportunities, celebrate each other's unique experiences and embrace the flexibility to do your best work. Creating a career you love? It's Possible. We're looking for a strong Safety Specialist to join our Content Operations team - responsible for the enforcement of our content policies under our Community Guidelines and Advertising Guidelines. This role will be part of our Trust and Safety Enforcement Operations organization and will be an impactful member of the team interacting directly with Pinners and partners to support content enforcement related inquiries and requests. In addition, you'll leverage critical thinking and insights to improve our operational processes and policies while working closely with cross-functional partners to develop and support team goals and projects. In this role you'll build familiarity with our escalation procedures, test and improve our tools and best practices, provide relevant context and feedback to teams building new features, and build relationships with the other teams who help keep Pinterest safe. What you'll do: Independently develop, monitor, interpret, and understand policies and procedures, while ensuring they match organizational strategies and objectives focused around our Hateful Activities (Hate Speech) and Graphic Violence policies Accountable for content moderation processes within our Critical Harms pod, utilizing a strong understanding of relevant policies and procedures to ensure prevention of harmful content on Pinterest Uses policy proficiency to perform content moderation, make enforcement decisions, take enforcement actions, and influence scaled content moderation efforts Responsible for the oversight and execution of BPO KPIs such as quality scores and turnaround times for Critical Harms workflows, providing insights and clarifications to mitigate quality gaps with both vendor and internal teams Identify gaps and trends in content workflows to make recommendations for risk mitigation Collaborate cross-functionally to improve processes and support projects and act as a point of contact for cross-functional partners Embrace ambiguity, change, and a growth mindset Resolve escalations and focus on remediations to operational processes, procedures, and policy gaps What we're looking for: College degree in a relevant field such as business, economics, law, public policy or equivalent experience 5+ years experience in the tech industry working in the enforcement / Spam space Demonstrated strong experience in an operational and/or support role Experience working with outsourcing teams / scaled support A customer-focused individual who shows inquisitiveness: you put Pinners and Partners first and propose solutions that provide a safer experience for both Strong critical thinking skills and the ability to evaluate issues objectively Demonstrated experience working on multiple projects simultaneously; remains focused and productive A strong communicator that can confidently present learnings and influence stakeholders using data-driven solutions Relocation Statement: This position is not eligible for relocation assistance. Visit our PinFlex page to learn more about our working model. In-Office Requirement Statement: We let the type of work you do guide the collaboration style. That means we're not always working in an office, but we continue to gather for key moments of collaboration and connection. This role will need to be in the office for in-person collaboration 1 time per half and therefore can be situated anywhere in the country. #LI-REMOTE #LI-PW1 At Pinterest we believe the workplace should be equitable, inclusive, and inspiring for every employee. In an effort to provide greater transparency, we are sharing the base salary range for this position. The position is also eligible for equity. Final salary is based on a number of factors including location, travel, relevant prior experience, or particular skills and expertise. Information regarding the culture at Pinterest and benefits available for this position can be found here. US based applicants only$81,921-$168,660 USD Our Commitment to Inclusion: Pinterest is an equal opportunity employer and makes employment decisions on the basis of merit. We want to have the best qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, color, ancestry, national origin, religion or religious creed, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, age, marital status, status as a protected veteran, physical or mental disability, medical condition, genetic information or characteristics (or those of a family member) or any other consideration made unlawful by applicable federal, state or local laws. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. If you require a medical or religious accommodation during the job application process, please complete this form for support.

