Pharmacist Job In Waltham, Massachusetts
Program Lead (Sr. Director), Tymlos TransdermalNext Steps... Apply Now
Job ID 2019-1884
# of Openings 1
Category Clinical Dev - Dept
Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Our first commercial product, Tymlos (abaloparatide) is a synthetic analog of parathyroid hormone-related peptide (PTHrP) indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Tymlos is currently presented as a daily subcutaneous injection. Radius has worked in collaboration with 3M on the development of a patch for transdermal delivery and now has a final delivery system which is being advanced to a pivotal study. Market research suggests a transdermal delivery could significantly increase the market for anabolic therapies for osteoporosis and the ‘abalo-TD' has blockbuster potential.
We are currently seeking an experienced Program Leader/Sr. Director to join our fast paced and rapidly growing abaloparatide team to provide technical and strategic leadership for the continued development of the abalo-TD patch for the treatment of osteoporosis. The successful candidate will lead a cross functional team to support transition of the TD patch product from development to registration in collaboration with our partners at 3M and a contract manufacturing organization (CMO).
- Lead a dynamic cross functional team including representatives from Research, DMPK, Clinical, CMC, Regulatory and Commercial to develop the abaloparatide-TD patch.
- Provide oversight and strategic direction to the overall TD program and ensure product delivery in an efficient, timely and cost-effective manner.
- Work closely with Project Management to provide detailed plans with updates and regular feedback on program status to the abaloparatide commercial, LCM and executive team to ensure timelines and corporate milestones are met.
- Implement, manage, and adapt the program as needed through internal and external resources including pharmacokinetic, pharmacodynamics, and safety studies to guide the clinical development and approval.
- Assure scientific quality of the nonclinical work and integrity in the execution of clinical trials in conjunction with research, medical monitors and clinical operations team.
- Deliver regulatory filings and support external KOL discussions, collaboration discussions, and Commercial organization through product launch.
- Work closely with manufacturing partners to ensure best-in-class collaborative efforts to maintain delivery of clinical and commercial supplies of the patch
- Participate as a member of Joint Steering Committees with relevant partners
- 10+ years in a relevant discipline within the pharmaceutical and/or drug device industry (manufacturing, clinical development)
- Higher degree (MD, PhD, PharmD) preferred
- Track record of delivery of projects including bringing products to NDA/BLA and commercialization.
- Experience in various routes of drug delivery, preferred, ideally including transdermal delivery Previous experience with program leadership, proven track record in a fast-paced environment.
- Excellent presentation skills, clear written and oral communications skills.
- Proven ability to lead across functional team, and maintain external relationships with diverse audiences
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.