VP or SVP, Head of Medical Affairs

4 weeks ago

Cambridge, United States Scholar Rock Full time

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

The VP or SVP, Head of Medical Affairs, reporting to the Chief Medical Officer, will be a member of the Development and Medical Affairs Leadership Team (DMLT), responsible for building and leading a high-functioning Medical Affairs team. The successful candidate will be accountable for the development and execution of medical affairs strategy and plan for Scholar Rock's portfolio of products and pipeline. This position requires a highly motivated leader with hands-on experience in evidence generation, scientific communication, stakeholder engagement, early access program, as well as experience building and leading global and regional medical teams. This individual will serve as a strong partner for counterparts in R&D and Commercial.

Position Responsibilities:

* Build and lead a strong Medical Affairs team across global and regions, accountable for effective execution of medical affairs activities; serve as a player-coach as required
* Serve as a strategic partner to internal stakeholders from R&D to Commercial
* Provide oversight for medical affairs activities across global and regions by partnering with program teams to track key milestones
* Lead a cross-functional team in a coordinated effort to develop an integrated evidence generation strategy and ensure timely execution of Medical Affairs led studies, including post-approval observational studies, disease registries, and patient surveys
* Lead cross-functional review & approval of investigator initiated studies as well as local and/or regional medical affairs study proposals
* Ensure Medical Affairs contribution to development activities, including medical input on patient reported outcome measures to pivotal study design
* Partner with Clinical Development to ensure timely and impactful communication of scientific and clinical data and effective training of internal teams
* Lead effort to ensure strong medical and scientific presence at key congresses
* Collaborate with stakeholders to develop early access strategy and plan, accountable for effective execution of early access plan
* Partner with Clinical Operations team to provide strong Medical Affairs support for company sponsored studies, including site selection, engagement, enrollment, and in select cases, study closing
* Collaborate with R&D and commercial stakeholders to develop and implement an integrated stakeholder engagement strategy and plan; oversee engagement activities of stakeholders across global and regions, including leading / facilitating advisory board meetings
* Ensure effective partnership with local and/or regional stakeholders both internally and externally to support reimbursement applications and patient access

Candidate Requirements:

* MD, PhD in life sciences, or PharmD
* Located in the greater Boston area
* 10+ years of medical affairs leadership experience, including hands-on experience in evidence generation, early access program, building and leading global and regional medical teams, is required
* Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
* Strong track record of delivering results with excellent written and verbal communication and interpersonal skills
* Capable of managing shifting priorities in a rapidly changing and environment
* Prior experience working in the neurology and/or rare diseases preferred but not required
* Ability to travel domestically and internationally (~20%)

The Special Traits of the Ideal candidate:

* Energized by a vision to change the world through innovation (in both what we do and how we do it); a catalytic leader who strives to make that happen
* Integrity in thought and action, creativity, team-centric mindset, integrative thinking, ability to influence decision-making without dictating, exceptional communication skills, the ability to inspire, and being a "hands-on doer" who leads from the front, not a "politician or presider"

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

  • Senior VP of Medical

    2 weeks ago

    Cambridge, MA, United States Beacon Therapeutics (USA) Inc Full time

    Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions for...

  • Head of Global Medical Affairs

    3 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    **Company Description** Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications...

  • Head of Global Medical Affairs

    3 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...

  • Head of Global Medical Affairs

    3 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...

  • Head of Global Medical Affairs

    3 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Company DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...

  • Head of Global Medical Affairs

    2 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Company DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...

  • Head of Global Medical Affairs

    1 week ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...

  • Head of Global Medical Affairs

    3 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....

  • Senior Vice President, Head of Global Regulatory Affairs

    1 month ago

    Cambridge, United States Beacon Therapeutics (USA) Inc Full time

    Job DescriptionJob DescriptionAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory...

  • Senior Vice President, Head of Global Regulatory Affairs

    1 month ago

    Cambridge, United States Beacon Therapeutics (USA) Inc Full time

    Job DescriptionJob DescriptionAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory...

  • Senior Vice President, Head of Global Regulatory Affairs

    2 weeks ago

    Cambridge, United States Beacon Therapeutics (USA) Inc Full time

    Job DescriptionJob DescriptionAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory...

  • Medical Director, Medical Affairs

    3 weeks ago

    Cambridge, United States Blueprint Medicines Full time

    How will your role help us transform hope into reality? The Medical Director, Medical Affairs will be responsible for development and execution of the Ayvakit / Systemic Mastocytosis medical plan and future potential allergy/immunology launches of pipeline assets as well as subsequent lifecycle management activities.  You will report to the Head of SM...

  • Medical Director, Medical Affairs

    3 weeks ago

    Cambridge, United States Blueprint Medicines Corporation Full time

    How will your role help us transform hope into reality? The Medical Director, Medical Affairs will be responsible for development and execution of the Ayvakit / Systemic Mastocytosis medical plan and future potential allergy/immunology launches of pipeline assets as well as subsequent lifecycle management activities. You will report to the Head of SM...

  • Medical Director, Medical Affairs

    2 weeks ago

    Cambridge, United States Blueprint Medicines Corporation Full time

    How will your role help us transform hope into reality? The Medical Director, Medical Affairs will be responsible for development and execution of the Ayvakit / Systemic Mastocytosis medical plan and future potential allergy/immunology launches of pipeline assets as well as subsequent lifecycle management activities. You will report to the Head of SM...

  • Senior Vice President, Head of Global Regulatory Affairs

    2 weeks ago

    Cambridge, MA, United States Beacon Therapeutics (USA) Inc Full time

    Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions...

  • Senior Director Regulatory Affairs

    3 weeks ago

    Cambridge, United States RBW Consulting Full time

    RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of autoimmune and inflammatory diseases.The candidate will report directly to the SVP of RA,...

  • Senior Director Regulatory Affairs

    3 weeks ago

    Cambridge, United States RBW Consulting Full time

    RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of autoimmune and inflammatory diseases.The candidate will report directly to the SVP of RA,...

  • Senior Director Regulatory Affairs

    1 week ago

    Cambridge, United States RBW Consulting Full time

    RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of autoimmune and inflammatory diseases.The candidate will report directly to the SVP of RA,...

  • Senior Director Regulatory Affairs

    2 weeks ago

    Cambridge, United States RBW Consulting Full time

    RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of autoimmune and inflammatory diseases.The candidate will report directly to the SVP of RA,...

  • Vice President, Head of Safety

    3 weeks ago

    Cambridge, United States Astria Therapeutics Inc Full time

    **Position Overview**: Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...