Executive Director, Oncology R&D, Global Clinical Lead

3 weeks ago

Atlanta, United States Daiichi Sankyo, Inc. Full time

Join a Legacy of Innovation 110 Years and Counting
 

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.   

Job Summary:

Oversees multiple programs, alliances, large trials, such as global clinical development program for multiple product candidates with one or more indications or a single large program with multiple Ph II/III studies: Reviews regulatory documents from cross functional, holistic perspective. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.

Responsibilities:

Clinical Monitoring Planning:

  • Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL).

Clinical Surveillance:

  • Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects.

Study Strategy:

  • Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions.

Study Planning and Execution:

  • Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.

Study Outputs:

  • For large studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions.

External Collaboration:

  • Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level

People Management:

  • Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area.
  • Additional non-study related activities: Routine senior management interactions; Influential relationship with top KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late-stage compounds; Committee member, in-licensing and acquisitions.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.


Education:

  • MD with relevant clinical experience required
  • Postgraduate training in TA or related specialty required Experience Qualifications
  • 7 or More Years experience required
  • 4 or More Years managing Clinical Development group required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

  • Executive Director, Oncology R&D, Global Clinical Lead

    4 weeks ago

    Atlanta, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a...

  • Executive Director, Oncology R&D, Global Clinical Lead

    3 weeks ago

    Atlanta, GA, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a...

  • Director, Business Systems

    3 weeks ago

    Atlanta, GA, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...

  • Director Oncology R&D

    4 weeks ago

    Atlanta, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a...

  • Oncology Medical Director- Commercial National Division

    2 days ago

    Atlanta, United States American Society of Clinical Oncology Full time

    Oncology Medical Director- Commercial National Division Location: This position will work a hybrid model (remote and office). The ideal candidate must live within 50 miles of one of our Elevance Health PulsePoint locations. The Oncology Medical Director will be supporting our clients in operations with utilization and case management reviews. In addition,...

  • Director Oncology R&D

    4 weeks ago

    Atlanta, United States Daiichi Sankyo, Inc. Full time

    p>Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a...

  • Business Systems Director with Oncology Focus

    7 days ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    About Daiichi Sankyo, Inc.Daiichi Sankyo Group is a leading pharmaceutical company dedicated to creating innovative therapies to improve patient outcomes and address unmet medical needs globally.As a Global Pharma Innovator with Competitive Advantage in Oncology, Daiichi Sankyo focuses on developing novel treatments for oncology, rare diseases, and immune...

  • Director Oncology R&D

    1 month ago

    Atlanta, GA, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a...

  • Director Oncology R&D

    2 weeks ago

    Atlanta, GA, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a...

  • R&D Tax Credit Specialist

    4 days ago

    Atlanta, Georgia, United States McGuire Sponsel Full time

    Job DescriptionWe are seeking a highly skilled R&D Tax Credit Specialist to join our team at McGuire Sponsel.Salary:$65,000 - $85,000 per year, depending on experience.Company OverviewMcGuire Sponsel is a national specialty tax consulting firm that has experienced tremendous growth while serving leading accounting firms and businesses across the country.Job...

  • Executive Director

    1 week ago

    Atlanta, Georgia, United States NCR Full time

    Are you a seasoned HR professional seeking a challenging role that requires strategic thinking and exceptional leadership skills? We have an exciting opportunity for an Executive Director - Global Labor Relations to join our team at NCR VOYIX Corporation in Atlanta, Georgia.About UsNCR VOYIX is a leading global provider of digital commerce solutions for the...

  • Executive Director

    1 week ago

    Atlanta, United States NCR Full time

    About NCRVOYIX NCR VOYIX Corporation (NYSE: VYX) is a leading global provider of digital commerce solutions for the retail, restaurant and banking industries. NCR VOYIX is headquartered in Atlanta, Georgia, with approximately 16,000 employees in 35 countries across the globe. For nearly 140 years, we have been the global leader in consumer transaction...

  • R&D Credits Tax Manager

    6 months ago

    Atlanta, United States Grant Thornton Full time

    As the Tax Manager in our Corporate Tax Solutions, Research & Development Tax Credit practice you’ll navigate R&D tax credit complexity and provide insightful, practical tax advice for your clients– all with the resources, environment and support to help you excel. You’ll collaborate with leadership and supervise R&D projects, research tax issues,...

  • Senior Director of Global Operations

    1 week ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    About UsDaiichi Sankyo Group, a global pharmaceutical innovator with a rich legacy of over 125 years, is dedicated to creating innovative therapies to improve healthcare standards worldwide. Our team of 18,000 employees across 20 countries strives for excellence in oncology and other research areas centered around rare diseases and immune disorders.Career...

  • Medical Director

    7 days ago

    Atlanta, Georgia, United States Medicorp, Inc Full time

    About the Opportunity">Medicorp, Inc is seeking a highly skilled Medical Director to lead our state-of-the-art Oncology Clinic in Georgia.">About the Clinic">Our clinic features eighteen infusion stations, laboratory services, and an outpatient pharmacy on site, providing patients with comprehensive care under one roof.">We offer a weekly Multidisciplinary...

  • R&D Tax Senior Associate

    2 days ago

    Atlanta, GA, United States Frazier & Deeter, L.L.C. Full time

    Join Frazier & Deeter and be a part of a rapidly growing Top 50 accounting & advisory firm that has been repeatedly named a Best Firm to Work For, a Best Firm for Women and a Pacesetter firm among U.S. accounting firms. With offices in Atlanta , Alpharetta , Charlotte , Las Vegas , London , Nashville , and Tampa , there is a spot for you! We serve clients of...

  • Executive Director Global Talent, Learning and Employee Experience

    1 week ago

    Atlanta, United States NCR Full time

    Key Areas of Responsibility. The Executive Director Global Talent, Learning and Employee Experience will work closely with leaders in the organization to implement the NCR Voyix Talent, Learning, and Employee Experience Strategy. Key responsibiliti Director, Talent, Employee, Executive, Leadership, Experience, Technology, Business Services

  • Director data architecture design

    5 days ago

    Atlanta, United States Global Payments Full time

    Full job descriptionEvery day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. Our worldwide team helps over 3 million companies, more than 1,300 financial institutions and over 600 million cardholders grow with confidence and...

  • Director, Global Trade

    3 days ago

    Atlanta, GA, United States Mueller Water Products Full time

    Drives the ongoing strategic development, leadership, and execution of Mueller’s trade compliance programs and processes. Leads and sets priorities for Mueller’s global trade compliance by shaping and building the trade compliance team and its capabilities. Advises all levels of the organization, both domestic and international, to drive value for the...

  • Associate Director, Clinical Operations

    4 weeks ago

    Atlanta, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...