BRIEF DESCRIPTION: The Director of Safety will ensure a high level of governance and operating compliance in BluSky safety and emergency planning, in close partnership with BluSky Field Operations. The individual plans, implements, and supervises all project safety, general corporate safety, and risk control activities. The Director of Safety leads a team that provides safety guidance and support to all operations business units in order to deliver an overall reduction of operating risk, underpin safety performance improvement and ensure compliance. Promotes a positive attitude of safety throughout the company's employees and subcontractors. Represents BluSky in accordance with corporate values. Salary Range: $140,000 - $160,000 Bonus Potential: 10% PRINCIPAL DUTIES & RESPONSIBILITIES: Supervises, coaches, and trains BluSky safety personnel. Develops enterprise wide strategy for ensuring project safety compliance and risk control activities. Lead development of and clearly articulate Company's safety vision, objectives, strategies, policies, and procedures. Develops and monitors site-specific safety and risk control planning for all projects. Manages accidents, injuries, risks, or claims to ensure minimum impact to the company. Promotes a positive attitude of safety throughout the company's employees and subcontractors. Identifies employee safety, subcontractor safety, and public safety concerns with projects, and provides a plan to manage risks related to those concerns. Attends job review meetings to discuss the safety and risk control plan and its implementation and success. Develops and executes the BluSky Safety Auditing Program to aid in preventing conditions that can result in injury or loss. Regular reporting on the State of Safety to local, regional, and executive team on the success of the overall corporate and project safety and risk control plan. Promptly investigates claims or injuries, handles immediate needs and investigation, and follows through to minimize exposure to the company and preservation of the company's safety record (i.e., no lost time, no large claims etc.). Respond immediately to calls regarding accidents, injuries, losses, claims, or safety concerns. Manage submitted claims (Workers Compensation, General Liability) to mitigate risk to BluSky and to build preventative actions. Ensures that required safety and risk control records and reports are complete, accurate and submitted for all projects and the corporate offices. Reviews incidents and losses with the project team to help prevent future claims or accidents. Submits required reports by OSHA and other government entities. Represents the Company with government agencies. Reviews insurance company-provided risk control reports to verify accuracy. Works with the insurance providers to correct any discrepancies. Exemplifies the standards and importance of safety through example and deed. Performs other duties as required to ensure overall corporate and project safety with minimal risks and insurance costs. Regular, timely, and predictable attendance is required for this position. Manage licensing portfolio (business, contracting, environmental) for the enterprise. Performs other duties and responsibilities as assigned. Additional Duties & Responsibilities Develops and performs safety training to ensure employee awareness and compliance with regulations. Develops and performs safety training for supervisory personnel. SUPERVISORY RESPONSIBILITY: This role has direct reports. QUALIFICATIONS & REQUIREMENTS: OSHA 500 preferred. Available 24 hours, 7 days a week to facilitate accidents, injuries, or losses wherever they may occur for the company. Driver's license with an acceptable motor vehicle driving record. U.S. Citizenship required for certain federal projects. In depth technical knowledge of construction related OSHA, federal, state, and local regulatory standards, and ability to recognize hazardous situations and implement effective corrective practices. Ability to interact and communicate effectively with customers, vendors, and employees at all levels of the organization. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Ability to effectively lead and manage teams. Ability to proactively plan for any risks and activities to help meet or exceed the deadline. Ability to maintain confidentiality and professionalism in the workplace. Possess strong computer skills; proficient in MS Excel, MS Word and MS Outlook. EDUCATION: Bachelor's Degree in environmental health & safety, safety management, or Industrial Health & Safety with 10 years construction industry safety management experience, or 15 years of progressive experience in related industry safety and health supervision. Degree or Certified Safety Professional (CSP) Credential is preferred, but not required. TRAVEL: Travel 30% to 50% of the time. Some out-of-area and overnight travel may be expected for training or meetings. WORK ENVIRONMENT & PHYSICAL JOB DEMANDS: The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. These must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment can range from quiet to significantly loud. The employee must regularly lift and/or move between 25-50 pounds. While performing the duties of this job, the employee is regularly required to stand, walk, use hands and fingers to handle material, reach with hands and arms, and talk and hear. The employee is required to regularly move and walk around the office. COMPENSATION: BluSky provides a competitive base salary, a bonus plan, travel per diem, and a comprehensive benefits package that includes: a matching 401(k) plan with guaranteed match, health insurance plans (medical, dental, and vision), unlimited paid time off (for this position), paid holidays, disability coverage, job-specific equipment (e.g., laptop, smartphone, etc.), and a corporate apparel allowance. BluSky also offers extended benefits such as: an Employee Assistance Program, Accident and Critical Illness Coverage, LegalShield, Professional Development Opportunities, a Paid Employee Referral Program, Vendor discounts, and much more. EEOC: BluSky is dedicated to the principles of equal employment opportunity. BluSky prohibits unlawful discrimination against applicants or employees based on age 40 or over, race, sex, color, religion, national origin, disability, genetic information, sexual orientation, or any other applicable status protected by Federal, State, or local law. It is and will continue to be the policy of BluSky that all people are entitled to equal employment opportunity based on their individual qualifications, performance, and potential without regard for any protected status, as required by state and federal law. Application Duration: To ensure a thorough and fair selection process, we would like to inform you that the application deadline for this position is 14 days from the posting date. Please ensure that your application is submitted by this date for consideration. To be considered for this position, you must complete the online application by visiting our careers page at *************************

