This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.
We are looking for an Associate Director of Clinical Science to join our expanding team. In collaboration with the Clinical Development and Clinical Science leaders, the Associate Director of Clinical Scientist will support the clinical program teams responsible for study design, development, execution, data readout, and summary. This position will also be a resource to teams for guidance of all matters related to analysis and communication of clinical data.
What you'll dive into
- Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management.
- Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
- Collaborates with external opinion leaders and Principal Investigators and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
- Works with study and program teams to achieve program goals and provides deliverables in approved timeframes.
- Applies best regulatory practices and drug development precedent to assigned programs.
- Supports the development of regulatory documents for filings and agency meetings
- Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
- Proactive identification of issues/problems and recommends solutions
- Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
- Maintains knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing
What we expect
- PhD or Pharm D required
- 5+ years of drug development experience with some industry (CRO or Biopharmaceutical) experience required. Academic experience a plus, as well.
- Therapeutic experience in Gastrointestinal, Dermatology or Pain preferred.
- Ability to work autonomously and with a high level of independence
- Strategic thinking skill with an ability to develop strategic plans and to justify design philosophies
- A forward-thinking contributor with the ability to lead and "own" indication-specific programs
- Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data
- Very good IT skills – ability to work with large databases
- Availability to participate in early or late meetings/teleconferences
- Able to manage priorities and competing demands in a changing work environment
- Strong oral & written scientific communications skills
- Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings)
- Ability to strike proper balance between independent work and team interaction; good team player in a cross functional team
- Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships
- Ability to travel up to 20%
What you'll get
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
- Opportunities to learn and contribute creative solutions
- Comprehensive health insurance
- Matching 401k retirement plan
- Paid time off and holidays
- Company celebrations.