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Associate Director, Clinical Operations, Standards and Planning
Location
United States
Posted
85 days ago
Salary
$175K - $195K / year
Seniority
Senior
Job Description
Associate Director, Clinical Operations, Standards and Planning
Apogee Therapeutics
• Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team • Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation • Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s • Collaborate with Apogee Process Excellence and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness • Oversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization • Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organization • Develop, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globally • Collaborate with cross functional Clinical Study Team members to develop end-to-end clinical operations process, tools and resources • Collaborate with Clinical Study Team members and CRO to develop necessary standard practices to meet clinical trial country specific operational requirements • Lead and participate in key process improvement initiatives to ensure continuous process improvement • Lead any assigned departmental activities to support a highly functioning Clin Ops organization
Job Requirements
- Minimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations related role
- Bachelor’s degree required
- Experience in operationalizing large, global clinical trials and providing oversight of CRO’s and other vendors
- Experience driving innovation in clinical trial operations to increase efficiency and implement best practices
- Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellence
- Experience managing CROs, vendors and/or clinical trial consultants
- Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, an major Health Authority regulations
- Strong project management skills, effective matrix leadership, and the ability to deliver
Benefits
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team, in-person meetings to build relationships and problem solve
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At our company, we move fast, adapt quickly, and turn challenges into opportunities—all while keeping quality at the heart of everything we do. We believe that work should be a positive and respectful place, and that with the right mindset, anything is achievable. Our Vision: Fulfill the essential promise of pharmacy care and help people to live to their healthiest, happiest, and fullest potential. Our Mission: To be the disruptive force that drives meaningful change within pharmacy services. Summary The Clinical Programs Pharmacist plays a pivotal role in health outcomes improvement and prescription drug optimization. The goal of WellDyne Clinical Programs is to apply up-to-date and advanced clinical knowledge and data-driven strategies to enhance the quality, safety, and cost-effectiveness of medication therapy. Our programs aim to improve the management of chronic conditions through medication therapy and other interventions. The role of the Clinical Programs Pharmacist will involve patient education, monitoring, support, and collaborating with product design teams in the development of programs. Reporting directly to the Manager, Clinical Programs, this position encompasses a range of responsibilities, from medication therapy oversight to participating in pharmacy benefit development, and direct patient support in clinical programs. Essential Duties & Responsibilities - Primary responsibility is the day-to-day management of clinical programs, maintaining database and process to schedule and support patients, and deliver against program design. - Assist with clinical disease management through care plans. - Telephonic patient assessments or health coaching for chronic diseases. - Support patient and prescriber engagement for clinical program initiatives. - Assist with clinical and operational demands of other business units in the company as needed. - Educate providers on claims and benefit procedures. - Assist in the development of reports supporting the work and outcomes on behalf of patients and clients. - Proficiency in literature review and formulating comprehensive responses to drug information questions or needs. - Assist with establishing policies, procedures, and internal processes. - Conduct drug utilization reviews and interventions. - Assist in developing and operationalizing clinical programs as guided by Manager of Clinical Programs - Conduct comprehensive medication reviews and patient consultations on drug therapy. - Collaborate with other clinical program staff (eg nurses, health coaches) to help optimize population management and coordination of care through both pharmacologic and non-pharmacologic patient guidance. - Communicate with patients and providers, including outbound calls. - Perform additional duties as assigned by management. - Operate in accordance and complies with all Federal and State pharmacy rules and regulations, and company policies and procedures. Education and Experience - Doctor of Pharmacy degree obtained from an accredited college or university. - Active pharmacist license in good standing in state of practice. - Active/Clear License to practice in Florida as required by profession. - Proficiency with Microsoft Word, Excel, and Outlook required. - Two years minimum clinical experience preferred. - 2-3 years of experience in a managed care setting preferred. - Experience in providing clinical presentations and/or progress updates preferred. - Experience in formalized projects or improving clinical operational processes preferred. - Exposure to clinical and analytical problem-solving and expertise in drug information - Proficiency with Power Point and Access preferred. Knowledge, Skills, and Abilities - Time management - Excellent customer / patient service skills. - Empathy and understanding of patient needs. - Oral and written communication skills. - Professionalism. - Ability to multi-task and be detail oriented. - Ability to work efficiently without creating distraction or disruption to other employees. - Ability to relate well and communicate effectively with other employees and patients. - Ability to work well with various personalities and work as a team. - Ability to work cross functionally - Ability to work and accomplish goals with little to no supervision. - Able to conduct presentations either to internal departments or external to clients on clinical program initiatives. - Organizational skills - Must be dependable and maintain levels of confidentiality. - Knowledge of scope of clinical services allowed by your profession and law regulation professional practice. - Evaluate drug therapy appropriateness, effectiveness, safety, and adherence. - Communicate with healthcare providers and ensure continuity of care. Work Environment / Physical Demands This position is in a typical office environment which requires prolonged sitting in front of a computer. Requires hand-eye coordination and manual dexterity sufficient to operate standard office equipment including operation of standard computer and phone equipment. May have occasional high stress when dealing with customers/clients. Some travel may be required. EOE M/F/D/V – WellDyne and HealthDyne are equal opportunity employer and prohibits discrimination of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, veteran or disability status, or any other protected status under federal, state, or local law.
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