BRIEF DESCRIPTION: The Director of Safety will ensure a high level of governance and operating compliance in BluSky safety and emergency planning, in close partnership with BluSky Field Operations. The individual plans, implements, and supervises all project safety, general corporate safety, and risk control activities. The Director of Safety leads a team that provides safety guidance and support to all operations business units in order to deliver an overall reduction of operating risk, underpin safety performance improvement and ensure compliance. Promotes a positive attitude of safety throughout the company's employees and subcontractors. Represents BluSky in accordance with corporate values. Salary Range: $140,000 - $160,000 Bonus Potential: 10% PRINCIPAL DUTIES & RESPONSIBILITIES: Supervises, coaches, and trains BluSky safety personnel. Develops enterprise wide strategy for ensuring project safety compliance and risk control activities. Lead development of and clearly articulate Company's safety vision, objectives, strategies, policies, and procedures. Develops and monitors site-specific safety and risk control planning for all projects. Manages accidents, injuries, risks, or claims to ensure minimum impact to the company. Promotes a positive attitude of safety throughout the company's employees and subcontractors. Identifies employee safety, subcontractor safety, and public safety concerns with projects, and provides a plan to manage risks related to those concerns. Attends job review meetings to discuss the safety and risk control plan and its implementation and success. Develops and executes the BluSky Safety Auditing Program to aid in preventing conditions that can result in injury or loss. Regular reporting on the State of Safety to local, regional, and executive team on the success of the overall corporate and project safety and risk control plan. Promptly investigates claims or injuries, handles immediate needs and investigation, and follows through to minimize exposure to the company and preservation of the company's safety record (i.e., no lost time, no large claims etc.). Respond immediately to calls regarding accidents, injuries, losses, claims, or safety concerns. Manage submitted claims (Workers Compensation, General Liability) to mitigate risk to BluSky and to build preventative actions. Ensures that required safety and risk control records and reports are complete, accurate and submitted for all projects and the corporate offices. Reviews incidents and losses with the project team to help prevent future claims or accidents. Submits required reports by OSHA and other government entities. Represents the Company with government agencies. Reviews insurance company-provided risk control reports to verify accuracy. Works with the insurance providers to correct any discrepancies. Exemplifies the standards and importance of safety through example and deed. Performs other duties as required to ensure overall corporate and project safety with minimal risks and insurance costs. Regular, timely, and predictable attendance is required for this position. Manage licensing portfolio (business, contracting, environmental) for the enterprise. Performs other duties and responsibilities as assigned. Additional Duties & Responsibilities Develops and performs safety training to ensure employee awareness and compliance with regulations. Develops and performs safety training for supervisory personnel. SUPERVISORY RESPONSIBILITY: This role has direct reports. QUALIFICATIONS & REQUIREMENTS: OSHA 500 preferred. Available 24 hours, 7 days a week to facilitate accidents, injuries, or losses wherever they may occur for the company. Driver's license with an acceptable motor vehicle driving record. U.S. Citizenship required for certain federal projects. In depth technical knowledge of construction related OSHA, federal, state, and local regulatory standards, and ability to recognize hazardous situations and implement effective corrective practices. Ability to interact and communicate effectively with customers, vendors, and employees at all levels of the organization. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Ability to effectively lead and manage teams. Ability to proactively plan for any risks and activities to help meet or exceed the deadline. Ability to maintain confidentiality and professionalism in the workplace. Possess strong computer skills; proficient in MS Excel, MS Word and MS Outlook. EDUCATION: Bachelor's Degree in environmental health & safety, safety management, or Industrial Health & Safety with 10 years construction industry safety management experience, or 15 years of progressive experience in related industry safety and health supervision. Degree or Certified Safety Professional (CSP) Credential is preferred, but not required. TRAVEL: Travel 30% to 50% of the time. Some out-of-area and overnight travel may be expected for training or meetings. WORK ENVIRONMENT & PHYSICAL JOB DEMANDS: The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. These must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment can range from quiet to significantly loud. The employee must regularly lift and/or move between 25-50 pounds. While performing the duties of this job, the employee is regularly required to stand, walk, use hands and fingers to handle material, reach with hands and arms, and talk and hear. The employee is required to regularly move and walk around the office. COMPENSATION: BluSky provides a competitive base salary, a bonus plan, travel per diem, and a comprehensive benefits package that