Sr. Director, Medical Affairs Registries Job

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Date: Jun 19, 2014 Location: Summit, New Jersey, United States Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture Summary/Scope: Provides strategic oversight and operational leadership for US Hematology Oncology Medical Affairs (USMA) registry program with a focus on the assessment and oversight of the patient registries and the development and maintenance of accurate program operational plans including timelines and budgets. Represents USMA on assigned cross functional teams, contributes to program(s) strategy development, identifies and supports resolution of program issues, and helps facilitate alignment within Medical Affairs and with other functions within Celgene as well as with external partners. Responsible for management and development of direct reports. Responsibilities will include, but are not limited to, the following: • Designs and conducts patient registry studies to support Medical Team goals. • Provides oversight of internal and external teams (e.g., CRO) to provide guidance and ensure appropriate study protocol execution, project management and analyses. • Represents Registries in Medical Teams relevant to assigned molecule(s)/indication(s) and is responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient medical plan execution. • Partners closely with and seeks input from Medical Team Leads (Medical Directors) and Steering Committee (SC) members to ensure clear direction and alignment internally and externally of registry study objectives, analyses and publications. • Scientific Lead of the relevant registry Study Management Team and partners closely with SMTL on internal and external Clinical Operations’ activities. • Develops high-quality, comprehensive protocols containing clearly defined patient populations, study objectives, and study design that can be readily and correctly implemented. • Delivers high-quality, key deliverables to meet Medical Team medical objectives by promised time. • Represents Registries for the assigned molecule(s)/indication(s) to other internal and external customers and stakeholders. • Stays abreast of internal and external developments, trends and other dynamics relevant to the conduct of registry studies in the United States and abroad to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s). • Maintains the highest standards and levels of scientific/clinical and epidemiologic knowledge in the specific therapeutic and disease area(s) of assignment. • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), cooperative groups, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc. • Plays a lead role in providing analytical input into the relevant disease/therapeutic area scientific strategy. • Provides leadership guidance to other teams and groups in development of patient registries (including strategies for patient registry recruitment). • As needed, advises others in the identification and selection of appropriate external investigators and sites. • Plays a lead role in, or otherwise advises others regarding, the development of study analytics and data management plans for relevant studies. • May play the lead role, or delegate such to others, representing the company in key investigator or other external presentations, meetings and other communications. • Accountable to ensure investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study. • Collaborates with others and/or otherwise guides others in measurement and monitoring of study progress against objectives and plans, including any variances. Includes proactively guiding other team members on identifying, communicating and addressing any issues, challenges and potential strategies to resolve such. • Reviews and approves various interim study analyses and reporting prior to further dissemination. • Oversees registry study, database and study reporting completion. Approves final study reporting prior to further dissemination. • Accountable to ensure correct medical/scientific data interpretation for interim and final study reporting. • Drives ongoing data generation. Plays a lead role within the assigned therapeutic area(s) to identify significant opportunities for unmet medical needs. • Accountable to ensure that registry plans, objectives, and deliverables are consistently accomplished on-time and on-target. . Stays current on pharmacoepidemiologic and statistical methods and partners closely with the biostatistician and statistical programmers to ensure the highest quality analyses. . Interact/liase with other departments as well as cross-functional teams (i.e. Legal, Disease Teams, Global Medical Affairs Effectiveness, Outsourcing, etc.), including: Represent USMA on assigned Clinical and/or Medical Affairs Teams, identify and recommend solutions to problems and/or issues with personnel and/or processes across departments, provide specific project / program support as appropriate USMA Initiative Guidance: • Participate in vendor selection, review and oversight process • Provide guidance and development to USMA team members globally in the assigned areas Budget & Resource Planning: • Drive the early planning of USMA program timelines and budgets through close collaboration with other functions (e.g. USMA Disease Leads, Finance, and other relevant functions) • Collaborate closely with USMA leadership to ensure that timelines and budgets are appropriately presented to oversight committees. • Support identification and resolution of issues related to timelines and budgets • Lead regular (e.g. quarterly) program review meetings with Executive Director Disease Leads and ensure that anticipated deviations are flagged. Talent