At Idera, our vision is to translate scientific breakthroughs into important new immunotherapies for the treatment of certain cancers and rare diseases. We have a culture where patients are at the center of all we do, with core Idera values that connect us to each other and our stakeholders and define who we are, what we stand for, and how we work.
Harnessing the approach of the earliest researchers in immunotherapy and the company's vast experience in developing proprietary immunology platforms, Idera's lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy. Idera continues to invest in research and development, and is committed to working with investigators and partners who share the common goal of addressing the unmet needs of patients suffering from rare, life-threatening diseases. Our lead product candidate, IMO-2125, has demonstrated activity in a large array of pre-clinical models and is now demonstrating proof of concept in patients through both clinical and translational outcomes in PD-1 refractory melanoma patients. We are currently readying to initiate our global Ph3 study in early 2018. We are also looking forward to 2018 when we'll review topline data from our Ph2 drial of IMO-8400 in dermatomyositis, as well as initiate an IND for our first 3GA compound
To support these exciting and important programs, we are currently looking for an Associate Director/Director of Clinical Pharmacology who will support the development of novel oligonucleotide-based therapeutics from early phase to late phase and regulatory submission with a focus on immuno-oncology and rare disease therapeutic areas. He/she will serve as the clinical pharmacology lead on all Idera clinical study teams, contributing scientific insights to clinical study and program strategies as well as have tactical responsibilities for the execution of work by bioanalytical and other vendors, including review of qualifications, data, and reports.
· Collaborate with line management and the development teams to provide scientific support for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic studies across all programs. This will include the design of the pharmacokinetic components of nonclinical and clinical studies including first-in-human, human mass balance, bioavailability and/or bioequivalence and drug-drug interaction studies.
· As an active member of clinical study teams, represent all aspects of clinical pharmacology including bioanalytical method development and validation, sample collection requirements, shipment arrangements and reconciliations, analysis and reporting schedules, and financial management.
· Provide oversight of and manage vendors.
· Author the clinical pharmacology portions of clinical trial submission documents, i.e. IMPDs, IBs, INDs, and of Common Technical Documents for regulatory submissions.
- This position requires an individual with excellent organizational, written and oral communication skills.
- The candidate must demonstrate proficiency at working independently as well as in team settings, and be able to build consensus within study teams.
- The individual must be highly self-motivated and an effective problem solver.
- Idera is a fast-paced office environment handling multiple demands. The candidate must be able to exercise appropriate judgment as necessary.
- Extensive interactions with multiple CROs and external study monitoring responsibilities require solid project management skills.
- The candidate must demonstrate strong alignment with and demonstration of all Idera values
Education and Experience Requirements
- Ph.D. or equivalent in Pharmacology, Pharmacokinetics, Pharmaceutics or related health science field.
- At least 5 years of progressive relevant industry experience (clinical pharmacology, DMPK, and/or clinical PK/PD).
- Experience developing and validating GLP bioanalytical test methods for small and large molecules (immunochemical, chromatographic, mass spectrometric, etc.).
- Hands-on experience with pharmacometrics tools such as WinNonlin and NONMEM.
- Thorough knowledge of FDA and ICH guidance documents including GLP regulations.
- Familiarity with regulatory processes and submissions.
- Experience in the conduct of Phase 1 clinical trials.
- Experience in the quantitative analysis of oligonucleotide-based therapeutics and metabolites.
- Experience in placing and managing external work at CROs.