includes: a matching 401(k) plan with guaranteed match, health insurance plans (medical, dental, and vision), unlimited paid time off (for this position), paid holidays, disability coverage, job-specific equipment (e.g., laptop, smartphone, etc.), and a corporate apparel allowance. BluSky also offers extended benefits such as: an Employee Assistance Program, Accident and Critical Illness Coverage, LegalShield, Professional Development Opportunities, a Paid Employee Referral Program, Vendor discounts, and much more. EEOC: BluSky is dedicated to the principles of equal employment opportunity. BluSky prohibits unlawful discrimination against applicants or employees based on age 40 or over, race, sex, color, religion, national origin, disability, genetic information, sexual orientation, or any other applicable status protected by Federal, State, or local law. It is and will continue to be the policy of BluSky that all people are entitled to equal employment opportunity based on their individual qualifications, performance, and potential without regard for any protected status, as required by state and federal law. Application Duration: To ensure a thorough and fair selection process, we would like to inform you that the application deadline for this position is 14 days from the posting date. Please ensure that your application is submitted by this date for consideration. To be considered for this position, you must complete the online application by visiting our careers page at *************************

The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified. Candidate may reside in one of these areas: Denver, CO; St. Louis, MO; Minneapolis, MN. Territory covers: WY, CO, NM, ND, SD, NE, KS, MN, IA, MO, IL, IN Responsibilities Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience. Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information. Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups. Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs). Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc. Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development As identified, contribute to internal training for headquarter- and field-based teams and supporting speaker training initiatives. Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes. Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends. Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications. Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested. Performing and completing administrative responsibilities, including reporting requirements in a timely fashion Qualifications Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed] Active clinical care, clinical research, or academia experience preferred Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care. Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred. Competencies: Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter. Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Approximately 60% overnight travel The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Medical Affairs Strategy Director, IP&SS 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You'll Make in this Role The Medical Affairs Strategy Director for the Infection Prevention & Surgical Solutions (IP&SS) will be the key point of contact between Medical Affairs and the IP&SS leadership team, Corporate Strategy, Regulatory/Quality, and Laboratory leadership to ensure alignment of MA activities with IP&SS global and regional strategies and plans. The leader will own the governance process to ensure a fully integrated Medical Affairs strategy and upstream and downstream activities for the IP&SS portfolio, aligning all Medical Affairs subfunctions and capabilities (evidence plans, scientific exchange, and medical governance & field medical activities, etc.) to ensure therapy adoption to address unmet medical and customer needs while enabling regional adaptation. As the Medical Affairs Strategy Director for IP&SS you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here you will make an impact by: Set and maintain the integrated Medical Affairs strategy, by portfolio and area, based on priorities and resourcing. Including Chairing MA strategy reviews; ensure global and regional alignment and trade‑off clarity. Serve as the internal liaison to group leaders in within IP&SS commercial functions, Chief Medical Officer, VP of Strategy and Operations, and all medical affairs sub functions to ensure alignment, prioritization and success Own the Medical Affairs & IP&SS business cadence (monthly/quarterly), including dashboards, decision logs, risk registers, and escalations. Define, track, and continuously improve Medical Affairs KPIs tied to readiness and growth (e.g., publications on plan, MSL readiness/coverage, content cycle‑time, scientific exchange reach/quality, KOL activation). Translate business goals into an evidence roadmap with Clinical Affairs, Scientific Affairs, Medical Directors and Healthcare Economics and Outcomes Research; sequence activities to meet claim/launch objectives Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor's Degree or higher (completed and verified prior to start) AND ten (10) years of experience in the med device, med tech, or pharmaceutical industry Additional qualifications that could help you succeed even further in this role include: Advanced clinical/scientific/business degree from an accredited institution (MD/PhD/PharmD preferred or Master's/MBA Degree with significant Medical Affairs leadership) Five (5) or more years of experience in Medical Affairs/MedTech with multi‑portfolio launch leadership; track record of establishing governance, operating rhythms, and cross‑functional curriculum frameworks that scale. Demonstrated influence at segment/enterprise forums (CRR/portfolio reviews), with proven ability to resolve cross‑functional trade‑offs. Fluency in evidence planning, scientific exchange, compliance fundamentals, KPI design, and change leadership. People leadership experience (direct or large matrix) and budget stewardship for MA strategic initiatives. Work location: Remote - United States Travel: May include up to 30% domestic/international Relocation Assistance: Not authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $222,044 - $271,387, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.

