Director, Medical Operations

Location
Tarrytown, NY, United States
Posted
Sep 04, 2019
Ref
15757BR
Required Education
Masters Degree/MBA
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Director, Medical Operations will oversee the various Investigator-Initiated Studies Programs, Collaboration Studies, Registries, Phase 4 and Compassionate Use studies led by Medical Affairs, including management of direct reports, maintaining appropriate structure and procedures to support growth, and ensuring compliance. Additionally, the incumbent will ensure timely deliverables and financial management for Med Ops TA area supported.

Job Duties:
  • Support of Commercialized Products, including non-filing post-marketing research activities, timelines, and milestone deliverables, budgets, forecasting, disclosures, and compliance.
  • Support of Late Stage Molecules, and launch readiness activities
  • Support of Early Phases molecules, post-IND filing, ensure pre-clinical and non-drug studies are reviewed in line with brand and corporate strategy, and ensuring no conflicts with ongoing development plans or pre-clinical modeling activities.
  • Alliance Management: Ensuring optimal alignment with both Alliance and internal stakeholders for both processes and strategy in support of multiple products or a TA. Responsible for driving activities forward while communicating potential risks and solutions transparently.
  • Contribute to life cycle management planning, including transition plans form OLE to EAP, and to bridging programs, and development of Registry/Ph4 plans
  • Ensure IIS programs are led compliantly, with cross-functional reviews and inputs completed, and senior input as needed prior to executing.
  • Budget tracking, planning, reporting: Oversee all budgeting aspects in support of multiple products or a TA, including: annual planning, initial projections for upcoming activities/programs, drug related costs, reforecasts, actuals and accrual information. Oversees budget reporting for the following: program planning, corporate audit, sunshine act, and commercial finance.
  • Drug/material planning, shipping, tracking, expiry, temp excursions, quarantines: Oversee appropriate drug/material planning in support of multiple products or a TA, including: timing of drug and labeling campaigns, expiry events and potential impact, and ensuring compliance for shipments, temp excursions, and quarantines.
  • Program management: budgets, timelines, publications, risk management, compliance: Oversee all aspects of program planning in support of multiple products or a TA, including: life cycle management planning, allocation and movement of program budgets, timelines and program deliverables, risk strategy/mitigation planning, and ensuring annual review of Areas of Interest in alignment with corporate strategy. Ensures compliant, efficient, and effective management and execution of each program's deliverables in line with brands and corporate strategy
  • Provide strategic leadership as needed towards business development agreements and alliance partnerships/out-licensing, sBLA filings, and filing transfers, assay development and new product development.
  • Compliance: IIS Processes, FMV, CompUse, Safety, Regulatory, Training. Adheres to and ensures team adherence to all applicable SOPs, working guidance, workflows, required reporting, maintaining compliant support of programs. Create/update relevant SOPs, working practices, forms and tracking documents as needed, ensuring audit readiness
  • Recruit and develop direct reports ensuring growth minded goals, and development plans.

Requirements:
  • Minimum of Master's Degree or equivalent work experience.
  • 16+ years of "progressive" industry/relevant professional experience. Biopharma is required
  • 11+ years active work experience in area of clinical research and/or regulatory and//or field-based function in pharmaceutical and/or biotech company(s) and experience or courses pertaining to clinical research and/or MA functional areas
  • Stellar record of being successful in fast-paced, dynamic environment, self-motivated, works with limited supervision, once acclimated to role and enjoys working with different stakeholders
  • Foresight of areas for growth, improvement, refinement, and potential risks
  • Ability to communicate and effectively influence sr. management both internally and externally
  • Critical thinking skills with unique problem-solving abilities for new and novel obstacles
  • Ability to redirect and create solutions for new regulations or anticipation of updated regulations
  • Ability to lead effectively lead, motivate, and ensure compliance across the department
  • Ideally, have a science background with active experience in aforementioned areas, ideally in the therapeutic areas of (specify TA area here) and/or antibody research.
  • Must have track record of working well in a dynamic environment, must be self-motivated, able to work with a limited amount of supervision after the initial on-boarding period and enjoy working with different stakeholders (clinical, pre-clinical, commercial, external customers).


This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.