Development/Management • Provide oversight to direct reports to ensure program management in accordance with functional guidelines/processes, applicable regulations/guidelines and SOPs/WPs to support compliance, quality, efficiency and successful completion of operational activities related to key program milestones • Build the functional expertise of the department and ensure that adequate onboarding, program-specific and role-specific training is provided • Develop, coach, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key programs and deliverables • Engage and energize employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements • Facilitate functional talent development and performance management processes to ensure that individuals are held to appropriate, consistent standards and that key leadership development and succession plans are established • Serve as resource or mentor on contracting and operational issues where appropriate • Provide guidance regarding company policies and procedures • Develop and promote strong collaborative relationships with colleagues within and outside Celgene, demonstrating teamwork and leadership skills Continuous improvement • Collaborate with colleagues within Medical Affairs and from other Departments to maximize efficiencies, share and apply best practices • Flag potential process improvement opportunities and support execution Qualifications Qualifications 10+ years of relevant experience in the Pharmaceutical Industry with a PhD or ScD...or an MD with an MPH degree in Epidemiology or Biostatistics. Skills/Knowledge Required: • Experience in pharmaceutical clinical trials– hematology/oncology therapeutic area experience strongly preferred • Knowledge of the pharmaceutical ie registry agreements, and industry trends • Excellent interpersonal, facilitation, negotiation and communication skills • Demonstrated leadership skills, prior experience managing people • Demonstrated ability to function in a highly matrixed team environment • Proven ability to multi-task • Strong oral, written, and organizational skills • Demonstrated Competencies in: - Analytical Thinking - Thoroughness - Detail Orientation • Financial forecasting and budgeting skills & resourcing skills • In depth knowledge of pharmaceutical industry guidelines/directives and industry, including solid knowledge of interfaces and interdependencies of Medical Affairs with other functions (e.g. clinical/nonclinical & pharmaceutical development, regulatory, commercial/marketing) • Have a solid understanding of the cross functional components that impact USMA initiatives and integrate appropriate input arising from internal and external team members into the program strategy • Proven problem-solving skills to prevent and overcome complex issues during USMA program implementation and execution • Ability to lead and drive program planning and delivery in collaboration with internal and external partners • Demonstrated effectiveness as mentor, coach, and leader • Demonstrated ability to build and maintain a high performance team • Extensive experience in leading contracting activities, preferably managing contract associates • Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries • Leadership of a team in meeting multiple conflicting priorities and making resource allocation recommendations (financial and people) • Experience in leading/directing change management in a dynamic environment Key Leadership Competencies: • Creates operational plans that clearly define the function’s goals, milestones, and results • Maintains focus on strategic objectives while accomplishing operational goals • Sets high performance standards, balancing a bias for action with a focus on quality • Holds self accountable, setting an example that others can follow • Makes sound decisions that align with Celgene’s USMA goals and strategy • Demonstrates financial skills relevant to the position (e.g. budgeting, working knowledge of key financial measures, etc.) • Develops and maintains effective working relationships with people across functions • Encourages and supports collaboration across teams, functions, and geographies • Ensures that conflict is handled constructively so that performance is not impacted • Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute • Cultivates networks of people across a variety of functions and locations • Promotes the sharing of information across departments and/or teams within the function • Considers influences, situations, and implications when making plans or decisions, solving problems, or developing strategies • Demonstrates understanding of the external environment and its implications for both Celgene’s and the USMA goals and strategies • Translates the USMA organizational vision and strategies into meaningful plans for the function, connecting them to the mission of the team • Provides direct reports with appropriate levels of autonomy and decision-making authority • Provides direct reports with constructive performance feedback on a regular basis • Works with direct reports to identify strengths and development needs, and to help them create effective development plans • Supports direct reports in meeting their developmental goals by giving them challenging assignments and other learning opportunities EEO Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. *LI-PB1 MON Req ID: 14001837 Primary Location: United States-New Jersey-Summit Job: Marketing and Sales Excellence Organization: Celgene Corporation Schedule: Regular Shift: Standard Employee Status: Director Job Type: Full-time Job Level: Day Job Travel: Yes, 5 % of the Time Job Posting: 2014-06-19 00:00:00.0
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