Career CategorySafetyJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Medical Director - Hematology/Oncology What you will do Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed. Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Experience in the study/research and/or treatment of Oncology disease states What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 243,245.00 USD - 319,267.00 USD

The Medical Director is responsible for supporting staff by providing training, clinical consultation, and clinical case review for members. Essential Functions: Provide prior authorization medical reviews, consultation and clinical review services Participate in peer-to-peer discussions Provide provider education, training, data sharing, performance evaluations and orientation to the plan Conduct clinical reviews for designated CareSource members as requested Provide physician review for clinical appeals cases Participate in the evaluation and investigations of cases suspected of fraud, abuse, and quality of care concerns Participate in development of policies and procedures Participates in quality improvement initiatives, case management activities and member safety activities (i.e. incident management Provide cross-coverage for other Medical Directors and/or markets, as needed Oversight and quality improvement activities associated with case management activities Assist in the review of utilization data to identify variances in patterns, and provide feedback and education to MCP staff and providers as appropriate Participate in the development, implementation and revision of the clinical care standards and practice guidelines ensuring compliance with nationally accepted quality standards Participate in the development, implementation and revision of the Quality Improvement Plan and corporate level quality initiatives Collaborate with market/product leaders to help define market strategy Community collaborative participation Support of regulatory and accreditation functions (eg. CMS, State, NCQA and URAC) and compliance for all programs Perform any other job related instructions, as requested Education and Experience: Completion of an accredited Medical Degree program as a medical doctor (MD) or Doctor of Osteopathic (DO) medicine is required Successful completion of a residency training program, preferably in primary care is required Minimum of five (5) years of clinical practice experience is required Managed care medical review/medical director experience is preferred Bachelor's or Master's degree in Business Administration, Operational Excellence, Healthcare Administration or Medical Management is preferred Competencies, Knowledge and Skills: Basic Microsoft Word skills Excellent communication skills, both written and oral Ability to work well independently and within a team environment Ability to create strong relationships with Providers and Members High ethical standards Attention to detail Critical listening and systematic thinking skills Ability to maintain confidentiality and act in the company's best interest Ability to act with diplomacy and sensitivity to cultural diversity Decision making/problem solving skills Conflict resolution skills Strong sense of mission and commitment of time, effort and resources to the betterment of the communities served Licensure and Certification: Current, unrestricted license to practice medicine in state of practice as necessary to meet regulatory requirements is required Board Certification, preferably in primary care specialty is required Re-certification, as required by specialty board, must be maintained (exceptions may be granted by Chief Medical Officer) MCG Certification is required or must be obtained within six (6) months of hire Working Conditions: General office environment; may be required to sit or stand for extended periods of time May be required to work evenings/weekends May be required to travel to fulfill duties of position Compensation Range: $191,400.00 - $334,900.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. Compensation Type (hourly/salary): Salary Organization Level Competencies Fostering a Collaborative Workplace Culture Cultivate Partnerships Develop Self and Others Drive Execution Influence Others Pursue Personal Excellence Understand the Business This is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an environment of belonging that welcomes and supports individuals of all backgrounds.#LI-SW2

Job DescriptionMEDICAL DIRECTOR - REMOTE ARC Group has an immediate opportunity for a Medical Director! This position is 100% remote working eastern time zone business hours. This is a direct hire FTE position and a fantastic opportunity to join a well-respected organization and have a positive impact on the lives of millions of people. At ARC Group, we are committed to fostering a diverse and inclusive workplace where everyone feels valued and respected. We believe that diverse perspectives lead to better innovation and problem-solving. As an organization, we embrace diversity in all its forms and encourage individuals from underrepresented groups to apply. 