Merck Sharp & Dohme
Associate Vice President, Global Clinical Development, Oncology Asset Team
Merck Sharp & Dohme, North Wales, Pennsylvania, United States,
Job Description
The Associate Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs for oncology indications. The Associate Vice President will manage and oversee the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.
Specifically, the Associate Vice President may be responsible for:
Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
Developing clinical development strategies for investigational or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
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 vaccines
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
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds; and support of business development assessments of external opportunities.
The Associate Vice President will be a Section Head with oversight of several Asset Development Teams (ADTs). In this capacity, the AVP will have managerial responsibilities of ADT Leaders or Team Members that could include Executive Director, Senior Director, or Director level personnel responsible for oncology clinical development programs or projects.
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility.
The Associate Vice President is responsible for maintaining a strong scientific fund of knowledge by:
Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies
Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.
To accomplish these goals, the Associate Vice President may:
Oversee authoring of detailed development documents, presentations, budgets, and position papers for internal and external audiences
Manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions
Facilitating 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.
Education
M.D or M.D./Ph.D.
Board certified or board eligible in medical oncology, radiation oncology, surgical oncology or related disciplines preferred; candidates with an equivalent combination of medical training and experience will be considered.
Required Experience and Skills:
Minimum of 10 years of industry experience in drug development or biomedical research experience in academia or an equivalent combination of academic and industry experience.
Minimum of 3 years of clinical medicine experience
Demonstrated record of scientific scholarship and achievement
Prior experience leading an Asset Development Team, Product Development Team or Early Development Team is highly desirable.
Understanding of full E2E drug development process and ideally candidate would have in-depth experience in early and/or late development.
Has demonstrated success in running multiple studies and protocols
Knowledge and ability to originate new program ideas and recommends expansion or curtailment of clinical trials on the basis of results and/or scientific information, including business development and in-licensing opportunities.
Good evidence of an ability to devise and implement strategic initiatives across diverse functional groups and global pharma teams
Demonstrated experience in the design, implementation, and analysis of clinical trials
Strong interpersonal skills, as well as the ability to function in a team environment are essential
High level of verbal and written communication, including presentation skills.
Strong learning agility and growth mindset
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range: $326,300.00 - $513,600.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/7/2024
Requisition ID:
R311601
#J-18808-Ljbffr
The Associate Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs for oncology indications. The Associate Vice President will manage and oversee the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.
Specifically, the Associate Vice President may be responsible for:
Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
Developing clinical development strategies for investigational or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
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 vaccines
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
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds; and support of business development assessments of external opportunities.
The Associate Vice President will be a Section Head with oversight of several Asset Development Teams (ADTs). In this capacity, the AVP will have managerial responsibilities of ADT Leaders or Team Members that could include Executive Director, Senior Director, or Director level personnel responsible for oncology clinical development programs or projects.
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility.
The Associate Vice President is responsible for maintaining a strong scientific fund of knowledge by:
Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies
Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.
To accomplish these goals, the Associate Vice President may:
Oversee authoring of detailed development documents, presentations, budgets, and position papers for internal and external audiences
Manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions
Facilitating 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.
Education
M.D or M.D./Ph.D.
Board certified or board eligible in medical oncology, radiation oncology, surgical oncology or related disciplines preferred; candidates with an equivalent combination of medical training and experience will be considered.
Required Experience and Skills:
Minimum of 10 years of industry experience in drug development or biomedical research experience in academia or an equivalent combination of academic and industry experience.
Minimum of 3 years of clinical medicine experience
Demonstrated record of scientific scholarship and achievement
Prior experience leading an Asset Development Team, Product Development Team or Early Development Team is highly desirable.
Understanding of full E2E drug development process and ideally candidate would have in-depth experience in early and/or late development.
Has demonstrated success in running multiple studies and protocols
Knowledge and ability to originate new program ideas and recommends expansion or curtailment of clinical trials on the basis of results and/or scientific information, including business development and in-licensing opportunities.
Good evidence of an ability to devise and implement strategic initiatives across diverse functional groups and global pharma teams
Demonstrated experience in the design, implementation, and analysis of clinical trials
Strong interpersonal skills, as well as the ability to function in a team environment are essential
High level of verbal and written communication, including presentation skills.
Strong learning agility and growth mindset
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range: $326,300.00 - $513,600.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/7/2024
Requisition ID:
R311601
#J-18808-Ljbffr