Director, Global Medical Affairs - Enhanze / Hylenex Medical Director

Halozyme

Education
Company Type
Workhours
Qualifications

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.  

In order to move forward, you will need to create an account.   Your password must be eight characters long, contain at least one special character, one capital letter and a number. 

We look forward to discovering your talents.

POSITION SUMMARY:

The ENHANZE/Hylenex Medical Director is responsible for being the lead Medical advisor and information provider for ENHANZE and Hylenex. The ENHANZE/Hylenex Medical Director will serve as the Medical product/subject matter expert on ENHANZE in interactions with external customers and internal, key, cross-functional stakeholders, including Alliance Management, Regulatory, Clinical Development, Research, Quality, Product Development, Business Development, CMC, Safety, and Commercial. The ENHANZE/Hylenex Medical Director will also function as Medical lead for the Hylenex Commercial and Operations Teams and participate in all relevant Medical activities, including provision of support for creation/review of developed materials, periodic safety updates, and any routine regulatory updates required for Hylenex.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

  • Participate in and provide Medical support of ENHANZE Success Team (EST) and all active partner Core Teams (current and future)
    • Attend regular/standing and ad hoc team meetings, provide input as needed, and follow-up on action items/projects as assigned
    • Participate in preparation for and execution of F2F kick-off and follow-up partner meetings, Regulatory calls, follow-up partner calls, and take on action items and questions from partners as needed
    • Lead clinical/medical presentations and discussions during partner calls and visits
    • Update/develop Medical/Clinical content of ENHANZE new partner kick-off slides
    • Provide input to all rounds of label reviews and participate in label negotiation calls with partners
    • Provide input for protocol and protocol amendment reviews
    • Review Halozyme questions received from regulatory agencies and participate in development of responses; participate in internal regulatory updates as needed
    • Review and provide input for partner responses/submissions to regulatory agencies and participate in calls to determine required follow-up
    • Review publications before submission to scientific congresses/journals
    • Review and provide input to CSRs
    • Function as direct Halozyme Medical contact for partners/respond to ad hoc partner inquiries as needed
    • Review and provide input to partner materials and resources
    • Bring sub-team recommendations to EST via issue log development and presentation for discussion/endorsement/follow-up plans for execution—convene sub-teams as needed, develop follow-up plans, and execute on approved plans
    • Provide Medical input for development and review of clinical trials/key messaging content
    • Participate in ENHANZE strategic planning, including provision of Medical support to sub-teams as assigned
    • Support critical workflow efficiency and improvement initiatives,
    • Provide Medical review of safety updates
    • Support development and roll-out of ENHANZE onboarding program
  • Provide Medical support of Business Development clinical plans/pitch decks for potential new partners and activities to evaluate, engage, and onboard new partners
    • Participate in Business Development pitch meetings and provide scientific support as needed
  • Conduct business in accordance with Halozyme Values

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

  • Additional routine or ad hoc duties as assigned based on ongoing needs assessment

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

  • MD preferred; other advanced medical degree (Pharm D, PhD) with relevant experience will also be considered
  • Previous experience in drug delivery systems helpful
  • Minimum of 5 years of experience in the biotechnology, pharmaceutical or medical device industries, preferably in Medical Affairs, Clinical Development, and/or Business Development/Alliance Management
  • Strong leadership, team building, negotiation skills and ability to execute
  • Solid understanding of drug development and life-cycle development of a product
  • Ability to understand, interpret and explain scientific research and literature
  • Able to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
  • Exceptional scientific written and verbal communication capabilities and skilled at a high level of influencing with diplomacy and capable of effectively combining science and relationship building
  • Considerable organizational awareness (e.g., inter-relationship of departments, business priorities) including experience working in a cross-functional or matrix environment and in partnership with other companies
  • Proficient at building and nurturing working relations throughout the organization and with business partners to achieve business goals
  • Knowledge of government/industry guidelines and U.S. healthcare landscape (managed markets, emergence of evidence based medicine, current regulatory environment, etc.) for appropriate scientific & medical exchanges and communication with customers
  • Ability to manage multiple projects in a fast paced environment

TECHNICAL KNOWLEDGE REQUIRED:

Equipment:   PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.  Knowledge of other equipment required: N/A

Software Knowledge:  Windows, MS Office (Outlook, Word, Excel).  Knowledge of other software required: N/A

INTERNAL AND EXTERNAL RELATIONSHIPS:

  • Interface with cross-functional colleagues across the organization and external ENHANZE partners

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:

Physical Activities:  On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required.  The noise level in the work environment is usually low to moderate.  The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities, if applicable:  Biology and chemical laboratory environments experience needed.  Environmental health and safety requirements also apply.

TRAVEL:

Travel may be required up to 30% of your time

Read Full DescriptionHide Full Description
Confirmed a day ago. Posted 30+ days ago.

Discover Similar Jobs

Suggested Articles

One Step Register
Need an account? Sign Up