Executive Director, Asset Development Team Leader
MSD Malaysia, Rahway, NJ, United States
**Job Description**The Executive Director has the primary responsibility for strategy, oversight, and delivery of end-to-end activities involving new or marketed drug(s) for oncology indications. The Executive Director leads the team responsible for the cross-functional delivery of critical milestones in an oncology asset’s lifecycle, spanning discovery through reimbursement, integrating the scientific, commercial, and manufacturing aspects critical to delivering clinically beneficial medicines to the right patients. The key to success is bearing the primary responsibility for developing, aligning, executing, and communicating the overall asset strategy.Specifically, the Executive Director may be responsible for:* Creation, alignment, execution, and adaptation of the asset strategy cross-functionally* Lead the asset development team to maximize the asset’s potential* Identifying registrational opportunities for pre-clinical and early clinical candidates which have potential to become medicines* Evaluating pre-clinical and translational work for the purpose of strategizing early clinical development plan and Investigational New Drug applications in context of potential registration* Working with relevant clinical teams to develop clinical development strategies for investigational or marketed assets that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations* Prioritizing clinical trials (design, operational plans, settings) based on these clinical development strategies for what is optimal for the asset in the context of internal and external factors* Support asset specific biomarker strategy and diagnostic readiness* Support asset specific safety management such as safety governance meetings, dose adjustments, supportive care optimization* Leading development and communication of the messaging around the asset and the asset strategy* Lead interactions with governance to secure alignment and support for asset development* 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 Executive Director may manage other Directors and/or Senior Directors on the asset development team* Mentoring and career development for direct reports (when applicable) will be a key function of the role.To accomplish these goals, the Executive Director may:* Work across teams and functions internally and/or externally (i.e. via collaborations)* Manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions* Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.**Education:*** M.D., or MD/PhD with experience in oncology* Board certified or board eligible in hematology, 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 5 years of industry experience in drug development in a relevant therapeutic area* Minimum of 5 years of clinical experience* Has designed, executed, and reported out phase 3 or registrational studies; has supported or led submission activities for labels, supported in post approval launch readiness such as publication planning, guideline submission, HTA negotiations.* Experience navigating a matrixed structure including shepherding studies/concepts through internal governance boards* Expertise as clinical lead for interactions with regulatory agencies. Experience preferred for the following: dose justification; phase 3 design; BLA/sBLA, global submissions and diagnostic use* Experience and understanding of asset and org needs for commercialization and reimbursement of approved medicines* Understanding the impact of drug manufacturing parameters on drug development execution* Management of external Key Opinion Leaders in Clinical Development and Medical Affairs activities* 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* Experience with multiple modalities of therapies (biologics, small molecules, etc.)**Required Skills:**Asset Development, Business Mindset, Clinical Development, Clinical Research, Clinical Trials, Consultative Approach, Drug Development, Hematology, Innovation, Leadership, Medical Research, Oncology, Results-Oriented, Safety Management, Scientific Consulting, Strategic Leadership**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**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
if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, Monday - 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.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The salary range for this role is$310,900.00 - $489,400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.
Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick #J-18808-Ljbffr
if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, Monday - 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.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The salary range for this role is$310,900.00 - $489,400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.
Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick #J-18808-Ljbffr