Associate Director, Publications Lead, Oncology

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OBJECTIVES/PURPOSE

As a subject matter expert on ethical standards and industry guidelines related to scientific publications best practices and the development of scientific publication strategy, the Associate Director, Publications Lead, Oncology proactively defines and drives the publication strategic plan for the assigned oncology assets based on medical strategies, transparency requirements, and data availability.

The Associate Director, Publications Lead, Oncology develops and implements strategic publications plan in coordination with relevant cross-functional teams (including members of medical affairs, clinical development, and outcomes research; global, regional, or local); leads the publications planning team; manages the development of scientific publications for external audiences, including, but not limited to, manuscripts, abstracts, posters, and oral presentations; manages vendors, freelancers, and available contractors, writers, and editors in the execution of publication tactics; and manages annual budget planning for each assigned program(s). The individual in this role will be responsible for driving the publications process and ensuring compliance with global standards, and for ensuring accuracy and scientific rigor of publications. The Associate Director, Publications Lead, Oncology will serve as the primary liaison with internal and external opinion leaders, investigators, authors, partners, and affiliates on publication activities related to the compounds/programs.

The Associate Director, Publications Lead, Oncology will have strong leadership skills required for training internal teams on good publications practices and will play an active role in providing guidance and training to Publications department colleagues on publication strategy development and tactical execution best practices. This individual will work closely with the Director, Publications Oncology to optimize department resources and evaluate trends in medical publications, and lead and/or participate in the development and review of publications SOPs and Work Practices, where appropriate, to ensure delivery of high-quality medical publications in a timely and compliant manner across programs.

ACCOUNTABILITIES

• Proactively develop, manage, and execute on global or regionally integrated strategic publication plans in coordination with cross-functional teams, ensuring alignment with product medical strategies and medical communication plans
• Have a strong understanding of prioritized disease areas, including landscape and competition
• Lead cross-functional strategic publication planning team meetings, including annual publication planning workshop for assigned programs
• Initiate communication with authors; identify all necessary data required for content development; participate in author meetings to facilitate content discussion and ensure appropriate content development process is followed
• Critically review publications including, but not limited to, manuscripts, abstracts, posters, and oral presentations, for accuracy and scientific rigor; manage and facilitate the content review process, including collating reviewer comments and having discussions with authors and reviewers
• Commitment to ethical practices in the preparation and dissemination of publications
• Ensure compliance with all applicable laws, regulations, and policies
• Interact directly with Clinical, Statistics, Regulatory Affairs, and Medical Affairs to fully understand development programs, regulatory and medical strategies, and key scientific and communication objectives for the therapeutic area and develop appropriate scientific publications
• Effectively and consistently communicate the publication strategy, tactical plan, and plan progress to internal business partners; work with vendors and internal technical support groups to evaluate and optimize publications systems for reporting metrics to meet stakeholder needs
• Manage medical writing agency, including oversight on execution of publications plans and budget, and maintenance of publications management databases such as Datavision
• Manage alliance partnerships
• Evaluate trends in medical publications and drive opportunities for enhanced publications content to increase value of publications in scientific exchange; lead and/or participate in process development and refinement, as/if needed
• Lead and/or participate in recruitment of vendors to fill resource gaps
• Provide guidance and training to Publications department colleagues on publication strategy development and tactical execution best practices
• Conduct internal company training on publication processes and guidelines
• Coordinate, plan, and manage publications budget for assigned program(s) in close collaboration with GMAO Operations team
• Provide medical and scientific review of Global Medical Affairs Oncology materials (and, if required, promotional materials) to support the medical (and promotional) review process
• As a subject matter expert for the assigned programs, contribute to the development of content for Global Medical Affairs projects, including but not limited to, NCCN compendia, training materials, global congress plan, and medical resource tools, as needed
• Serve as the Global Publications Oncology representative on relevant Global Medical Strategy Team
• Attend conferences, symposia, or other meetings, as necessary or as assigned, and act as liaison between Global Publications Oncology and external content contributors

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education, Experience, and Knowledge:

• Doctoral degree (PhD, PharmD) in a scientific discipline, with a minimum of 5 years of healthcare or related experience, inclusive of 3+ years of experience with the development and execution of medical publications, including medical writing experience, within medical affairs in the pharmaceutical or biotech industry or within a medical communications agency

• Master’s degree in a scientific discipline with a minimum of 8 years of healthcare or related experience, inclusive of 6+ years of experience with the development and execution of medical publications, including medical writing experience, within medical affairs in the pharmaceutical or biotech industry or within a medical communications agency

• Oncology experience strongly preferred
• Knowledge of the scientific publication planning processes, current standards of good publication practice ( GPP 22), pertinent external guidelines related to industry publications (ICMJE), and scientific reporting standards for studies (CONSORT)
• Strong written and verbal communication skills with demonstrated ability to manage several projects simultaneously
• Ability to work well independently and under pressure
• Strong capabilities and experience with resource allocation and vendor management
• Ability to synthesize, interpret, present, and discuss complex medical and scientific data
• Understanding of pharmaceutical clinical development and product life-cycle management, clinical trial design and execution, statistical methods and clinical trial data reporting requirements
• Experience with development of medical publication strategy and management of consultants and vendors
• Experience with publications management databases such as Datavision
• Working experience in cross-functional teams and global/local teams within the pharmaceutical or related industry

Competencies:

• Strategic Approach: Ability to identify opportunities and anticipate changes in the business landscape through an understanding and ongoing assessment of the environment
• Collaboration: Ability to cultivate a broad network of relationships throughout the organization, connecting global, regional and local organizations. Requires experience and success in working in a matrix, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results
• Engage Others: Ability to create a clear and unifying vision inspiring teams to excel
• Drive for Results: Creates functional strategies and goals that are closely aligned with company objectives and develops metrics to track and assess performance
• Creativity and Innovation: Ability to contribute to data analytics and publication planning, including ideas for sub-analyses
• Compliance and Regulatory: Excellent understanding of regulatory, compliance and legal requirements
• Technical Skills: Advanced PC skills, including Datavision, MS Project, Word, Excel, Power Point, and SharePoint

TRAVEL REQUIREMENTS:

Up to 10% domestic and international travel required

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Preference will be given to candidates with a remote location near, and availability to work during the working hours of, the corporate office in Boston, Massachusetts.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.