Directory, HEOR, Medical Affairs

Location
94080, South San Francisco
Posted
Jul 13, 2018
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

DIRECTOR, HEOR, MEDICAL AFFAIRS

Job Summary:

The Director, Health Economic and Outcomes Research (HEOR), Medical Affairs will design, develop, oversee and/or execute plans in support of new product launches in coordination with Clinical Development, Pipeline Marketing and Market Access. They will also be a subject matter expert (SME) in value creation, with a deep understanding of HEOR research related to specialty drugs.

Essential Duties and Responsibilities:

These may include but are not limited to:

  • Develop, execute and modify the HEOR strategy and plans to leverage and demonstrate product value, including studies on burden of illness, real-world clinical outcomes, epidemiology, quality of care and unmet need
  • Member of a cross-functional sub-team on HEOR for continuous identification of gaps and creation of health outcomes data in support of brands and indications
  • Identify and manage vendors to create and implement a HEOR strategy
  • Educate internal teams on the value and impact of HEOR and the need to continually refine product outcomes and economic positioning in pre- and post-approval settings
  • Ensure the alignment of HEOR and overall HCP and payer strategies as well as ensure alignment of tactical plans with commercial and medical strategy
  • Advise on relevant study concept documents, protocols and statistical analysis plans regarding Phase Ib/II and Phase III and post-marketing studies and ensure the appropriate HEOR considerations and PRO instruments are incorporated into the studies
  • Lead PRO data assessment and incorporation of all relevant data points from studies into any regulatory submissions and publications
  • Collaborate with the Clinical Development and the Project Teams to ensure appropriate and timely integration of all relevant outcome research into the clinical trials and regulatory submissions to maximize the US Product label and value evidence
  • Ensure that appropriate quantitative research and health economic modeling are undertaken to develop an integrated approach for maximizing brand value proposition for launch and early/sustained market access
  • Collaborate with the publications lead to develop and execute a comprehensive and compelling HEOR publication plan as a part of the product publication strategy to appropriately disseminate the value messages and evidence
  • Collaborate with Market Access to create the brand Value Messaging and Pricing Strategies
  • Set budgets and allocate resources in alignment with launch readiness plan & budget processes within GBT
  • In the post marketing setting, this position is responsible for developing and executing product life-cycle and labeling strategies in collaboration with scientific and commercial team member
  • Conduct research and ad boards using claims data, chart reviews, literature, registries, government survey data, and other resources to summarize epidemiology and disease burden and unmet needs.  These studies should produce high-quality project deliverables to agreed timelines and budget
  • Develop and update SOPs as required
  • Manage outside vendors and budget 

Qualifications:

  • Accredited MD, PhD, PharmD, MS or MPH with a minimum of 8+ years of relevant industry experience in pipeline and marketed products or areas such as public health, health services research, and health economics or health policy
  • Small company/biotech experience strongly preferred
  • Proven domestic launch experience
  • Strength in managing products in different clinical development stages
  • Solid understanding of methodological, quantitative and analytical skills including budget impact, cost-effectiveness, cost-utility analyses, prospective studies, and claims database analyses (burden and cost of disease) combined with a sound understanding of how to successfully apply health economic research principles to support the commercial enterprise
  • Proven ability to think strategically and make sound health economic and business decisions
  • Strong project management skills with oversight experience in both internal and external projects are necessary; demonstrated multitasking, time management skills and experience completing projects on budget
  • Solid understanding and experience in pharmaceutical product development and/or commercialization (may be concurrent with health economics research and strategy experience)
  • Demonstrated knowledge in HE/PRO (Health Economics/Patient Reported Outcomes), clinical trial protocol and CRF (Case Report Form) development, and a good understanding of study designs that produce clinically and economically relevant value information in both a development and post-launch period
  • Ability to understand the Value Based needs of the US payer, both commercial and government, with respect to clinical trial design
  • Solid understanding of legal and regulatory issues impacting HEOR and PRO labeling and promotional claims
  • Demonstrated understanding of the dynamics of the US health care system
  • Strong and interpersonal skills with demonstrated ability in leading multiple cross-functional teams, excellent skills in leading independently, and negotiating and managing through influence
  • Strong communication skills and previous experience in managing executive presentations related to strategy and execution
  • Ability to foster relationships, build alignment, negotiate and collaborate with internal and external stakeholders
  • Knowledge and understanding of relevant clinical and therapeutic issues in rare disease or hematology/oncology
  • Proficient in scientific literature searches, analysis, evaluation, and developing abstracts, manuscripts, conference presentations, and posters
  • Excellent written and verbal communication skills
  • Exceptional organization and project planning skills
  • Demonstrated ability to work in cross-functional teams across the organization in a dynamic environment
  • Proficient in MS Word, Excel, and PowerPoint

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity 

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.