Provide scientific oversight to clinical trial development, conduct and data interpretation in addition to providing broad scientific and/or medical input to strategic activities across the company’s matrix environment including: clinical development, medical affairs, regulatory and commercial. Represent clinical research at internal and external forums; key point of contact for scientifically-based initiatives.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Translate concepts/strategies into specific objectives and activities to effectively achieve goals
- Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.
- Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents.
- Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.
- Provide scientific expertise and support to externally facing groups, including the field medical team, medical information, research and development strategy team, and the commercial organization.
- Contribute to departmental resource planning, budgeting, and timeline setting to meet company needs
- Provide oversight and coaching to more junior medical research scientists
- Coordinate/direct scientific direction, planning, review, and interpretation of clinical trials
- Provide oversight to the development, authoring, and maintenance of clinical development plans
- Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, commercial support documents
- Provide scientific expertise and support to externally facing groups, including the field medical team, medical information, and the commercial organization.
- Lead development of specific scientific topics of interest such as those for discussion at advisory boards (Key Opinion Leader boards, safety boards, etc).
- Other duties as assigned.
Experience and Skills
- Advanced scientific degree in the life sciences. (MS, PharmD, MD or PhD) with 5 years or more direct biotechnology or pharmaceutical industry experience in clinical research and/or Medical Affairs.
- Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal or related field, preferred.
- Prior industry experience in contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents. Prior industry experience in interactions and support of Medical Affairs and Commercial groups and activities.
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
- General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and re source pressures.
- Highly proficient in standard computer software (Word, Excel and Power Point).
- Ability to travel, in some cases, internationally. (Average travel expectations: <20%/year.)
- Job Tracking ID : 85486-279858