100% REMOTE! Candidates must currently have PERMANENT US work authorization. Sorry, but we are not considering any candidates from outside companies for this position (no C2C, 3rd party / brokering). SUMMARY STATEMENT The Medicare Contractor Medical Director (CMD) provides medical leadership and decision making for an organization that serves as a Medicare Administrative Contractor (MAC). This role serves as a liaison between the Centers for Medicare and Medicaid Services (CMS) and stakeholders. CMDs play a vital role in developing Local Coverage Determinations (LCDs) and ensuring compliance with Medicare policies, reviewing medical claims, and promoting evidence-based healthcare. ESSENTIAL DUTIES & RESPONSIBILITIES Clinical Expertise and Consultation 30% Provide leadership in clinical program outreach to the practitioner/provider/supplier/beneficiary community. Provide direction and assistance to clinical staff in conducting provider education, as well as assist in the development of clinical guidelines as needed. Keep clinical knowledge up to date and abreast of medical practice and technology changes. Serve as a subject matter expert in medical and clinical areas relevant to the Medicare program. Provide clinical consultation to internal teams (e.g., medical review staff, appeals teams) and external stakeholders. Provide the clinical expertise, scientific literature analysis, claims data analytics to effectively focus medical polical policy and reviews on identified problem areas. Collaboration and Leadership 30% Collaborate with CMS and other Medicare Contractors (e.g., A/B or DME MACs and others) to develop and update medical policies and articles based on clinical evidence and regulatory requirements. Work with multidisciplinary teams within the MAC to improve processes and ensure compliance with CMS directives. Liaise with CMS staff, medical societies, and other stakeholders to align goals and address emerging issues. Represent the MAC at CMS meetings and industry conferences. Strengthen the quality improvement procedures with emphasis on decision consistency and clinical education of clinical staff through various mechanisms including but not limited to overseeing Inter-Reviewer Reliability (IRR) reviews. Program Integrity 20% Support program integrity initiatives, including identifying trends in inappropriate billing practices or noncompliance. Ensure the proper application of Medicare regulations, national and local coverage determinations (NCDs and LCDs), and clinical guidelines. Participate in all phases of LCD development by leading the Local Coverage Determination (LCD) process to include development, revision, retirement, education, and decision making. Collaborate with investigative teams and law enforcement when required. Medical Review (MR) and Appeals 10% Oversee medical review activities to ensure appropriate and consistent decisions on claim determinations including pre- and post-payment determinations. Provide leadership in developing and implementing MR Quality Assurance Programs. Provide leadership in effectively focusing MR and developing internal MR guidelines. Review complex or high-level appeals and provide guidance on the application of Medicare policies. Provide support to the claim appeal process including assistance in the development of position papers and participation in the administrative process when needed such as Administrative Law Judge (ALJ) hearings. Provider Education and Communication 10% Provide leadership in the provider community (including interacting with hospital/specialty associations). Educate providers, individually or as a group, regarding identified problems or medical policy. Maintain Professional and Organization Relationships Performs other duties as the supervisor may, from time to time, deem necessary. Travel within and outside the assignedjurisdictions, as needed. Expected to be no more than 3-4 weeks/year but could vary based on business needs. REQUIRED QUALIFICATIONS MD or DO degree from accredited Medical School Minimum of three years clinical practice experience as an attending physician Extensive knowledge of the Medicare program, particularly the coverage and payment rules Work experience in the health insurance industry, a utilization review firm, or another health care claims processing organization in a role that involved developing coverage or medical necessity policies and guidelines. Knowledge, skill, and experience to evaluate clinical evidence, and to develop evidence-based medical necessity standards within the Medicare fee-for-service benefit structure Ability to develop strategies and processes to ensure evidence-based decision-making for policy in the Medicare population Basic understanding of medical coding conventions Ability to effectively communicate, collaborate with, and provide education on health care policy issues to both internal team members and external entities Ability to work collaboratively with internal staff to evaluate aberrancies, determine appropriate billing, coding, pricing, and utilization of services Proficiency with effective public speaking and ability educate providers Ability to work collaboratively with clinical and non-clinical team members Ability and desire to educate team members and external entities (i.e., CMS, providers, other federal agencies, law enforcement, etc.) Computer literacy, including proficiency using word processing, spreadsheets, presentation, and virtual meeting applications Ability to complete independent or computer-based training and education Certifications, Licenses, Registration: Current, active, valid, unrestricted license to practice medicine in at least one state or territory within the United States, never suspended or revoked in any state or territory of the United States Eligible for licensure within jurisdiction of enterpriseoperations Board Certified Doctor of Medicine or a Doctor of Osteopathy in a specialty recognized by the American Board of Medical Specialties for at least three years PREFERRED QUALIFICATIONS Experienced Physical Medicine and Rehabilitation (PM&R), Oncology, Radiology, Ophthalmology