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The Senior Director, Global Medical Affairs will be responsible for the support, development, and execution of Global Medical and Scientific Affairs (GMSA) plans and strategies including review of GMSA content & materials; participation in advisory boards, publication plans, life cycle strategies, and operating plans. This position will have the responsibility for managing all medical aspects of Halozyme Investigator Sponsored Trials (ISTs). They will partner closely with the Head of Global Medical and Scientific Affairs to develop integrated department strategies and plans for global support of PEGPH20 and other Halozyme development compounds
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
- Elaborate on the current standard of care (SOC) for the target diseases by developing and executing Global Medical Research (GMR) strategies (IST program, registry, other phase IV when needed) as well as performing opportunity and gap analyses
- Contribute to the development and execution of the GMSA operating plan supporting a strong and efficient department infrastructure
- Represent supported projects at scientific and medical conferences and advisory committees
- Attend and contribute to relevant scientific and medical conferences to assist in strategy development and further develop Key Opinion Leader (KOL) interactions
- Provide medical support to GMSA in developing publication strategy, reviewing and editing publications, posters, and presentations
- Participate in the review of IST proposals in regional and global review meetings and oversee the scientific review of IST protocols; Lead the IST-related communication to key internal stakeholders in collaboration with the MSLs
- Build on existing networks and establish relationships with KOLs and community Health Care Providers (HCPs); communicate and interact with MSLs and KOLs in a compliant and ethical manner in accordance with relevant SOPs
- Provide technical analysis and interpretation of data / issues that may have a potentially significant impact to medical and future commercial assessments
- Communicate existing and potential paradigm shifts in relevant cancer treatments and key competitors to guide future development strategies
- Participate in GMSA, Commercial, Clinical and Drug safety teams as appropriate to PEGPH20
- Provide medical input and support in developing clinical, scientific, and future commercial strategies
- Proactively stay abreast of current developments within the pertinent disease areas
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
- Provide solid medical leadership throughout the organization where needed
- Assist in the development of department or cross-functional SOPs and policies
- Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- A minimum of MD with at least 5+ years of experience in the biotechnology, pharmaceutical or medical device industries, preferably in Medical Affairs and/or Clinical Development (equivalent combination of experience and education may be considered)
- Strong leadership, team building, negotiation skills and ability to execute
- Prior experience working with a field-based or Medical Science Liaison (MSL) team or prior MSL / MSL management experience is an advantage
- Solid understanding of drug development and product life-cycle development
- Demonstrated fluency in the fundamental underpinnings of cancer biology, therapeutic and supportive care medicines, clinical trial design and execution
- Proven ability to understand, interpret and explain scientific research and literature
- Understanding of government/industry guidelines and U.S. healthcare landscape (managed markets, emergence of evidence based medicine, current regulatory environment, etc.) including, but not limited to, the Sunshine Act
- Effectively communicates with groups and individuals and diplomatically present ideas and document complex medical/clinical concepts
- Demonstrates cross-functional expertise and thrives in a highly complex matrixed environment both internally and externally
- Manages multiple assignments simultaneously and has strong organizational skills
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel).
INTERNAL AND EXTERNAL RELATIONSHIPS:
- Interact, collaborate, and integrate processes with functional area peers including Medical Affairs, Clinical Development, Clinical Operations, Drug Supply, Regulatory, Commercial, Preclinical, Compliance and Legal
- Lead interactions with investigators, cooperative groups and oncology research networks globally
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 may be required up to 50% of your time