Senior Medical Director, Pulmonary, Global Medical Affairs
What’s in it for you?
The Sr Medical Director, Pulmonary, reporting to the VP, Global Medical Affairs Strategy, will be responsible for providing strategic and scientific leadership for the pulmonary program, including sotatercept, the lead product in late-stage development. The successful candidate will lead the Medical Affairs sub-team to develop global medical strategy for sotatercept, in alignment with pulmonary program strategy. This individual will be accountable for strategic oversight of all medical affairs activities across regions. The successful candidate will serve as the primary point of contact for country medical teams and liaising with counterparts in R&D and Commercial.
What will you be doing?
- Represent Medical Affairs at the sotatercept program team and global brand team, serving as a strong strategic partner to internal stakeholders
- Provide strategic and scientific leadership for the sotatercept program by leading the Medical Affairs sub-team to develop global medical strategy, in alignment with pulmonary program strategy; accountable for effective execution of global medical tactics
- Provide strategic oversight for medical affairs activities across regions by partnering with Medical Planning & Operations to track key milestones
- Partner with Real-World Evidence team and other stakeholders to develop evidence generation strategy; provide medical oversight for Medical Affairs led studies, including post-hoc analyses of pivotal studies, phase 4 studies, registries; review & approve IIS & local regional study proposals
- Provide Medical Affairs input to pivotal study design, ensuring study design address key stakeholder needs
- Partner with Medical Communication to ensure timely dissemination of scientific data (e.g. publication and medical congress); review and sign off on abstracts, posters, and publications
- Provide medical oversight for key Medical Affairs content such as FAQs
- Accountable for authoring EAP protocol, medical review and approval of EAP requests
- Partner with Medical Planning & Operations to support Clinical Operations, serving as key point of contact in site selection, site engagement, study enrollment, and in select cases, study closing
- Partner with Medical Outreach to develop and implement global medical engagement plan
- Collaborate with Global Marketing to define key stakeholder engagement strategy and oversee engagement activities of global KOLs, including leading / facilitating advisory board meetings
- Support Medical Communication and Training to develop and deliver high quality scientific and skill-based training to medical team across regions
What are we looking for?
The successful candidate will possess the following capabilities and characteristics:
- MD, PhD in life sciences, or PharmD
- Located in the greater Boston area; candidates working remotely must be willing to relocate to the greater Boston area by end of 2021
- 7+ years of demonstrated high-level professional knowledge and skills in the areas of medical affairs and/or life sciences industry
- 3+ years of leadership experience in a matrix environment required
- Demonstrated reputation as a well-respected, dynamic leader with strong collaboration skills
- Prior experience working in the rare disease and/or pulmonary therapeutic area preferred but not required
- Expertise in evidence generation with an understanding of key regulatory bodies highly desired
- Strong written and verbal communication skills as well as strong leadership and interpersonal skills
- Demonstrated reputation as a well-respected, dynamic team leader
- Capable of managing shifting priorities in a rapidly changing and environment
- Travel will be required (approximately 25%)
How will you grow with us?
This role provides an exciting opportunity to be a key player in furthering the company’s goal of becoming a leader in the pulmonary space. As a rapidly growing company with multiple assets in development and key regulatory milestones on the horizon, you have an opportunity to leverage your expertise and help shape the growing Medical Affairs team. With one approved product, and an exciting pipeline, Acceleron is in a phase of dynamic growth with opportunities to make a positive impact on patients’ lives.
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
*Recruiters - please do not send unsolicited resumes to this posting.
FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:
Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) next year. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.