or Infectious Diseases professionals with five years of clinical practice MBA, MHA, MS in Management, or formal accredited coursework in medical systems management Demonstrated successful working experience in organized medicine group(s) (e.g., AMA, specialty society, state health department) as a committee chairperson or other leadership Medical Director experience in Medicare-related or commercial healthcare organization Coding and billing experience utilizing HCPCs, CPT, and ICD-10 codes Experience using GRADE methodology for literature analysis and performing systematic reviews Experience working with physician groups, beneficiary organizations, and/or congressional offices Would you like to know more about our new opportunity? For immediate consideration, please send your resume directly to John Burke at ******************** or apply online while viewing all of our open positions at ******************* ARC Group is a Forbes-ranked a top 20 recruiting and executive search firm working with clients nationwide to recruit the highest quality technical resources. We have achieved this by understanding both our candidate's and client's needs and goals and serving both with integrity and a shared desire to succeed. At ARC Group, we are committed to providing equal employment opportunities and fostering an inclusive work environment. We encourage applications from all qualified individuals regardless of race, ethnicity, religion, gender identity, sexual orientation, age, disability, or any other protected status. If you require accommodations during the recruitment process, please let us know. Position is offered with no fee to candidate.

About the Company Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary The study physician is a responsible member of the clinical team providing medical expertise and medical oversight for the entire clinical trial, from initial study design through final study close-out. The medical monitor provides active medical contribution to a cross-functional clinical team for each study assigned in early development. The medical monitor is responsible for the medical monitoring, safety activities, assessment and understanding of drug induced safety findings in light of patient safety for each assigned trial. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements. Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure) Lead sponsor study process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets. Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner. Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors. Vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation. Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines Oversees and support Clinical Site Manager(s)/CRAs in the conduct of the trials Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team Review and approve vendor invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner. Collaboration with the Director of Quality and Compliance review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements. Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures. Accountable for developing and managing the Clinical Operations budget. Review draft protocol and coordinate operations in order to meet protocol requirements. Oversees EDC/CTM entries and provide appropriately QC'd study raw data to Medical Writing team for report completion. Perform quality control of clinical reports by utilizing protocol and procedural deviations reports, sample inventory, and medical writers. Confirm study medication is received and dispensed for assigned projects in a timely manner. Coordinate study monitor visits, including file review and follow-up of findings/concerns. Other projects or responsibilities as may be required. Qualifications: Experience in designing clinical trial plans, organizing clinical trials, and writing summary reports independently. Knowledge about research administration, experience with investigator initiated trials. Substantial knowledge and understanding of federal regulations affecting clinical trials and medical research is preferred. Knowledge of and experience in experimental design, and basic understanding of statistics and statistical methods is required. In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. Good therapeutic and protocol knowledge. Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods. Strong communication and interpersonal skills. Minimum Qualifications - Education and Experience Trained and certified as MD (or equivalent), preferably a minimum of 3 years of experience in medical monitoring of clinical trial Equal Opportunity Employer Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. BioMarin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring BioMarin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring. Summary Description: Fully remote role - US based candidates The Medical Director has a key scientific and analytical leadership role in the development of CLS core deliverables across study planning, design and execution, results analysis and regulatory filings. Key focus areas include: acting as a study Medical Monitor and providing the scientific input into the creation and review of all CLS study deliverables and monitoring subject eligibility, study data and contributing critically to the scientific interpretation and integration of clinical study results.The Medical Director will also contribute to the scientific strategy and plan as outlined in the Clinical Development Plan (CDP). The Medical Director is also responsible for providing medical input into the creation