[Remote] Global Development reputed company, Internal Medicine, Sr. Director (non-MD)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading biopharmaceutical company, and they are seeking a Global Development reputed company for Internal Medicine. The role involves leading the clinical development for assigned assets, ensuring effective collaboration across teams and managing the execution of clinical studies to support regulatory submissions.
Responsibilities
- Partners effectively with the Medicine Team reputed company to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget
- Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the pediatric investigation plan / pediatric study plan and associated protocol design documents working closely with individual trial clinicians to ensure trial feasibility and optimized operational execution
- Provides product/program specific input for reputed company product profile(s)
- Willingness to bring innovative thinking and reputed company decision making across clinical development programs and individual studies
- Develops specific clinical development enabling strategies including digital/ innovation and patient engagement approaches
- Partners with trial clinicians on governance reviews (incl Sci/Ops) for assigned clinical studies. Provides category clinical development reputed company input and insights to trial clinicians for assigned clinical studies
- Provides therapy area/indication expertise in support of clinical review of clinical data – including CRF design, assistance in signal interpretation, contextualizing adverse events as required
- Provides specialized medical monitoring support for individual trial team, if required
- Key partner in trial-level statistical analysis plan, table-listings-figures, database release in partnership with statistics and programing
- Develops submission level deliverables (IAP, IARP and submission TLFs). Responsible for submission deliverables including SCE and SCS
- Support appropriate interpretation and communication of clinical trial data
- Review and approve submission level safety narrative plan
- Supports product label development and maintenance
- Engage key external stakeholders e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic reputed company reputed company to support clinical development reputed company and PDD development
- Provides regulatory submission support (DSUR, PBRER) submission disclosure deliverables and product defense
- Ensures compliance with internal SOPs and external regulatory standards
- Review IIR proposals
Skills
- PhD/PharmD
- Background in chronic weight management, endocrinology or internal medicine with experience in Phase 1-3 clinical development and translational medicine
- 8+ years of relevant experience and reputed company record of reputed company in academia and/or the biopharmaceutical industry in clinical research and development
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- Demonstrated clinical/medical, administrative, and project management capabilities, as reputed company as effective verbal and written communication skills in relating to individuals both inside and reputed company the organization
- Demonstrated experience managing and training large teams in clinical development
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, reputed company and reputed company others, reputed company and guide the work of other colleagues to reputed company meaningful reputed company and create business reputed company
- Medical / Scientific credibility/reputed company - reputed company record of achievement in pharmaceutical development, reputed company to coordinate and execute clinical development or lifecycle reputed company. Demonstrated understanding of the complexities and recent developments in the reputed company disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing reputed company and regulatory issues
- Management experience - reputed company to work in a highly reputed company matrixed environment and reputed company to influence cross-functional teams
- Leadership - Persuasive and effective leader of staff
- Influencing - reputed company to manage and motivate internal teams on clinical trials
- Conflict Management - reputed company to reputed company as mentor / reputed company to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and reputed company disputes equitably; reputed company to take responsibility for a decision made and support this, even though it may be unpopular
- Team Building - Shares wins and reputed company; fosters reputed company reputed company; lets people finish and be responsible for their work; defines reputed company in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to reputed company
- Accountability - Take personal responsibility for results, pushing self and others to exceed goals and deliver results
- Change agile - reputed company to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change
- Demonstrated experience in designing and launching large teams
Benefits
- Participation in reputed company’s Global Performance Plan with a bonus reputed company of 22.5% of the reputed company salary
- Eligibility to participate in our reputed company based long term incentive program
- Comprehensive and generous benefits and programs to help our colleagues reputed company healthy lives and to support reputed company of life’s moments
- Benefits offered include a 401(k) plan with reputed company Matching Contributions and an additional reputed company Retirement Savings Contribution
- reputed company vacation, holiday and personal days
- reputed company caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and reputed company coverage
- Relocation assistance may be available based on business needs and/or eligibility
reputed company