Oncology Clinical Director, External Collaborations (Early Stage Clinical Development)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as MSD in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its legacy for over a century. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Director reports to a Senior or Executive Director in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. MSD's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure).
The Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be responsible for:
- Provide scientific and medical leadership, as needed, for strategic alliances and co-partnership opportunities
- Lead the organization in prioritization of valuable external collaborations. Recognize and capitalize on opportunities that allow adaptation of projects considering market changes
- Manage all aspects of selected opportunities, developing the strategy and detailed milestones, measures, timelines and budgets to achieve designated value inflection points.
- Identify, negotiate and maintain critical external partnerships
- Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications;
- Devising clinical development strategies for investigational or marketed Oncology drugs;
- Planning clinical trials (design, operational plans, settings) based on these clinical development strategies;
- Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs;
- Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and participating in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
In executing these duties, the Director may:
- Supervise the activities of Clinical Scientists in the execution of clinical studies;
- Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and
- Assist the Senior/Executive Director in ensuring that appropriate Corporate personnel are informed of the progress of studies of MSD's and Competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
The Director is responsible for maintaining a strong scientific fund of knowledge by:
- Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies; Identifying scientifically and operationally strong investigators who can assist in the development of MSD's investigational and marketed drugs;
- Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of MSD drugs;
- Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.
To accomplish these goals, the Director may:
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences;
- Facilitate collaborations with external researchers around the world;
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.
- Provide scientific and medical leadership for strategic alliances and Co-partnership opportunities
- Support the team in prioritizing external collaborations. Recognize and capitalize on opportunities to adapt direction in light of project successes and failures and market changes.
- Manage selected opportunities, developing strategy and detailed milestones, measures, timelines and budgets to achieve designated value inflection points.
- Identify, negotiate and maintain critical external partnerships.
- M.D or M.D./Ph.D
- Must have experience in industry or senior faculty in academia
- Minimum of 3 years of clinical medicine experience
- Minimum of 1 year of industry experience in drug development or biomedical research experience in academia
- Demonstrated record of scientific scholarship and achievement
- A proven track record in clinical medicine and background in biomedical research is essential
- Strong interpersonal skills, as well as the ability to function in a team environment are essential.
- Board Certified or Eligible in Oncology (and/or Hematology)