and review of all CLS study deliverables to support clinical decision making, problem solving, and safety surveillance, as well as collaboration with external physician stakeholders. Key Responsibilities: Scientific Leadership Support the definition of the core clinical and scientific strategy that serves as the basis for the CDP and provide CLS expertise in the design and execution of clinical studies under the purview of the CDP Participate (as assigned) in the development of CLS-assigned sections of regulatory filings and in drafting regulatory responses in collaboration with Medical Writing Establish relationships with investigators and KOLs as appropriate in support of the CDP Stay up to date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication Attend and contribute to relevant scientific conferences, seminars or presentations Clinical Study Planning and Monitoring Act as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk Initiate and provide the medical and scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions and other key study deliverables Provide clinical input to statistical analysis plan to ensure alignment with Regulatory and business interests Facilitate the review and approval of all study related CLS deliverables and content Act as study scientific subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues Provide leadership to sites by developing or participating in training, answering investigator/site questions about the protocol Respond to site and Health Authority questions about the protocol Conduct periodic review of protocol deviations in collaboration with Clinical Operations Study Lead or designee (per protocol specific Protocol Deviation Plan) Attend and present at Investigator Meetings, as needed Conduct data review, assessment and interpretation of clinical data to ensure that the data are correct and presented with the appropriate interpretation including thorough review of SAEs and other important AEs (per the study specific Medical Monitoring Plan) Review and analyze SAEs, safety and efficacy trends on an ongoing basis Work closely with the Pharmacovigilance representatives providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports and preparation of labels Participate in and provide scientific advice, as appropriate, during key Database Lock (DBL) activities (final listing review, review of blinded tables, listings and figures (TLFs), etc.) and actively participate in all data snapshots taken (not limited to final DBL) Collaborate with Biometrics to identify key issues, prepare content and facilitate discussions at study Data Review Board (internal) or Data Monitoring Committee (DMC) Lead the selection of and interactions with independent Data Monitoring Committees (DMC) The Medical Director will also act as the medical subject matter expert for review of clinical and safety data to ensure data are correct and presented with the appropriate medical interpretation and for discussing safety concerns with sites Governance and Communication Provide timely and high-quality functional deliverables and contributions to Study Execution Team (SET) Act as primary point of contact between SET and BCLS to ensure appropriate dissemination of information and communication (including functional managers and other relevant individuals) Provide agenda topics to be discussed during SET meetings Act as the medical and scientific subject matter expert (SME) to the SET with the ability to make decisions and recommendations on behalf of BCLS Proactively identify and communicate potential risks and mitigations relevant to the BCLS deliverables Contribute to the development and maintenance of study- specific plans; manage the development of study-specific plans that are the responsibility of BCLS Collaborate with BCLS Therapeutic Area Lead, CDTL and CSL on all study related decisions, as appropriate Escalate issues affecting BCLS function deliverable quality, timelines, resources or budget, as appropriate Competencies The Medical Director is expected to exhibit mastery-level understanding of multiple technical competencies, including scientific knowledge, data analysis, and scientific writing. S/he should also have advanced-level competence in several areas, including strategic thinking and problem solving. The Medical Director should: Identify scientific and medical knowledge gaps in therapeutic area and target populations to drive research and publication strategies Assess the clinical and medical impact of clinical and external research findings and data on overall therapeutic area and clinical development strategies Conduct comprehensive document evaluations including evaluation of statistical presentations, research methods, quality and completeness of content Identify internal and external best practices, trends, developments or alternative approaches that can be leveraged for strategy development Demonstrate ability to look beyond the obvious toward innovative approaches, avoiding biases and historical crutches The Medical Director will also demonstrate mastery of relevant clinical and therapeutic area knowledge to support clinical decision making, problem solving, safety surveillance, and as well as collaboration with external physician stakeholders. Education and Experience: MD, MD/PhD (or equivalent) Advanced degree in life or health sciences (e.g. PhD/PharmD/RN) 5 or more years of relevant experience in Clinical Development, with experience in genetic diseases, specialty care, and/or rare diseases desired; Clinical experience preferred Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.