Executive Director, Clinical Development (MD)

Gilead Sciences•Parsippany, NJ

2d•$317,305 - $451,660•Onsite

About The Position

We are seeking a highly motivated leader to join us as Executive Director, Clinical Development (MD) in the multiple myeloma disease area. This role will play a key role in development and oversight of cell therapy programs, collaboration with external partners, and support evaluation opportunities for expanding the clinical development program. You will lead a portfolio of clinical trial programs in cell therapy clinical development.

Requirements

MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
Board certification in hematology and/or medical oncology is preferred, including familiarity with clinical oncology.
Experience in the biopharma industry is strongly preferred; submissions and conducting phase 2-3 late development studies.
Experience in multiple myeloma disease area, and cellular therapy therapeutic area is strongly preferred.
Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight.
Multiple years’ line management (direct reports) experience is preferred.
Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
Proven track record of achieving or exceeding large-scale, complex short and long-range strategies in life sciences, healthcare, consulting, or academia.
Expert-level of knowledge of drug development, as evidenced by proven track record in setting short and long-range drug development strategies and plans.
Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
Excellent communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
When needed, ability to travel.

Responsibilities

Accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across the portfolio.
Lead and direct the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan.
Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations.
Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.
Routinely represents the assigned products in cross-functional steering and/or governance committees.
Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products.
Leads both written and oral communications with health authorities.
Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications.
May assist in the clinical evaluation of business development opportunities.
Develops thought leader and other external relationships that can guide short and long-range clinical development strategies and direction for the disease or therapeutic area overall.
Adheres to regulatory requirements inclusive of GCP and ICH guidelines of study conduct, and industry practices and standards including internal SOPs.
Typically manages a team of direct reports.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.