The Executive Medical Director, Clinical Development, will be accountable for working within a multi-disciplined core development team in the development and management of Halozyme’s oncology and PEGPH20 clinical trials in one or more tumors. This individual will provide clinical expertise and strategic insights to the Development SubTeam (DST) to help shape and inform the overall development strategy for PEGPH20 and for Halozyme’s expected growing oncology portfolio.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Lead, mentor, advise and foster the career development of a team of Clinical Development Physicians and/or Clinical Scientists
- Serve as the clinical development expert on several cross-functional teams, including DST, Clinical Collaborations, new pipeline molecules, ISTs and others
- Manage and coordinate cross-functional team meetings, facilitate discussions and develop DST-positions/recommendations for CMO-endorsement
- Represent DST and provide input to Product Development and Commercialization Strategy and work within the team to implement the clinical protocol development process in collaboration with other members of the development team, Global Product Team (GPT), and Safety Department
- Lead and support the Clinical Development activities for identified Clinical Collaboration partner and pipeline activities
- Collaborate with the safety group and be jointly responsible for the clinical safety and medical monitoring activities of multiple clinical trials, and held ultimate responsibility for clinical development plans, clinical trial protocols, data analyses, clinical study reports, and other related clinical documents
- Collaboratively assist Global Project Management in drawing up project development timelines in coordination with other functions represented on the DST
- Responsible author for clinical synopsis, outline, protocols, amendments and related documents. Lead in development of key clinical sections for regulatory submissions
- Contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards
- Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trials
- Work in collaboration with clinical operations personnel, who will provide complementary oversight of clinical trials with regard to operational aspects, and other departments within Halozyme to assure coordinated project planning
- Investigator/ site and KOL relationship management is vital; develop effective working relationships with key investigators in oncology area to optimize scientific quality/ innovation of clinical study design, execution, reporting, and publication
- First point of contact within Halozyme for the investigational study sites with regard to questions about patient eligibility in trials, protocol waivers, safety issues, regular review of safety parameters and generation of periodic safety reports, and the receipt and processing of SAEs, including review of narratives for SAEs and participation in IND expedited safety reporting
- Work closely with Medical Affairs and provide strategic input for medical affairs sponsored studies and ISTs; ensure alignment with Development sponsored studies
- Partner with Research and Pharmacology departments at Halozyme to identify and address key questions
- Provide vigorous leadership to the CRO and the Operations team, ensuring that clinical data are collated and critically evaluated at appropriate intervals to provide feedback on project progress and issues in a timely manner to team members and Halozyme management
- Coordinate real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, and biomarker data to provide consolidated information for dose escalation meetings and data reviews with investigators
- Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions
- Contribute to trial-related advisory boards; lead investigator meetings; lead protocol training meetings and support CPO’s in the conduct of regional meetings
- Develop a clinical strategy in collaboration with commercial leadership (marketing & value), reflecting the needs of the market place; assist in development of Target Product Profile, Commercial Strategy and provide input in developing strategic forecast for PEGPH20
- Collaborate with Commercial and Value Team members in interfacing with advocacy groups and holding advisory boards, representing and leading the discussion of clinical activities and plans and gathering and responding to external feedback
- Serve as the external clinical “face” of the program in interactions with development partners, and leading clinical discussions at advisory boards.
- Implement best practices and standards for trial management, including sharing lessons learned
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
- Potentially serve as DST leader
- Collaborate with Commercial and Medical Affairs to develop a strong group of Key Opinion Leaders
- Contribute to development of publication plan and directly oversee timely clinical data communication
- Play a role in post-marketing pharmacovigilance, working in conjunction with the company’s marketed drugs call center and receiving and processing post-marketing ADR reports, including the generation of narrative and completion of MedWatch forms and the authorship of Periodic Safety Update Reports
- Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- MD degreerequired with at least 4 years’ clinical research experience in oncology within biotechnology, biopharmaceutical, and/or pharmaceutical companies within a similar role (an equivalent combination of experience and education and experience may be considered)
- Prior experience with biological therapies
- Broad understanding of oncology, internal medicine and clinical pharmacology.
- Clinical experience should include the development and approval of biomarkers for patient selection and drug efficacy
- Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development, developed through success in gaining approvals.
- Intimate knowledge of and high level expertise in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).
- Demonstrated experience and expertise in the primary authorship of multiple clinical trial protocols and clinical study reports, including oversight of the generation of tables, figures and listings from the study database.
- Strong communication and collaboration skills
- Demonstrated knowledge and expertise in post-marketing pharmacovigilance, including the receipt and processing of post-marketing ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports preferred.
- Established network of external thought leaders within oncology who serve as advisers preferred
- Prior experience and expertise in the design of case report forms and the design of clinical data listing and tables for clinical trials preferred.
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:
- PEGPH20 Core team, Research & PSA, Clinical Operations, Regulatory Affairs, Statisticians and CMC. External interactions with site investigators, KOLs and regulatory authorities for clinical strategy and safety.
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.